Newsletter | April 24, 2025

04.24.25 -- Are You Ready For 2025's Outsourcing Shift?

SPONSOR

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

INDUSTRY INSIGHTS

Treating Deficiencies In Employee Training And Mentorship

Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

Essential Considerations For Selecting The Right Biologic Fill/Finish Partner

Partnering with a provider that prioritizes quality and yield optimization not only ensures product safety but also helps reduce operational costs.

Potency Assays 101: How To Develop A CMC Relative Potency Assay

Here, we dissect the potency assay development process into its key steps, offering a clearer understanding of the journey.

FEATURED EDITORIAL

CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

Facility investments by CDMOs continue to be magnetized to Asia. Recent examples abound. Chief Editor Louis Garguilo details some of those, and discusses whether, for example, a President Trump-intensified focus on increasing manufacturing in the U.S. can change this. Will your outsourcing in 2025 change direction? The answer may surprise you.

The Strategic Role Of Cost Modeling In Pharmaceutical Procurement

Selecting a CDMO depends on price, geography, expertise, and other variables. While price is often a key motivation for the decision, production cost should be carefully considered. See how an independent analysis can be very helpful in making the right decision.

INDUSTRY INSIGHTS CONTINUED

Protect Patients, Ensure Regulatory Compliance With Impurity Control

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

Best Practices In Formulation, Lyophilization Development: Proteins, mAbs, ADCs

Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

Enabling Digital Twins With Computational Fluid Dynamics Modeling

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.

Cis-Targeted Immunotherapies Need Large CDMO Expertise And Flexibility

Asher Biotherapeutics was seeking a CDMO that could handle Phase 2 through to commercial production, as well as taking early-stage projects in its pipeline all the way through their lifecycle.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

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

Navigating The Full Biologic Drug Development Lifecycle

This interview addresses attendees' questions from a recent webinar about a new biomanufacturing site in Waltham, MA, equipped with state-of-the-art equipment.

SOLUTIONS

Capacity Update October 2024: Fill/Finish

Consider our high-quality GMP manufacturing capabilities, featuring a state-of-the-art isolator-based filling platform and extensive fill-finish capacity for vials, syringes, and cartridges.

Biologics Technology Transfer Guidebook

This guide outlines essential strategies, best practices, and key considerations, highlighting why technology transfer is a vital pillar of mammalian biologic drug development and manufacturing.

GS Effex Cell Line For Enhanced Antibody Effector Function

GS Effex has been engineered to lack the enzyme responsible for the addition of fucose, α1,6-fucosyltransferase. This industrially relevant cell line produces antibodies free of fucose.

Process Development CDMO Services

Partner with us for fully customized, cGMP-enabling R&D services designed to accelerate your biologic from concept to commercialization.

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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