Newsletter | May 15, 2025

05.15.25 -- Trump-Era Tax Cuts Spark $27B U.S. Manufacturing Surge

SPONSOR

Did you know Catalent offers contracted analytical services?

With over 30+ years of experience, Catalent offers a comprehensive suite of orthogonal GMP analytical services for all biological modalities, from discovery to commercial phases. Our seasoned experts ensure exceptional on-time delivery and client satisfaction by providing tailored solutions to meet your unique needs—no matter the complexity, scale, or timeline. Watch our intro video to learn more about our capabilities!

INDUSTRY INSIGHTS

Strategies For Efficient Clinical Supply Management And Forecasting

Drive excellence in clinical trials by utilizing forecasting to better plan clinical supply budgets and project timelines, and identify potential supply-related issues before they negatively impact a study.

Conduct Early-Phase Studies To Improve Manufacturability, Mitigate Risk

While clinical efficacy is the critical benchmark for any drug program, ensuring manufacturability is also vital. An experienced CDMO can help you establish efficient and cost-effective production strategies.

Microbial Biomanufacturing: Where We've Been And Where We Are Going

Learn about the cutting-edge technologies driving the shift to microbial expression and how the right outsourcing partner can help you leverage the benefits of these innovative therapeutics.

FEATURED EDITORIAL

Lilly's CEO Building On The Trump Agenda

“We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, D.C. — plans to invest $27 billion to build four new manufacturing plants in the country.

EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines

The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, guiding manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

INDUSTRY INSIGHTS CONTINUED

Clinical And Formulation Strategies For Targeted Peptide Delivery

Novel technologies and therapies are helping drug developers to overcome challenges associated with the development of injectable and oral peptide formulations.

Understanding Process Development Of ADC In Preclinical, Early Phase Trials

Examine a platform process that is emerging as a simplified and reliable solution for ADC manufacturing, offering efficient process development, purification techniques, and optimization strategies.

5 Advantages Of Dual-Sourcing In Pharmaceutical Fill/Finish

Delve into the specific advantages of dual-sourcing in pharmaceutical fill/finish, exploring how this approach can bolster supply chain resilience, increase capacity, and accelerate commercialization.

Process Development For Lyophilized Products

Utilize this approach in identifying potential product failure points and designing robust formulations and processes for lyophilized products backed by solid data.

Analytical Strategies To Address Common Development Challenges

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Form Fill And Seal Label Applicator For Drug Packaging

Consider a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

As biosimilar development continues to accelerate, with nearly $112 billion in biologic medicines set to lose exclusivity in the global market by 2025, the market is becoming increasingly competitive.

Building More Resilient API Supply Chains

It is important to pursue a dualistic, longer-term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

SPONSOR

Webinar: Optimizing Biotherapeutic Protein Expression with Novel GS® CHO Vector Technology

Recombinant protein production is evolving to meet growing demand. CHO-based systems remain central, but further innovation is needed. Join us on May 19th to learn how Lonza is enhancing its GS® expression vector technology with a high-strength synthetic promoter to boost yields, maintain quality, and support efficient biomanufacturing across diverse therapeutic proteins. Click here to register.

SOLUTIONS

Plant 5 — Dream Plant: Within Your Reach. Built For Your Success.

Finding a CDMO committed to increasing capacity and optimizing processes with innovative technologies is key for adding efficiency while maintaining high-quality standards.

Be A Gain Changer With 2x Throughput

Cytiva Supor™ Prime filters reduce product loss to waste, ensuring every drop counts towards maximizing your yield. Watch this product overview video to learn more.

ATON Bio Capacity Update July 2024: Large Molecule Development

This presentation from the July 2024 OPCU event discusses how unifying key functions, experience, and broad capabilities can accelerate more pipelines to market.

End-To-End Capacity With Flexibility, Infrastructure, And Expertise

A strong manufacturing platform can make or break a biologic therapy — enabling rapid scaling, supply chain efficiency, faster therapy availability, and reduced shortage risk.

Experience That Accelerates Success

With cutting-edge technologies, regulatory excellence, and a commitment to quality, we provide seamless support tailored to your specific needs.

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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