Newsletter | January 10, 2025

01.10.25 -- FDA: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics

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FEATURED EDITORIAL

FDA: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics

FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14.

2024 Review: It Was Your Moment In Outsourcing History

This past year sent us a harsh reminder: None of us are paragons of outsourcing sagacity. We need to keep learning, updating, and staying aware that the outside world – history in the making– interferes. Here's a review of a historic year that will get you thinking: How did I create outsourcing history in 2024?

INDUSTRY INSIGHTS

5 Things To Consider In Pharmaceutical Labeling

Explore key considerations for ensuring accuracy and efficiency in your labeling process, from robust control systems to diverse printing options and comprehensive qualification.

Work With An In-Country Clinical Trial Depot For Efficiency And Compliance

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Identify Lead Solid Form Early To Reduce Timelines And Downstream Costs

Devoting early-phase resources for solid form understanding and screening during a drug’s development lifecycle is critical, as doing so can help save time and resources on the path to market.

Nasal Vaccine Development, Manufacturing, And Device Selection

When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

Contamination Control Strategy With QRM Principles

Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

A Framework For Identifying Nitrosamine Risks And Derisking Products

Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

Improving An Abandoned Cancer Medication Using Innovative ASD Technology

Review the results of this study and learn how KinetiSol Solid Dispersion lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

SOLUTIONS

Capacity Update October 2024: Small Molecule

Use our services and solutions to advance small molecule development — from initial design and optimization to full-scale manufacturing and comprehensive analytical support.

Nitrosamine Capabilities

Pinpoint impurities and conduct confirmatory testing under cGMP with the help of an expert team utilizing cutting-edge mass spectrometry technology to boost your drug product development.

Process Development And Preclinical Manufacturing — India

Experience how a global network and cost-efficient model can simplify outsourcing for your discovery, preclinical, clinical, and commercial NCE programs.

OUTSOURCED PHARMA CAPACITY UPDATE

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.

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