INSIGHTS ON QUALITY CONTROL

• Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2

  Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

• HPLC Autosampler Performance I: Challenging USP Methods

  In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.

• Accelerate Your R&D And QC With These 3 Key Analysis Methods

  Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.

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

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

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  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>.

• Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres

  12/30/2024

  Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  8/22/2024

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

  6/6/2024

  Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

• 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.