Biosimilar Insights

  1. Streamline Bioprocesses While Meeting The Demands Of Modern Cell Culture 12/13/2024

    Xcellerex™ X-platform bioreactors offer modular, user-friendly designs with optimized scalability, adaptable automation, and standardization, enhancing productivity in pilot and cGMP cell culture operations.

  2. Pioneers And Visionaries Of Nucleic Acid And Nanoparticle-Based Therapeutics 12/12/2024

    Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.

  3. Futurizing Healthcare By Localizing The Life Sciences 12/12/2024

    Mustapha Bittaye's journey highlights the importance of international funding in fostering local scientific talent and biopharma resilience, empowering research and manufacturing in developing countries.

  4. Strike The Balance Between Cost-Effective And Risk-Averse Biologic Manufacturing 12/12/2024

    As drug sponsors continue to navigate increasing global demand for complex biologics, it is vital to assess which outsourcing strategies mitigate risk while maintaining budgets and timelines.

  5. 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.

  6. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

  7. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

  8. Best Practices For Chromatography Column Packing 12/6/2024

    Proper packing for resin is crucial to prevent issues like cracking or channeling which can lead to process disruptions and product loss.

  9. Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods 12/6/2024

    Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

  10. Guide To PUPSIT And Annex 1 In Aseptic Processing 12/5/2024

    Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.