Biosimilar Manufacturing solution center

  1. Ask The Pros — The Latest In Downstream HCP Mitigation 6/20/2025

    Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

  2. 5 Key Considerations For Companies Outsourcing Process Development 6/9/2025

    Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.

  3. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

    This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

  4. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

    Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

  5. Versatile Lipid Nanoparticle Platform For Efficient Gene Editing 6/3/2025

    Lipid nanoparticles enable efficient gene editing in hard-to-transfect cells like T-cells and blood stem cells, which offers scalable, clinically relevant methods for developing advanced therapies for cancer and rare diseases.

  6. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  7. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

    Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

  8. Cross Flow Filtration Method Handbook 5/22/2025

    Discover the principles and applications of cross-flow filtration using advanced technologies, as well as learn practical steps, operational tips, and industry insights for optimal filter performance and longevity.

  9. How APBio Builds Multispecific Analytical Target Profiles 5/22/2025

    Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation.

  10. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.