Biologic Process Development
As you move from cell line to upstream and downstream process development, BioReliance® End-to-End Solutions is the biologics CDMO partner that can help you build a robust, scalable process that brings you success now and into the future – whether your biomolecule is a monoclonal antibody, bispecific antibody, ADC, or a fusion protein.
Biologic process development services
- Full process development or transfer of your process to us for process optimization
- Media and feed screening
- Design of Experiment
- Fast-track process development programs
- Upstream process development
- Master cell bank establishment
- Downstream process development
- Formulation development
- Analytical methods development and optimization
- Biosimilars comparability analytical programs
- CMC regulatory support and GMP-compliant quality control
Flexibility and expertise end-to-end
You need an agile partner who intuitively understands your goals and not only mitigates risk, but also shares it with you. As an established CDMO we have helped bring more than 260 biologics to market while releasing more than 80 drug substance batches manufactured since 2012 compliant to GMP. Our deep expertise allows us to tailor our process to challenging timelines needed for fast-track applications or to supply clinical drug substance quickly.
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Our Track record
We won’t impose one template – instead, our 30+ years’ experience in process development means we can build a flexible working relationship around you and your changing needs. Using our deep understanding of process dynamics and our single-use technologies, we’ll design solutions with the optimal balance of risk and speed to clinic, while ensuring safety, process efficiency, and robustness across a variety of biomolecules and scales.
Because our advanced analytical development, validation, and testing are all under one roof, we can adapt our analytical packages to your specific requirements to help minimize risk and maximize process efficiency as you move though clinical trial phases. Plus, we give you the flexibility and freedom to readjust your clinical or commercial strategy whenever needed.
Facilitating tech transfer wherever you need to go
Our knowledgeable tech transfer and project management teams will ensure that your transfer is performed in a streamlined manner with appropriate documentation to form the basis for your manufacturing process, control strategy, process validation approach, and ongoing improvement. You can move forward with peace of mind – relying on our experience managing numerous commercial tech transfers and routine tech transfers internally between our development and manufacturing suites, and among our three global facilities.
Process development solutions based on skill and experience
The flexible approach of our BioReliance® End-to-End Solutions team provides customers with strong support across all aspects of their biologic process development projects, including:
- Establishing an acceptable balance of risk and speed in order to meet aggressive timelines
- Developing a robust and optimized process that successfully addresses challenges with affinity purification, host cell protein removal, and formulation
- Streamlining the transfer of CHO cell lines for development and the overall process to GMP production in an efficient and seamless manner
- Preparing clinical material and data for the Investigational New Drug (IND)/Investigational Medicinal Product Dossier (IMPD) to support approval of clinical trials on a global scale
- Leveraging expertise and capabilities of a team with more than 30 years of bringing molecules to market and decades of bioprocessing experience
Read the full case study to learn more. “MilliporeSigma respected our timeline and we initiated our clinical trial as planned. The skill and experience of the team was critical in identifying ways to accelerate the project and properly balance speed and risk.”
Contact us and discuss your timeline and strategy with our process development experts today.
Request information from our process development experts.
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