CELL LINE DEVELOPMENT
SCALE UP & GMP MANUFACTURING
Cell line development
An effective development program hinges on the generation of a robust and dependable cell line.
Recognizing the importance of this activity, and how a good starting point will optimize your success, 3P Biopharmaceuticals offers to manage your cell line development.
Our expertise covers the entire process, from ensuring the amino acid or nucleotide sequence to generating a stable Research Cell Bank (RCB) that will be thoroughly characterized to give confidence for superior performance.
As this activity is also key for CMC documentation, 3P ensures full traceability of all operations performed, as well as a complete history of the cell line, vector and plasmid used to construct the final RCB.
3P biopharmaceuticals also has capabilities to generate your Master Cell Bank (MCB) and/or Working Cell Bank (WCB) to deliver reproducible quality and safety during commercial production.
Robust and scalable processes
We understand that the time to market for your biologics can make all the difference to patients waiting for valuable therapeutic options.
For this reason, 3P´s highly experienced professionals are constantly focused on developing scalable, efficient processes that can be smoothly transferred to our larger scales in order to minimize time-to-market.
The time “spent” in our laboratory is an investment for the future of your project and our development platforms result in robust, scalable and well-controlled processes with excellent reproducibility when facing non-clinical and clinical phases.
Our dedicated team of scientists and analysts have the skills and knowledge to develop processes to meet your project goals in a high-quality and cost-effective way.
A unique combination of know-how, use of the latest technologies / equipment, and our team spirit allow us to effectively and efficiently work with you to drive product development forward to achieve successful commercial manufacturing.
- INDUSTRIAL VISION
Process development capacities:
- Biostat B twin 2x2L +2x2L
- Biostat B DCU 2x2L + 1x10L
Experience, knowledge and innovation
At 3P Biopharmaceuticals, we understand your time, cost and quality pressures. For this reason, we are committed to exceeding your expectations by providing tailored, flexible and cost-effective manufacturing solutions.
As a robust microbial manufacturing partner, we combine our knowledge, experience and state-of-the-art equipment for your biologics manufacturing.
As part of our one-stop-shop service we also offer a wide variety of in-house analytical testing and release capabilities to support the quality manufacturing of your clinical or commercial stage product.
Cell line experience:
- E. Coli
- S. Cerevisiae
- P. Pastoris
- H. Pylori
- S. Noursei