02.08.24 -- How To Speed Up Time To Market With CMC Knowledge Management

Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when accelerating the successful transfer of recombinant protein analytical assays.

Laser-based headspace analysis is a nondestructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.

Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

Recent advances in nanoparticle engineering technology promise to improve the success rate of new drug candidates and help push novel therapies to market.

Understand the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and the teamwork between the FDA, MHRA, and PIC/S.

Review what the president and CEO of a clinical-stage genomic medicines company had to say about growth strategy and his progress in the pursuit of gene therapies to address inherited retinal diseases.

The formulation and spray-drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, biologic, or rapid onset therapeutic.

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Discover how an innovative formulation approach helped a developer create a version of their drug that promotes treatment compliance within the geriatric population.

Explore the formulation and manufacturing of a topotecan inhaled dry powder and its use in decreasing tumor size in an animal model.