Newsletter | September 9, 2025

09.09.25 -- Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

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Biologics US 2025: Bringing Biopharma Breakthroughs to life

Join us, as Biologics US 2025 gathers North America's biopharma leaders to tackle challenges in antibody and ADC R&D. See how experts are using AI-assisted design, novel protein targets, and advanced conjugation strategies to drive effective therapeutics. Don't miss keynotes from Steve Turner and Ray Deshaies, GLIMPSE-1 human-first antibody insights from Wyatt McDonnell, and our Innovations & Breakthroughs Under the Stars Garden Party. Claim your free ticket.

INDUSTRY INSIGHTS

How The Pharma Industry Is Closing Health Inequities

Leaders discuss advancing equity through inclusive trial design, access planning, and global partnerships to overcome persistent health disparities and expand access to lifesaving therapies.

Downstream Processing In Optimizing RNA-LNP Drug Development

Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

Smoothing The Path To Successful mRNA Manufacturing

Producing mRNA therapeutics requires navigating complex manufacturing challenges. A strategic partnership with an integrated CMO streamlines manufacturing processes and reduces costs.

FEATURED EDITORIAL

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

The Building Blocks Of A Robust Analytical Assay

Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

INDUSTRY INSIGHTS CONTINUED

De-Risk Your Path To Clinic With An AAV Suspension Platform

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, Ph.D., Head of Viral Vectors Commercial Development.

Targeted CRISPR/Cas9 Screen Identifies Superior HEK293 Cell Lines

Learn about two independent suspension-adapted knockout cell lines (AC003 and AC010) that show greater than 2-fold improvement in AAV9 production capacity.

Low Temperature Storage Containment For Vial And Syringe Systems

With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

Choosing The Right PBMCS For Your Research And Product Development Needs

Enhance the success of your research and cell therapy programs by sourcing PBMCs with proven functional performance and donor-specific insights.

Beyond CRISPR: Next-Gen Gene Editing With TARGATT, Mad7, Base Editing

Consider several gene editing technologies — TARGATT, Mad7, and Base Editing — and gain insights into their transformative applications in genetic engineering and therapeutic development.

Biotechnology: The Key To America's Next Manufacturing Revolution

Discover how a recent expansion into Western Pennsylvania is aiming to enable more biopharmaceutical firms to translate cutting-edge science and research into practical applications.

SOLUTIONS

Advancing Vaccines From Preclinical Development To Commercial Supply

Find development and manufacturing capabilities designed with patient safety and centricity in mind, including drug product process and formulation development and process characterization support.

Analytical Testing Capabilities

Committed to collaboration, CCS combines the technology, expertise, and capacity you need to bring your novel cell therapies from discovery to commercialization.

Advancing Innovations For mRNA Medicine Pioneers

Translating mRNA sequence to a high-quality drug product presents a complex challenge. Learn how partnering with a single contract manufacturer can alleviate potential delays and risks.

Leading CDMO: Analytical Capabilities

Find specialized development and manufacture services for new biological modalities. Discover the benefits of choosing a CDMO with complete end-to-end services and in-house analytical capabilities.

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