INSIGHTS ON QUALITY CONTROL

• Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality

  Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Water Activity: A Better Approach For Lyo Moisture Determination

  Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

• Development To Large-Scale cGMP Production

  For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  5/16/2024

  Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

• Seamlessly Integrating An E-WorkBook With A Customer's LIMS

  8/12/2024

  Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.

• EMPQ And Validation Support Services

  2/21/2024

  A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  11/11/2024

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Water Activity And Primary Packaging For Oral Solid Dose Products

  7/10/2024

  The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.