Insights On CONTRACT PHARMA MANUFACTURING

  1. Reducing CMC Risk With Proven Analytical And Formulation Expertise 7/28/2025

    Explore real examples of how this outsourcing partner helps drug sponsors through transparency that empowers, integration that simplifies, methods that de-risk, and experience that accelerates.

  2. Innovation That Is Evolving The CGT Landscape In 2025 7/28/2025

    Uncover how cell and gene therapy leaders are adapting to funding pressures, regulatory shifts, and global complexity by prioritizing scalability and strategic partnerships for long-term success.

  3. Contract GMP Biologics Analytical Services 7/28/2025

    Pedro Morales, Director, Scientific Advisor of Biologics Analytical Services, explores how Catalent delivers tailored solutions through deep expertise and advanced capabilities.

  4. Alcami Capacity Update July 2025: Analytical Services 7/28/2025

    Alcami’s laboratory services can support many drug substance or drug product modalities, all product phases, and specialty laboratory services, including in-house microbiology, raw materials, and analytical development.

  5. MilliporeSigma Capacity Update July 2025: ADC 7/28/2025

    MilliporeSigma and Simtra's streamlined collaboration encompasses every stage, including bioconjugation, linker and payload supplies, formulation development, and final fill/finish of drug substance.

  6. Integrated ADC Offering: From Concept To Commercialization 7/28/2025

    Leveraging deep ADC expertise and experience, successfully develop high quality, commercially viable processes, spanning from pre-clinical development through commercial scale manufacturing.

  7. The Story Behind 20 Years Of Success 7/25/2025

    Beth DiPaolo, SVP, recounts how the company started with a client who needed a tailored service model to meet a scope of work they would never outsource, laying the foundation for a client-focused culture.

  8. Optimizing Contamination Control: Strategy Planning And Execution For Facility Compliance 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  9. Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny? 7/25/2025

    Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

     

  10. Guiding Principles For Process Development And IND Readiness 7/25/2025

    Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.