Newsletter | October 30, 2025

10.30.25 -- Will It Not Die? The BIOSECURE Act Back With Iterations

SPONSOR

With more than 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class GMP sterile fill and finish services, deep scientific and technical expertise, and a uniquely collaborative approach to support our customers’ strategic objectives. As two industry-leading CDMOs in the ADC field, MilliporeSigma and Simtra have forged a Strategic Alliance for Drug Substance and Drug Product ADC Manufacturing with the shared goal to delivering your drug development program to market more efficiently.

INDUSTRY INSIGHTS

Streamlining ADC Development: Advantage Of An All-In-One Solution

Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

Successful Completion Of The Project NaDiNa

Conducted alongside the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project translated research into a viable medicinal product.

Optimize Your mAb Capture And Polishing With The Latest Resins And Tips

This session aims to equip viewers with practical knowledge to optimize their purification strategies, enhance product quality, and streamline manufacturing processes.

FEATURED EDITORIAL

Will It Not Die? The BIOSECURE Act Back With Iterations

Chief Editor Louis Garguilo believes WuXi AppTec should take this as a dose of vindication. Even a partial victory. Supporters persuaded the Senate to NOT include WuXi in the BIOSECURE Act. Here’s an analysis of this current situation that can affect anyone outsourcing drug development and manufacturing.

Reactive, Proactive, Or Inherited? Managing Supply Chains

Lynn Cinelli, recent VP Global Biologics Supply Chain at Bristol Myers Squibb, provides her insights on selecting and managing external development and manufacturing partners.

INDUSTRY INSIGHTS CONTINUED

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.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two studies that explore factors contributing to fogging and inform selection decisions.

Optimizing The Path To First-In-Human Clinical Trials: Design And De-Risk

Explore the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Enhanced Cell Line Development Platform

Leveraging deep expertise in biologics development, AbZelectPRO™ streamlines the IND application pathway, ensuring smooth progression into clinical phases.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

SPONSOR

Live Event: Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right

This digital event features industry experts who will share best practices for streamlining processes between sponsors and CDMOs. Register today for free and you can walk away with actionable insights into aligning analytical methods and quality standards to accelerate small molecule production and reduce risk across the development lifecycle.

SOLUTIONS

Accelerate Your AAV Program Toward Clinical Success

From plasmid design to vial-ready product, our proprietary AAVion® platform streamlines every step to accelerate your AAV program toward clinical success.

Manufacturing Services For Therapies That Define Legacies

Gain direct access to our extensive global network of sites, along with the benefits of seamless process optimization, scalable commercial manufacturing solutions, and secure, dependable supply chains.

Capabilities Update July 2025: Large Molecule Drug Substance

Thomas Kohl, Director of Business Development, shares the company’s microbial and mammalian capabilities and their available capacity.

Pull Your Fill/Finish Line Closer

By partnering with us, you gain access to our unique, interconnected network, purpose-built to overcome the breakpoints common in traditional manufacturing models.

Integrated ADC Offering: From Concept To Commercialization

Leveraging deep ADC expertise and experience, successfully develop high quality, commercially viable processes, spanning from pre-clinical development through commercial scale manufacturing.

Two Decades, One Focus: Sterile Manufacturing Excellence

Discover expert aseptic manufacturing with flexible batch sizes, regulatory excellence, and end-to-end support, specializing in sterile injectable solutions for clinical and commercial 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.

Connect With Outsourced Pharma: