Biosimilar Manufacturing solution center

1. AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence 6/23/2025

   Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.