Biosimilar Manufacturing solution center

  1. AP Biosciences' Approach To Complex Antibody Manufacturing 12/19/2024

    The bispecific developer's vice president of antibody discovery, Jhong-Jhe You, digs into the company's approach to purification and analytics.

  2. Does Your CDMO Have An Analytical Edge? 12/16/2024

    Due to the complexity of biologics, precise analytical technology is crucial throughout every phase of drug development to ensure the highest standards of quality, safety, and regulatory compliance.

  3. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  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. Cell Culture Trends To Watch In 2025 12/12/2024

    Three upstream processing experts weigh in on advancements from the past year and what they're looking forward to in the year ahead.

  6. Why Aren't QC Labs Automated? Blame Sample Container Variability 12/11/2024

    Members of the Laboratory Automation Plug and Play group speak up about the factors they see holding back quality control labs from achieving more robust automation.

  7. 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.

  8. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

    Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

  9. 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.

  10. 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.