Newsletter | November 13, 2025

11.13.25 -- We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

SPONSOR

Looking for a U.S. based CRO or CDMO? Curia’s 10 U.S. facilities and 30+ year track record can support your small molecule or biologic from curiosity to cure. Whether you’re a small startup with a big idea or an established sponsor seeking additional capacity, Curia can support your discovery, development, or manufacturing needs. Learn more.

INDUSTRY INSIGHTS

Rapid Microbiological Methods In Quality Control Of Sterile Drugs

Ensuring sterility in pharmaceutical production is one of the most critical safeguards for patient safety. Explore rapid microbiological methods growing impact on sterile drug quality control.

FAQs On The Revised EU GMP Annex 1: Volume 6

The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

Considerations For Subcutaneous, Intramuscular Formulation Development

Review the changing landscape of parenteral delivery, considering the pros and cons of intravenous, subcutaneous, and intramuscular formulations, and how new technologies are reshaping drug delivery.

FEATURED EDITORIAL

We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus on where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.

Fermentation Of Live Biotherapeutic Products In cGMP Environments

Follow the journey from master cell bank to large-scale anaerobic fermentation and the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting.

INDUSTRY INSIGHTS CONTINUED

Nanoforming Biologics, GLP-1s: From I.V. To Sub Q And Inhaled Delivery

Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.

Production Of Therapeutic Proteins In CHO Cells

The need to optimize cell culture conditions for every cell line in a product-specific manner can lead to extended timelines and substantial cost in cell line development.

Best Practices In Formulation And Lyophilization Development

Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.

Empowering Innovation: Harnessing CDMO Potential For Sterile Injectables

Specialized CDMOs are essential for meeting the growing demand and complex quality requirements for sterile injectables, providing benefits like cost savings, flexibility, and more.

How Integrated Data Systems Enhance Clinical Development

Delve into how cloud-based systems and unified data platforms are transforming biomanufacturing by enhancing efficiency, ensuring quality, and accelerating the delivery of complex therapies to market.

Generation Of A Contamination Control Strategy

An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This study details a company's journey toward sustainable compliance.

Labeling Machines Installed To Meet Stringent Requirements

To accelerate COVID-19 vaccine production, biologics contract manufacturer Catalent sought high-speed labeling machines that could be rapidly deployed.

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

A solution and partner that can help biopharmaceutical companies manage costs will be essential to achieve commercial success in a market that will only become more competitive.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

This presentation highlights the strategies executed to meet the needs of a program without sacrificing the thorough scientific evaluation of the process required for a successful validation campaign.

Best Tech Transfer Practices To Optimize Clinical And Commercial Supply

Challenges in transferring your biological product from development to manufacturing? Consider the following strategies for tech transfer, regulatory compliance, quality, and consistency.

SOLUTIONS

Delivering Global ADC Development Solutions

Gain access to industry-leading scientific capabilities, integrated platforms, and specialized expertise that help streamline antibody-drug conjugate discovery and development.

From Concept To Market: Mammalian Protein Development And Manufacturing

With proven expertise in process development, optimization, and CGMP manufacturing, Avid offers end-to-end CDMO solutions backed by flexible capacity designed to scale with program needs.

An Agile, Fully Integrated Continuous Processing Platform

With our high-productivity and single-use technology, we provide you with a continuous manufacturing approach with easy-to-modulate capacity and efficient end-to-end sustainable processes.

Accelerate Drug Development With Reliable Pharmaceutical Research

Tailored support is available for diverse molecules, including small and large molecules, nucleic acid therapies, and novel delivery systems. Services span drug substance to regulatory affairs.

Sterile Drug Product

Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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