Upstream Process Development
The upstream process development requires a lot of human and material resources from pharmaceutical companies, which is directly related to the productivity. At an early stage, it is necessary to select suitable protein-expressing cell lines optimize culture medium and supplementation to ensure eukaryotic or prokaryotic cells are in good culture conditions, thereby increasing the expression of biologics and reducing production costs. For the development and scale-up of upstream processes, BOC Sciences provides a series of upstream process development solutions. Our experts are committed to saving you valuable time, optimizing performance, and improving feasibility and sustainability while laying the foundation for downstream success.
Advantages of our upstream process development
- Speed
With professional technique and extensive project development experience, BOC Sciences has successfully leveraged the core competencies in cell culture development to create this platform with media formulation development and quality cell line development capabilities, multiple rounds of process development, and rapid scale-up of processes
- High yield
BOC Sciences is able to successfully develop cell lines expressing target fusion proteins for our customers. Combined with excellent upstream cell culture development and purification processes, we are able to produce high quality products
- Superior technology
Our team strictly practices QbD strategy including media formulation selection, optimization, process parameter studies, critical process parameter and key process parameter determination, control strategy development, system risk assessment and control
Figure 1. Upstream production stage and process variables for transient AAV vector production. (Tony, H.; Vera, L. et al. 2017)
Our Services
To make it easier and better for researchers, BOC Sciences provides upstream process development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. BOC Sciences offers a comprehensive suite of upstream process development services, where our cell line development group and our GMP production team work closely together to ensure seamless optimization at all stages of development. Whether you need early stage cloning or media screening, detailed process optimization, or a robust commercial production process, our expert teams are ready to help.
- QbD-driven upstream process characterization
- DOE experiments for yield and quality improvement
- Screening and optimization of cell culture media, and optimization of feeds
- Cell culture process development: We can take your recombinant proteins, antibodies or hybridoma gene sequences or cDNA and design high yielding, stable cell lines in CHO, BHK, NS0, HEK-293, SP2/0 cells
- Process characterization, process optimization and process validation for late-stage clinical projects
- Assist clients in preparing CMC packages during the application process for drug approval
- Clone screening: After transfection, cells will be screened for amplification and subcloning in our specialized media platform. In addition, according to the requirement of our clients, we can generate a pool of stable transfectants and characterize them before generating a single stable clone with high yield
- Seed training and production process (fed-batch)
- Batch and continuous (perfusion) bioreactor condition development: Development and optimization of perfusion processes, development of perfusion media
- Harvesting studies
- Primary recovery development (cell lysis, centrifugation and filtration): Filtration capacity assessment
- Turbidity and particle size determination
- Upstream process scale-up, scale-down and technology transfer support
- Pilot scale / toxic run / GMP support
Figure 2. Production stages in transient AAV manufacturing. (Tony, H.; Vera, L. et al. 2017)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of upstream process development at competitive prices for global customers. Personalized and customized services of upstream process development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Tony, H.; Vera, L. et al. Development Approaches to Adenoassociated Virus Production. BioProcess International. 2017.
