These are the slides from a presentation "Biopharmaceutical Process Development: Good Manufacturing Practices or Breaking Bad?" given by Andrew Warr as part of the 2015 Careers After Biological Sciences programme at the University of Leicester UK
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Introduction to Bioprocessing Sample SlidesPeteDeOlympio
Introduction to Bioprocessing
Monday, January 19, 8:30 AM-5:30 PM – Tuesday, January 20, 8:30 AM-12:30 PM
View sample slides
CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles played by the analytical and formulation in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
For full details visit chi-peptalk.com/peptalk_content.aspx?id=140088&libID=140059
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Biosimilar a biological drug evaluation includes the biopharmaceutical families, the difference between small molecules and bio-pharmaceutical products, the regulatory requirements for biosimilars and the fact about biosimilars and biologic / bio pharmaceuticals the competent authorities and the key component of successful pharmacovigilane programs
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...Merck Life Sciences
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest process technologies within innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
The Improvement Programme: Making change for the betterChris Willmott
These are the slides from a talk given at the 2015 series of Careers After Biological Sciences talks by Michael Adjei-Tabirade. At the time of the presentation Michael was Project Change Manager at St George’s Healthcare NHS Trust, London.
Drugs, Keys and the Latest Fix: An insight into Medical CommunicationChris Willmott
Slides from a presentation given at the 2015 Careers After Biological Sciences event at the University of Leicester, UK. Dr Safeer Mughal, Scientific Writer at Parexel International, offered insights into working in the Medical Communications field.
Introduction to Bioprocessing Sample SlidesPeteDeOlympio
Introduction to Bioprocessing
Monday, January 19, 8:30 AM-5:30 PM – Tuesday, January 20, 8:30 AM-12:30 PM
View sample slides
CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles played by the analytical and formulation in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
For full details visit chi-peptalk.com/peptalk_content.aspx?id=140088&libID=140059
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Biosimilar a biological drug evaluation includes the biopharmaceutical families, the difference between small molecules and bio-pharmaceutical products, the regulatory requirements for biosimilars and the fact about biosimilars and biologic / bio pharmaceuticals the competent authorities and the key component of successful pharmacovigilane programs
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...Merck Life Sciences
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest process technologies within innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Does your cell line have a secret? Avoid surprises with characterizationMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2Y05bV4
The first step to avoiding an unpleasant and costly contamination event is characterization of your cell banks.
Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. We will describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that meets current regulatory expectations. Different levels of testing are performed for master, working, and end of production cell banks, and the differences in testing for each of these types of banks will be discussed.
In this webinar, you will learn:
• The types of tests that are needed to fully characterize your cell banks
• The best tests to use for your particular cell line
• Reasons why a viral contaminant may be missed
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
The Improvement Programme: Making change for the betterChris Willmott
These are the slides from a talk given at the 2015 series of Careers After Biological Sciences talks by Michael Adjei-Tabirade. At the time of the presentation Michael was Project Change Manager at St George’s Healthcare NHS Trust, London.
Drugs, Keys and the Latest Fix: An insight into Medical CommunicationChris Willmott
Slides from a presentation given at the 2015 Careers After Biological Sciences event at the University of Leicester, UK. Dr Safeer Mughal, Scientific Writer at Parexel International, offered insights into working in the Medical Communications field.
The 2015 series of Careers After Biological Sciences talks at the University of Leicester (UK) included two presentations by current PhD students. They had taken very different routes from their initial undergraduate degree into their further studies. In this presentation Dan Rogerson [BSc(Hons) Biological Sciences (Biochemistry), 2011] describes the proactive method he chose to secure his PhD place at a prestigious Cambridge laboratory.
These slides are from a presentation given by Dr Andrew Logeswaran during the 2016 season of Careers After Biological Sciences talks at the University of Leicester, UK. Having initially completed a degree in Medical Biochemistry, Andrew went on to study dentistry at the University of Central Lancashire (via an MSc).
