04.10.25 -- Embracing Turnkey And Outsourced Quality Management In Biopharma

No two tech transfers are the same. To ensure success with yours, select a CDMO that will be astute in their onboarding analysis and commit to ongoing collaboration.

Oxygen heterogeneity, caused by pressure variations and other factors in large-scale bioreactors, can significantly impact cell growth and product yield.

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Are we on the same page? Do we need to be? How do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? How might this determination be relevant and essential to individual sponsors? Our Advisory Board members weigh in.

Delve into the key obstacles encountered in biologics process development, including the complexities of optimizing production processes, ensuring product consistency, and maintaining quality control.

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO? This question and others are answered here.

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

Use this study as an example for ensuring compliance with the latest EU GMP Annex 1 standards — evaluate your component quality to enhance patient safety and minimize contamination risks.

Size homogeneity of a mAb in solution is crucial for comparability and characterization. Here, an IgG1 antibody was cleaved into antigen-binding fragments via pepsin and papain digestion, then purified.

Focusing on biologics, vaccines, nucleic acids, and gene therapy, our Boston facility is now a commercially licensed site boasting a 10x 2,000L drug substance manufacturing capacity.

This brochure introduces potential problems during BLA submission, where a recent analysis of FDA complete response letters showed that 47% of the products received had CMC analytical issues.

BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.

Discover agile labeling and packaging services for pharmaceuticals, specializing in custom designs, regulatory support, and small to medium batch production with quick turnaround times.

Improve your cell line development and achieve high productivity, rapid timelines, low risk development, and robust genetic stability with an innovative platform.