Newsletter | August 30, 2024

08.30.24 -- Scaling RNA Production From The Lab To The Clinic

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AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

FOCUS ON FILL-FINISH

Scaling RNA Production From The Lab To The Clinic

Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Key Drivers To Overcome Obstacles In mAb Formulation And Fill-Finish

Discover the key strategies to overcome, aided by comprehensive support from suppliers, to streamline the formulation and fill-finish process and deliver effective mAb therapies on time.

Unlocking The Benefits Of FTZ Subzones For Pharmaceutical Manufacturing

Explore how a contract manufacturer that is approved as a certified FTZ subzone can help sponsor companies unlock significant benefits and gain a competitive edge in the global pharmaceutical industry.

FILL-FINISH SOLUTIONS

Early Drug Development Made Easy With Small Quantities - West Pharmaceutical Services, Inc.

FOCUS ON SUPPLY CHAIN

The ADC Market Is Ripening For Disruption

Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out.

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

Future Proofing The Cell And Gene Therapy Supply Chain

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

SUPPLY CHAIN SOLUTIONS

Benchtop For Lipid Nanoparticle R&D And Pre-Clinical Development - Helix Biotech

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