Process Development
Process Development
Robust and nimble approaches to drug development
Our approach to Process Development is simple: it is all about finding and implementing phase appropriate controls to ensure successful process execution during cGMP manufacturing.
Our complete solutions include process development as well as optimization of fed batch and continuous processes. We offer extensive expertise in insect cell-based production. We have experience with a wide range of expression systems, including CHO, HEK, Vero, MDCK, EB66 and insect cells.
Our solutions are tailored to meet the needs of every program and target molecule – including manufacturing of complex molecules with challenges in scale-up requiring our specialist expertise in custom solutions.
Quality is at the heart of everything we do. Quality must drive all successful production of biologics – from beginning to end.
To ensure this in our work, we use a structured approach and statistical design tools like RAPTATM for Laboratory Process Characterization (LPC) as you approach clinical late phases and commercial production.
Our local specialist teams generate and qualify scaled down-models and fully characterize process parameters in support of process validation. Extensive use is made of DOE approaches, with the support of in-house statisticians.
Ultimately, our goal is to develop high titer, scalable production processes that will express your target molecules efficiently with long-term commercial production in sight.
We offer extensive expertise in insect cell-based production. We have experience with a wide range of expression systems, including CHO, HEK, Vero, MDCK, EB66 and insect cells
PROCESS DEVELOPMENT BASED ON CHO
Chinese Hamster Ovary (CHO) cells are able to produce humanized recombinant proteins with similar post-translational modifications. Something microbial expression systems often cannot do. Moreover they grow faster, show higher protein productivity and are easier to process than other mammalian cell lines. CHO cells are well established in the industry as they are well characterized with hundreds of CHO expressed molecules in the clinic. In fact, CHO cells have emerged as the gold standard expression system in biotherapeutics production, including mAb and non-mAb.
The challenges of working with CHO
The main challenges of working with CHO are related to process development and include:
- Achieving desired product quality attributes
- Reliable process scaling (up/down)
- Robust upstream process (which is the purpose for QbD)
- Harvest challenges with high density process,
- High yield challenges to downstream
We bring experience and knowledge to your CHO program
Our experience is unsurpassed. Having worked with many CHO programs over the years, we can bring vast experience, insight and significant expertise to your program.
- Long experience in diverse CHO cells/processes (e.g. media toolbox)
- We are very familiar with an extensive number of molecules expressed in CHO, including monoclonal antibodies, bispecifics, mAb-like and Ig-fusion molecules.
- Inhouse capabilities in both traditional stainless steel production and single-use systems which is becoming a significant manufacturing platform in the cell culture space
