11.20.23 -- Everybody Wants Oligonucleotides!

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Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage and quickly respond to short-term needs while anticipating and planning for long-term requirements.

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

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

Diverse APIs and increased regulatory scrutiny are among the factors contributing to increased demand for microbial challenge studies to support IND submissions.

Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: next-generation sequencing (NGS), bioinformatics, and computer system validation (CSV).

Learn how CDMOs are supporting the development of advanced analytics products, including mass spectrometry, and how to optimize the analyte life cycle.

"One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, midsize, and large-scale batches.

Luke Timmerman's tireless advocacy stretches well beyond his professional coverage and punditry. Through his Timmerman Traverse initiative, he's figured out a way to weave his personal and professional passions into serving some of the philanthropic initiatives our industry cares about most. On the Business of Biotech, we'll get to know Luke personally, learn about his philanthropic work, and give listeners a healthy dose of optimism as we look ahead to the next decade in biotech.

Read about a device designed for use with a wide range of drug therapies that require variable dosing. The patient-centric design features adjustable elements and clear dose markings to support self-injection and ease of use.

Our modular approach to next-gen vaccine manufacturing is designed to integrate novel biological, analytical, or process-related technologies that can propel the industry forward.

A set of 96-well plates prefilled with six different Capto hydrophobic interaction chromatography (HIC) resins for use in high-throughput process development (HTPD).