Newsletter | September 11, 2025

09.11.25 -- The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies

SPONSOR

Webinar: Evaluation of a Dual Spiking strategy in Viral Clearance Studies

Are you planning your next viral clearance study? MilliporeSigma’s experts will guide you through a dual‑spiking strategy, from initial feasibility through full assay validation, showing how a single combined run can reduce sampling burden and shorten timelines. Register now!

FOCUS ON OUTSOURCING

The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies

Biopharma innovators may soon see major tax breaks thanks to the One Big Beautiful Bill Act (OBBBA). The new legislation introduces targeted tax incentives designed to strengthen domestic R&D and capital investment.

6 Key Questions When Selecting Your Cell Banking Manufacturing Partner

Evaluating a potential cell banking partner's experience, testing capabilities, and approach to material management can help guarantee the quality and consistency of your therapeutic cells.

Mastering Technology Transfers: Our Blueprint For Success

Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

Leveraging Digital Solutions To Reshape The CDMO Experience

CDMO customers consistently state that access to near real-time data is crucial to their ability to make timely, informed decisions, especially during early development.

A Deep Dive Into Expression Approaches For Biotherapeutics

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Scale-Up Allogeneic Cell Therapies To Large Patient Populations

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

Time: A Crucial Factor In Therapeutics Development

Accelerate your mRNA development and strengthen your response to emerging health threats with next-generation, cell-free DNA template solutions designed for speed, quality, and reliability.

Analytical Procedure Development Following ICH Q14

Review how the new ICH Q14 guidance and AQbD principles can transform analytical method development into a more efficient, robust, and regulatory-ready process.

SPONSOR

Webinar: Streamlining Biologics Development: Leveraging Small-Scale Studies for Greater Efficiency

Join Samsung’s expert-led webinar to discover how small-scale downstream process studies transform biologics manufacturing. Learn how data-driven approaches accelerate tech transfer, strengthen validation, and streamline regulatory approvals. Through real-world case studies, see how these studies reduce risks, save resources, and drive higher product quality—helping you bring safe, effective therapies to market faster and more efficiently. Click here to learn more.

OUTSOURCING SOLUTIONS

UpTempo AAV Platform Process - Catalent

Capacity Update July 2025: ADC - Lonza

Capacity Update April 2025: Large Molecule Development - Northway Biotech

Trusted End-To-End CDMO Partner For Your Journey - Samsung Biologics

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