Biosimilar Manufacturing solution center

1. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

   A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

2. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

   Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

3. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

   When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

4. Speed Meets Precision With Process Development Services 11/24/2025

   Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies.

5. An End-To-End Automated HTP Platform For Cell Line Optimization 11/20/2025

   Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.

6. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

   The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

7. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

   The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

8. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

   Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

9. How One Biotech Company Is Accelerating The Drug Discovery Workflow 11/14/2025

   See how biotech innovation is accelerating drug discovery through AI, miniaturized workflows, and collaborative technologies to reshape how therapies are developed and delivered.

10. Advanced Therapies Going Mainstream: Are We There Yet? 11/14/2025

    Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.