Biosimilar Manufacturing solution center

  1. Deploy AI To Become A cGMP "Special Agent" With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

  2. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

  3. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  4. Keep An Eye On These Analytical And Monitoring Trends In 2025 12/20/2024

    Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.

  5. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.