WARNING: These slides contain images of surgery which may distress some viewers.
Slides from a presentation given by Suzanna Hawkey (Public Health England) as part of the 2016 Careers After Biological Sciences season at the University of Leicester, UK.
As well as describing her role, Suzanna gave insights into the principles of handling highly contagious organisms, and generic tips for anyone considering applying for a similar job.
The 2015 series of Careers After Biological Sciences talks at the University of Leicester (UK) included two presentations by current PhD students. They had taken very different routes from their initial undergraduate degree into their further studies. In this presentation Ananthi Ramachandran [BSc(Hons) Biological Sciences (Microbiology), 2009] describes stepping out of academia and then back into it several years later.
Slides from a presentation about her role as a teacher of the deaf, given by Deb Kent as part of the Careers After Biological Science programme in 2016.
Scientific Curation: Untangling research dataChris Willmott
These slides are from a presentation given by Dr Jackie MacArthur as part of the 2015 season of Careers After Biological Science at the University of Leicester (UK)
Device or vessel, which is designed to provide an effective environment for the conversion of one material into some product by appropriate biochemical reactions
like-enzymes, microorganisms, cells of animals and plants, subcellular structures such as chloroplasts and mitochondria
For- cell growth, enzyme production, biocatalysis, food production, milk processing, tissue engineering, algae production, protein synthesis, & anaerobic digestion
A Manufacturer’s Perspective on Innovations in BiomanufacturingKBI Biopharma
A presentation by Abhinav A. Shukla, Ph.D., KBI's Vice President of Process Development & Manufacturing delivered at the IBC’s Biopharmaceutical Development & Production Week, Huntington Beach, CA (2013)
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
Specialty pharmacist Stevan Lalich of CVS Health breaks down the differences between biosimilar, biologic, generic, and brand name drugs – and why it’s important! In this comprehensive webinar, learn about the medicines in your cabinet and the process they endure before reaching you. This is a timely and unique webinar not to be missed
How the use of multimedia enhances teaching, learning and researchChris Willmott
Slides from a webinar delivered by Dr Chris Willmott (University of Leicester) on behalf of Learning on Screen and Association of Learning Technologists (ALT).
Chris discussed the use of Box of Broadcasts (BoB) in university teaching, illustrating the potential with examples from his own practice. He also discussed the emerging potential of BoB as a tool for multimedia research
Slides from a presentation given by Holly Large, Emma Sewell (in absentia) and Dr Chris Willmott at the launch of our guide on the use of BoB ("Box of Broadcasts" and TRILT (the Television and Radio Index for Learning and Teaching) as tools for academic research. The launch event took place in London on 23rd September 2022.
"Discussion boards don’t work": Evaluation of a course blog for teaching with...Chris Willmott
Slides from a presentation given at the Horizons in STEM Higher Education (Virtual) Conference, 30th June 2021. I discussed an initiative in which students had been asked to contribute to a "Shared Resource Collection" instead of a terminal exam paper. The trial was only partially successful, as demonstrated by the data in the presentation (and additional data after the final "Any Questions" slide, which was not shared at the event.
Journal Club: Role of Active Learning on Closing Attainment GapChris Willmott
Slides from a Biological Sciences Scholarship of Learning & Teaching journal club held at the University of Leicester (UK) in May 2021. We discussed Theobald et al. (2020) Active learning narrows achievement gaps for underrepresented students in undergraduate science, technology, engineering, and math PNAS 117:6476-6483. Note slides relating to Fig 2 have been edited after the meeting to better reflect the discussion on the day.
Turning teaching innovations into education publicationsChris Willmott
Slides from a workshop run [online] on behalf of colleagues within Biological Sciences at the University of Leicester (UK). One or two of the slides are specific to local context, but most are pertinent for anyone wanting to get started in educational research by looking to make evaluation of their existing or future teaching initiatives more robust.
