Bioprocessing White Papers
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Leveraging Immunological Diversity For Covid-19 Antibody Discovery
5/16/2024
Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.
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The Value Of Engaging A Single CDMO For Comprehensive Biologics Services
5/16/2024
By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.
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The Shift Toward Western Pharmaceutical Manufacturing
5/16/2024
Delve into the complexities of securing and de-risking pharmaceutical supply chains in light of vulnerabilities and prompting renewed conversations about reshoring production.
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Resource Savings Through Effective Global Trade Compliance
5/16/2024
Ensure consistent planning, accurate cost estimation, and enhanced delivery timelines for materials shipped across borders by partnering with a CDMO equipped with a dedicated trade compliance team.
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Why Should CDMOs Adhere To The New CDER's Rating System?
5/16/2024
Delve into the FDA's Quality Management Maturity (QMM) program’s benefits, the rating system’s evaluation criteria, advantages and challenges, and steps to overcome these hurdles and achieve excellence.
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Designing A Disinfectant Study For Your Clean Room
5/14/2024
Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. In this whitepaper, experts review intricacies and how to design this important study.
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Improving Safety And Efficacy With Charged Variant Characterization
5/14/2024
Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.
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Novel Cell Lysis Solution: Scaling Up The Harvest Process
5/10/2024
To ensure patient safety — as well as a portable process outside of Europe — it’s time to find a novel reagent without harmful, endocrine-disrupting properties.
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Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices
5/8/2024
Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.
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Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing
5/7/2024
For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.