INSIGHTS ON QUALITY CONTROL

• Comparative Study On Secondary Contamination Risk

  Accurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.

• Strategic CMC Planning Through A Phase-Appropriate Quality Approach

  A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

• Data Intelligence Requires An Intelligent, Data-Driven Approach To Digital Transformation

  An intelligent and data-driven digital transformation is the key to data intelligence. Discover how in 5 simple steps.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Water Activity: A Better Approach For Lyo Moisture Determination

  3/24/2025

  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.

• 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.

• A Powerful Non-Destructive Tool For Tablet Characterization

  10/6/2025

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• 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.

• The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO

  5/14/2025

  Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.