Analysis of Broadcast Science as a Capstone ProjectChris Willmott
Slides from a presentation delivered virtually (via Zoom) on 20th May 2020, in the #DryLabsRealScience series as UK Universities seek to adapt some of their teaching and projects to online formats
Measuring actual learning versus feelings of learning (Journal Club)Chris Willmott
Slides from Bioscience Pedagogic Research Journal Club meeting at the University of Leicester, UK. The meeting discussed "Measuring actual learning versus feeling of learning in response to being actively engaged in the classroom" a study by Louis Deslauriers and colleagues at Harvard University.
Do you know Bob? Adventures with technology-based resources for teaching (and...Chris Willmott
Slides from a presentation about the Box of Broadcasts resource, and creative uses of lecture capture technology. Talk given at the Dept of Molecular and Cell Biology, University of Leicester in April 2019.
Adventures in Flipping the Teaching: A bioethical exampleChris Willmott
Slides from a presentation given at the AdvanceHE STEM Teaching and Learning Conference in January 2019. The talk is a warts and all description of a four year journey trying to develop flipped lectures for teaching core bioethics to second year undergraduates at the University of Leicester, UK
Teaching ethics in the UK: A Bioscience perspectiveChris Willmott
Slides from a presentation given via Skype to the First International Bioethics Conference, on Teaching and Learning in Bioethics. The meeting was organised by Víctor Grífols i Lucas Foundation and held at the Universitat de Vic - Universitat Central de Catalunya in January 2019. The talk was a personal reflection on the teaching of ethics to bioscience students as it has occurred over the past 17 years or so.
A back-up version of the talk (in case of technical difficulties) was recorded and is available at https://youtu.be/JS--0SDAYTk.
Pedagogy Involving Capture Technology: Uses of Panopto beyond the recording o...Chris Willmott
Slides from a presentation given at the Advance HE STEM Conference at Millennium Point, Birmingham in January 2019. The talk described the current status of the Pedagogy Involving Capture Technology (PICT) project, looking at innovative ways of using Lecture Capture tools for purposes over and above standard lecture recording.
As Seen On TV: Using broadcast media in university teachingChris Willmott
Slides from a presentation given at Lights, Camera, Learning: Teaching with the moving image - a conference held at Birkbeck, University of London in November 2018. The event marked the 70th anniversary of the setting up of the organisation known now as Learning on Screen (http://bufvc.ac.uk)
Not so flippin' easy: Adventures in "flipped teaching" in the biosciencesChris Willmott
Slides from a presentation given to the Biological Sciences Scholarship of Teaching and Learning group at the University of Leicester (November 2018). The talk gave a step-by-step reflection on the evolution of bioethics teaching via a combination of online videos and face-to-face discussion of case studies. As noted, aspect of the process remain problematic.
As Seen On TV: Promoting the use of broadcast media in HEChris Willmott
Slides from a presentation given at Dalhousie University (Halifax, Nova Scotia) in May 2018. The talk discussed work on developing resources to promote the use of television and radio in teaching.
Developing WordPress blogs as shared educational resources: some practical tipsChris Willmott
These are the slides I prepared for an innovative Twitter conference held on 29th March 2018. The #PressEDconf18 event organised by Natalie Lafferty (@nlafferty) and Pat Lockley (@pgogy) focused on educational uses of WordPress. Each speaker had 15 tweets, one per minute for 15 minutes. I chose to plan my contribution out as a standard PowerPoint presentations for which I turned each slide into a separate JPG to embed in my tweets.
As Seen On TV: Using broadcast media in university teachingChris Willmott
Slides for a presentation promoting the use of "BoB", an online repository of TV and radio programmes for education. This presentation was given at the Education in a Digital Age event at the University of Lincoln, UK, in November 2017.
RSB CPD PDG IMHO: A mechanism for capturing your “evidence”Chris Willmott
Slides from a presentation describing the merits of the Royal Society of Biology's CPD scheme. I can take no credit for the creation of the scheme, but have found it an extremely helpful way to capture the kind of "evidence" of ongoing professional development which is required for appraisals, awards and applications. This talk was given at BioSummit2017, an annual gathering of teaching-dominant UK Bioscience academics.
