Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

“Well, of course they’ll charge you, one way or another,” says Scott Jeffers, CTO of GenSight Biologics, describing what happens when your CDMO decides to move your program from one site to another – even if they initiate the move. Jeffers is a pragmatic, positive biopharma professional with advice for (anticipating and avoiding) challenges with your CDMO.

GUEST COLUMNISTS

Import Product Specifications And Drug Registration Testing For China
This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).
Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies
The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.
What If We Had Just One Developability Parameter?
Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.
Trust But Verify: Validating AI In Pharma's GxP World
Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.
What You Should Know About USP's Bioassay Updates
The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
Derisking AI Means First Asking: Who Does It Serve?
Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.
A Study In Optimizing Late-Stage Processes With QbD, DoE
Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?
Key Considerations For Materials And Components Used In CGT Manufacturing
This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.

PHARMA OUTSOURCING WHITE PAPERS

Next-Generation CRISPR Approaches
By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.

Preclinical Evaluation Of Vaccines And Antivirals In RSV Challenge SCID Mouse Models
Advance your RSV therapeutic pipeline with trusted, IND-enabling preclinical services that deliver clinically relevant data through optimized study designs and validated rodent models.
Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
Improving Safety And Efficacy With Charged Variant Characterization
Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.
Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
Designing A Disinfectant Study For Your Cleanroom
Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.