Newsletter | February 12, 2026

02.12.26 -- With CDMOs Like This, Who Needs Biotechs?

SPONSOR

Webinar: Designing Drug Substance Processes for Fill-Finish Compatibility

Taking a molecule from drug substance to drug product often falters at the handoff. In this webinar, KBI Biopharma and Argonaut Manufacturing Services share how integrated CDMO-to-fill-finish partnerships eliminate silos, streamline quality, and reduce risk. Join a candid fireside chat on the top 10 quality challenges and proven solutions that cut timelines by 2–3 months from development through late-stage commercialization. Click here to learn more.

INDUSTRY INSIGHTS

Protect Patients, Ensure Regulatory Compliance With Impurity Control

A sponsor’s commitment to rigorous impurity control throughout manufacturing is vital to ensuring patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.

Fast‑Track Pharma Analytics For Resolving Manufacturing Failures

Fast‑Track pharmaceutical analytical services, identify and resolve manufacturing failures, reduce delays, control costs, and safeguard patient safety through accurate forensic analysis.

Beyond Geographies — Derisking Global Manufacturing

Gain expert insights on mitigating risks in global pharmaceutical manufacturing by learning from Joon Chang and Tracey Partington’s decades of industry experience.

FEATURED EDITORIAL

With CDMOs Like This, Who Needs Biotechs?

The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

Managing Supply Chain Risk In Scale-Up And Multisite Trials

Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

INDUSTRY INSIGHTS CONTINUED

A Sustainable Future: Phasing Out Animal Testing

Discover a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.

How To Develop Reliable, Repeatable Microbial Processes At Any Scale

Developing robust, scalable microbial fermentation depends on optimizing growth and expression phases through oxygen transfer, fine-tuning of nutrient delivery, and induction of protein expression.

Reinventing Injectable Manufacturing

As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market.

De‑Risking Generic Drug–Device ANDA Filings

This generic drug–device combination is designed for usability and regulatory compliance, demonstrating performance comparable to the reference device.

Quality By Design (QbD) For Biologics From A CDMO Perspective

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

Labeling Machines To Meet Stringent Requirements

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

Driving Operational Excellence Using Machine Learning

Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Particle Investigation: Going One Step Further Than Just The Identification

View examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting using advanced and innovative technologies.

The Importance Of Quality In Raw Material Selection

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

Reaching BLA Success: Fast-Track Approach To Process Characterization

Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

SPONSOR

BioPlan Associates is conducting its 23rd Annual Global Biopharmaceutical Manufacturing and Trends Analysis and needs your insights for the biopharma industry’s most comprehensive global benchmarking analysis! For over 20 years, BioPlan Associates has analyzed advances in bioprocessing, new technologies, and emerging trends, supported by global institutional and media partners. For all completed, qualified surveys, they'll offer an Amazon e-gift card, a copy of the summary results, and the 2026 Top Trends in Biomanufacturing White Paper.

SOLUTIONS

Discover Our DNA-Encoded Library (DEL) Technology

Uncover how DNA barcoding enables rapid screening of vast chemical space in early drug discovery, as well as how DEL platforms test billions of compounds efficiently.

New Site Tour

Take a virtual tour of a new facility to explore advanced features and assimilate how we enable scalable, sustainable performance.

Unraveling ADC Complexities With Bio-Logic Brilliance

We use our bio-logic brilliance to unravel the complexities of ADCs — empowering companies to accelerate development, enhance manufacturing efficiency, and deliver life-changing therapies.

Biorepository And Lab Services

Beyond basic storage, our comprehensive services deliver fully compliant, state-of-the-art environments where samples are meticulously cataloged, tracked, and maintained with precision.

Large Molecule Development

Site head Bill Hermans showcases our facility's specialized capabilities in Hopkinton, Massachusetts, and shares how our team serves as a true scientific partner to clients.

Comprehensive Suite Of In Vivo And In Vitro Services

Accelerate vaccine development with integrated services, supporting all common vaccine types from discovery through IND. Leverage expertise in immunogenicity, dose-response, and efficacy studies.

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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