Newsletter | October 25, 2024

10.25.24 -- Data Quality Issues At The Heart Of FDA's DSCSA Troubles

NEW PODCAST EPISODE

Obesity Tx End-Around With Skye Bioscience's Punit Dhillon

While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant, Skye Bioscience CEO Punit Dhillon is confident that their antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

FOCUS ON FILL-FINISH

Sterility Assurance: The Fundamentals

Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

Addressing Key Challenges Of High Concentration Formulation Development

High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.

Overcoming Challenges In CGT Development

Explore connector solutions for sterility, chemical compatibility, and ultra-low temperature challenges when setting up a therapeutic process for long-term success.

Standardization And Flexibility In Aseptic Filling

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

Considerations For Migrating From Vial To Pre-Filled Syringe

Explore some of the most relevant engineering activities that are necessary to successfully transfer a product from vial into a pre-filled syringe presentation.

Switching From Vials To PFS And Intravenous To Subcutaneous Formulations

Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

Key Considerations For Selecting Flexible Fillers

Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

FILL-FINISH SOLUTIONS

Drug Manufacturing: Yield-Maximizing Technology - Argonaut Manufacturing Services

Prefilled Syringe Manufacturing - AbbVie

FOCUS ON SUPPLY CHAIN

Data Quality Issues At The Heart Of FDA's DSCSA Troubles

Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

Cryopreservation Best Practices For Cell & Gene Therapy Source Material

Industry experts share their experiences, including why and how cellular source materials are cryopreserved and why experience across cell types and methods matters.

Master Cell Banks: Laying The Foundation To Final Product Success

By investing in the establishment and maintenance of a high-quality master cell bank (MCB), therapeutic developers can set themselves up for long-term success and ensure supply chain sustainability.

Understanding The Cold Durability Performance Of Fluoropolymer Bags

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.

SUPPLY CHAIN SOLUTIONS

Secondary Packaging For Every Single-Use Bag - Single Use Support

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