07.30.24 -- Making Good Decisions When FDA Investigators Come Knocking

Explore strategies that can help build an understanding of risk assessment, in addition to how to identify and address a study’s protocol requirements, drug characteristics, packaging specifications, and more.

Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

Depending on the protein or peptide of interest for your therapeutic and your manufacturing goals, there are several different manufacturing approaches, each of which can be advantageous.

Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug eluting carrier with a wide variety of APIs.

Begin your ADC manufacturing journey by finding a partner who can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.

A top global CDMO facing challenges with communicating manufacturing data and making informed decisions implemented a digital solution that improved data collection and information visibility.

Learn from industry experts about the latest advances in chemical building blocks for protein degradation, including warheads, linkers, and ligands, and their role in constructing superior degrades.

Examine the performance of a fully closed, bulk fill system and the accuracy of dispensing a range of drug substances with scaling viscosities, into variable-sized biocontainer bags or bottles.

Twin screw feeders can provide consistent and metered delivery of dry powders, directly into coating equipment.

An immediate need for lower-dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

Aside from the level of shear or ‘gentleness,’ a number of other factors help determine which type of blender will work best in certain applications. Explore considerations for blender selection.

Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process.