Turning teaching initiatives into pedagogic publicationsChris Willmott
Slides from keynote presentation at Discovering Teaching Excellence at Leicester event, July 2017.
The talk outlines some lessons I have learnt about getting started in publication of pedagogic research and other education-related publications.
Want to move your career forward? Looking to build your leadership skills while helping others learn, grow, and improve their skills? Seeking someone who can guide you in achieving these goals?
You can accomplish this through a mentoring partnership. Learn more about the PMISSC Mentoring Program, where you’ll discover the incredible benefits of becoming a mentor or mentee. This program is designed to foster professional growth, enhance skills, and build a strong network within the project management community. Whether you're looking to share your expertise or seeking guidance to advance your career, the PMI Mentoring Program offers valuable opportunities for personal and professional development.
Watch this to learn:
* Overview of the PMISSC Mentoring Program: Mission, vision, and objectives.
* Benefits for Volunteer Mentors: Professional development, networking, personal satisfaction, and recognition.
* Advantages for Mentees: Career advancement, skill development, networking, and confidence building.
* Program Structure and Expectations: Mentor-mentee matching process, program phases, and time commitment.
* Success Stories and Testimonials: Inspiring examples from past participants.
* How to Get Involved: Steps to participate and resources available for support throughout the program.
Learn how you can make a difference in the project management community and take the next step in your professional journey.
About Hector Del Castillo
Hector is VP of Professional Development at the PMI Silver Spring Chapter, and CEO of Bold PM. He's a mid-market growth product executive and changemaker. He works with mid-market product-driven software executives to solve their biggest growth problems. He scales product growth, optimizes ops and builds loyal customers. He has reduced customer churn 33%, and boosted sales 47% for clients. He makes a significant impact by building and launching world-changing AI-powered products. If you're looking for an engaging and inspiring speaker to spark creativity and innovation within your organization, set up an appointment to discuss your specific needs and identify a suitable topic to inspire your audience at your next corporate conference, symposium, executive summit, or planning retreat.
About PMI Silver Spring Chapter
We are a branch of the Project Management Institute. We offer a platform for project management professionals in Silver Spring, MD, and the DC/Baltimore metro area. Monthly meetings facilitate networking, knowledge sharing, and professional development. For event details, visit pmissc.org.
This comprehensive program covers essential aspects of performance marketing, growth strategies, and tactics, such as search engine optimization (SEO), pay-per-click (PPC) advertising, content marketing, social media marketing, and more
3. Overview
1. Overview of Biopharmaceutical Industry
2. Process Development
1. What is PD?
2. ‘Andrew, what do you actually do?’
3. Actavis Biologics
1. Who are they?
2. What do they do?
4. Advice. Leicester to Liverpool. Questions.
4. What is a Biopharmaceutical?
‘A biopharmaceutical, also known as a biologic medical product or more simply as a
biologic, is any medicinal product manufactured in or extracted from biological sources.’
Most often used to describe products that are produced by recombinant DNA
technology
Monoclonal antibodies (mAbs)
Hormones
First approved commercial product was Humulin® (Genentech/Eli Lilly), 1982
Biosimilars
‘A drug similar to a biologic drug that has already been approved (the “originator”). The
active ingredient of a biosimilar is like that contained in the originator biologic.’
Biologics made by different manufacturers differ from the original product and from
each other.
5. Good Manufacturing Practices or Breaking Bad?
Activities in the development and manufacture of therapeutic products to help ensure
that a manufacturer can consistently control and produce these products to meet the
identity, strength, purity and quality appropriate to their intended use.
Qualified and trained personnel
Materials must meet specified quality attributes
Standard Operating Procedures (SOPs) must be established and followed
• manufacture, testing, cleaning, validation
Facilities must be suitable for their intended purpose with proper lighting, air handling, plumbing
and sanitation
Records to demonstrate GMP compliance must be properly maintained
6. “One that is not only safe and efficacious, but that patients don’t dread taking to the
point that they don’t take their medication.”
