Newsletter | November 20, 2023

11.20.23 -- Everybody Wants Oligonucleotides!


Join The Clinical Supply Leader Community

We're excited to introduce a new online community focused on all aspects of clinical supply chain and logistics! Clinical Supply Leader will help you pinpoint inefficiencies in your supply chain, stay up to date on regulatory changes, identify potential supplier partners, and much more. Sign up for the free Clinical Supply Leader newsletter, delivered to your inbox weekly.


Oh, Oligonucleotides! Everybody Wants In

“We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So, it’s a deal? Hang on, says Tony Sampognaro, director, CMC project management, at oligo-focused Stoke Therapeutics.

Best Practices For Use Of Risk Registers In Biopharmaceutical Manufacturing Operations

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.


What Are The 5 Key Differences Between A Good CDMO And A Great One?

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.

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

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

Meeting Stability Testing Expectations In A Complex Pharma Landscape

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.

Considerations For Migrating From Vial To Prefilled Syringe

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

Strengthen Your IND Submission With Microbial Challenge Studies

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

GMP-Validated Adventitious Virus Testing By Next-Generation Sequencing

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

Using Advanced Mass Spectrometry To Analyze APIs And Impurities

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

The Best CDMO Fit For Small Molecule, Sterile Injectable Fill/Finish

"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.


Backpacks And Biotech With Luke Timmerman

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.


Disposable Pen For The Self-Injection Of Chronic Disease Medications

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.

Turbocharge Your Vaccine Development

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.

PreDictor Capto HIC Screening Kit

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


Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

Connect With Outsourced Pharma: