3P Biopharmaceuticals efforts have been focused on the installation of two separate rooms for the preparation of ISO5-classified cell banks with state-of-the-art biosafety cabinets based on the important development of the first phases of biologics.The professionals involved are experts in cell replication, ensuring both the purity, viability of products and the protein expression analysis.
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Cryopreservation and cell banking
1. 3P Biopharmaceuticals
3P Biopharmaceuticals is a European-based Contract Development and Manufacturing
Organization (CDMO) specialized in the process development and GMP manufacture of
biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and
commercial.
2. Biologics
3P Biopharmaceuticals offers a highly integrated range of services to support the
development and manufacture of biological products.
Custom manufacturing of biologics from mammalian, yeast, and bacterial systems are
developed from proof of concept to commercial stages being able to adapt to regulatory
requirements for every phase (GMP certified).
3. Cellbanks
Generation and characterization of
master/working cell banks
3P Biopharmaceuticals efforts have been
focused on the installation of two separate
rooms for the preparation of ISO5-
classified cell banks with state-of-the-art
biosafety cabinets based on the important
development of the first phases of
biologics.
Cell bank storage
Cell bank storageAs a fundamental part of
the chain of value of the products
manufactured by 3P Biopharmaceuticals,
storage of raw, intermediate and finished
materials at 5 ° C, -20 ° C and -80 º C can
be accommodated in control temperature in
real-time.
4. Biosynthesis Development
3P Biopharmaceuticals´R&D Department supports development and optimization of
processes offering batch, high cell density fed-batch fermentation, and perfusion,
including medium and feeding strategy.
By evaluating critical parameters of the process, such as related impurities control
from the early beginning, the Process Validation team ensures successful scale-up
and tech transfer.
5. Purification Development
3P Biopharmaceuticals supports the development of different biologics (innovative,
bio-superiors and biosimilars) defining a robust, scalable, time and cost effective
process in compliance with regulatory requirements.
R&D Department supports the
development of purification,
covering different steps of
process, such as effective
and well-controlled refolding,
tangential flow filtration,
chromatography media
selection and optimization,
virus inactivation, and
filtration.
By evaluating critical
parameters of the process,
such as related impurities
control from the early
beginning, the Process
Validation team ensures
successful scale-up and tech
transfer.