The best process development for your protein project
Published on 2018-09-04 Process development
Advice from GTP’s experts to help you define and develop the best process for your recombinant protein and antibody project.
Protein process development can be tricky. When your recombinant protein or monoclonal antibody has completed the research stage and is ready for clinical trials, you need to build a convincing preclinical package that demonstrates your project’s potential to partners and investors. To achieve this feat, you’ll want to stack all the odds in your favor to set your project up for success. Here’s some advice from GTP’s experts to help you stay on track:
Pick your CDMO with care
For a wide range of proteins and antibodies, the development and manufacturing processes are already well documented and a wide range of CDMO’s can help you on your way. However, when very little information regarding the manufacturability of your molecule is available, only a few CDMOs have the expertise and know-how to take biotherapeutic projects from the lab bench all the way to the manufacturing unit. With its unique mix of protein research proficiency and process expertise, GTP is definitely one of them. GTP is a science-driven and customer-oriented Contract Development and Manufacturing Organization (CDMO).
Gather a convincing preclinical package
The initial feasibility study and the production of research material are crucial to the success of your biotherapeutic development program and they should be approached from an agile and global perspective. GTP’s experts combine extensive know-how in challenging recombinant proteins with high-end expertise in protein process development and a vivid scientific interest in unconventional protein development projects. Our unique expertise in protein process development makes us the ideal partner to demonstrate the industrial potential of your protein or monoclonal antibody candidate and develop the best process for its production.
Case study: a vaccine for placental malaria
As shown in our case study for the development of a vaccine for Placental Malaria, GTP can facilitate the preclinical development of your molecule. This project was started at POC stage by a multi-system feasibility study in order to define the suitable expression system. GTP then developed the complete production process that was transferred to a CMO for further GMP grade manufacturing.
Adapt your process to your specific protein
The GTP team advises on the most efficient and least risky strategy for your program. We’re convinced that the process makes the protein and focus on developing the best upstream and downstream processes for your specific molecule. During process development, we work in close relationship with your preferred CMO or our selected CMO partners, to make sure the developed process fits the CMO’s practices.
Versatile upstream process development
Our upstream development skills cover both cell culture (CHO, HEK) and microbial (E. coli, P. pastoris) fermentation. They range from small to pilot scale. During upstream process development our focus will be on developing high-expressing strains and cell lines and efficient & robust batch or fed-batch processes.
Unique expertise in downstream development
When considering the development of a purification process, each protein represents a unique challenge. Thanks to our long history in working with a wide diversity of proteins, our scientists have acquired the agility to customize downstream processes and adapt them to each specific case. Our purification team can develop processes from scratch or optimize existing processes. For challenging proteins that cannot be handled via established standards, we bring innovation to the process while keeping process transferability in mind.
Benefit from an exceptional track record
The GTP team has a unique track record to vouch for its extensive experience in the development of upstream and downstream processes for a wide range of proteins: antibodies, antibody fragments, enzymes, cytokines, growth factors, hormones, receptors, transcription factors…
Over the past 15 years, we have supported 100+ biopharmaceutical companies to meet a variety of needs:
Production of small batches during early drug discovery programmes
Complete process development and transfer to cGMP manufacturing for vaccine and therapeutic proteins
Gram scale batch productions of therapeutic proteins and antibodies for preclinical in vivo studies
Come and meet us at BioSpain & Nordic Life Science Days
The GTP team will attend Nordic Life Science Days in Stockholm, on September 11, and BioSpain in Seville, on September 26 and 27. If you have questions regarding a specific project, don’t hesitate to contact us to schedule your meeting. We’re already looking forward to meeting you there!