“A product that meets the patients requirements, in a manner that can be supported by the
local healthcare provider, with a supply chain that can reliably support demand, whilst
creating a return on investment to the developer of the product.”
“From a manufacturer’s perspective, a successful commercial biological product is
one with a robust process that can be manufactured time and time again to give a
consistent product that meets the regulatory specification.”
“ The best commercial products are those that significantly improve patient lives
(with minimal adverse events) and have a reliability of supply.”
“Firstly there’s a need for the product, secondly the product is
efficacious and thirdly it’s cost effective.”
What Makes a Successful Biological Product?
12. What Do Process Development Scientists Do?
Devise new, or refine existing processes to optimise the performance of the
manufacturing process
Improve the efficiency and profitability of the manufacturing process by reducing
cost of goods, or implementing new technology to improve efficiency
Implement process controls to make sure the products are of a high quality and are
manufactured in a reproducible manner
Scale up the production process via plant trials, making changes to process
parameters to ensure quality is maintained during large scale production
Technical reports and specifications
14. Host Line Example Product Examples
Chinese Hamster Ovary
(CHO)
CHOK1 Activase®
Murine Sp2/0, NS0 Remicade®, Erbitux®,
Synagis®
Cell Line Development
CHO as the ‘Industry Standard’
8 out of top-ten selling biologics are produced in mammalian cells
7 produced in CHO cells
$57 billion sales (2011)
Why?
Well characterised with high titres
Propagate few human viruses
Allow post-translational modifications
16. Fed-batch and perfusion processes
Mixing achieved by one or two impellers
Gas mass transfer via gas sparging
2 – 10 L bench top at lab-scale (glass / polycarbonate)
Up to 20000 L production scale (stainless steel) / 2000 L single-use
Stirred Tank Bioreactors
Feed Alkali
pH
temp
DO
Gases:
Air, N2,
CO2, O2
RPM
17. Fed-Batch Processes
+ Relatively simple, flexible, and potentially shorter time to develop
+ Typically 10 – 14 days
+ Concentrated feed addition
+ VCD up to 10 – 20 x106 cells / mL
+ 2 – 5 g/L product titre
+ Single harvest
--- Waste products build up during culture
18. Perfusion Processes
+ Longer run duration than fed-batch
+ ~1.0 g/L/day
+ Smaller vessels may be used compared to fed-batch
+ Fresh medium added and waste medium (waste metabolites) removed
continuously at same rate
1. Extended fed-batch: Product retained within bioreactor and purified as
single harvest (~20 days, ultra-high VCD, 10x
productivity)
2. Perfusion: Continuous product harvest from bioreactor and purified in
multiple batches (up to 60 days)
Future: continuous upstream and downstream to increase speed and efficiency
20. Bioreactor Process Optimisation
Shake flasks, mini- or lab-scale bioreactors
Design of experiments (DoE) studies to evaluate interactions between multiple
variables
Medium / feed components, culture duration, bioreactor control parameters (pH,
DOT, temperature, pCO2)
Maximise growth, productivity, product quality
1. Increase the time integral of viable cell concentration (IVC)
2. Increase the specific production rate (Qp) of the cells
22. Founded in Liverpool as Eden Biodesign in 2000
Originally a CMO before being acquired by Watson Pharmaceuticals in 2010
Grown to approx. 180 employees
Actavis’ Centre of Excellence for the development and manufacture of all biologics
Process development and GMP manufacturing
Single use facility
Actavis Biologics
24. Leicester to Liverpool
1. Experience
Industrial placement year
Summer placement
Volunteer
2. Interview
Prepare
Question
Relax
3. Open mind
CABS
Do you already know what you want to do?
Relocation
25. Why Do I Like My Job?
1. Relevant and rewarding
2. Perspective
3. Biotechnology is at the forefront of healthcare
4. Travel
5. “I’ve never met a scientist before”