INSIGHTS ON QUALITY CONTROL

• Development Of Separation Methods For GLP-1 Synthetic Peptides

  Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

• Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences

  Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• Water Activity And Primary Packaging For Oral Solid Dose Products

  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.

• Contamination Control Strategy With QRM Principles

  11/19/2024

  Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Essential Insights Into Pharmaceutical Product Release: Part 2

  1/13/2025

  Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.

• 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.

• 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.