Newsletter | June 16, 2025

06.16.25 -- Tariffs On Toys … And API? Biopharma As The Next Battleground

SPONSOR

Advance Biotech Grant – Applications Now Open!

Our EMEA Advance Biotech Grant Program is open for European biotech startup companies to help them accelerate to clinic faster. Enter for a chance to win €148,400 in products & services here.

INDUSTRY INSIGHTS

Unlocking The Benefits Of FTZ Subzones For Pharmaceutical Manufacturing

Explore how a contract manufacturer that is approved as a certified FTZ subzone can help sponsor companies unlock significant benefits and gain a competitive edge in the global pharmaceutical industry.

Identifying New, Enhanced Device Delivery Solutions For Chronic Diseases

Needle innovations, including the usage of shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes, which enhances the end-user experience.

Reducing Time To First-In-Human Trials

Discover how robotic gloveless isolator sterile fill-finish systems (SFF) can accelerate early-phase drug development, ensuring enhanced sterility and streamlined processes for biopharma innovation.

FEATURED EDITORIAL

Tariffs On Toys … And API? Biopharma As The Next Battleground

Outsourcing drug development and manufacturing is an attempt at purposeful action in a web of interdependent contingencies. The contingency top-of-mind today is President Trump’s tariff strategy, and global "negotiations" that have ushered in a supply-chain disquietude.

Common Reasons For IND Rejections

Jumai Abioye, Pan Access Innovations, and Bikash Chatterjee, Pharmatech Associates, lay out for Outsourced Pharma readers the most common issues with IND submissions.

INDUSTRY INSIGHTS CONTINUED

Streamlining Development: Advantages 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.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

5 Things To Know About The FDA's Shift From Animal Testing

Learn how embracing advanced computational and human-relevant testing methods can transform your drug development process and accelerate your path to clinical success.

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

Examine 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.

Identification And Quantification Of Host Cell Proteins

UHPLC-MS is now widely used in pharma, enabling efficient HCP identification and quantification through an implementation-based approach.

Antibody-Drug Conjugates: Manufacturing Precision Medicines

Ensure the integrity and performance of your mAb intermediate by adhering to strict storage and handling protocols that safeguard its critical attributes for successful conjugation.

SPONSOR

Webinar: Transposase-Enabled CLD: From Transfection to High Titer with Ease

Join KBI Biopharma for a webinar on transposase-enabled cell line development. Built on Selexis® SUREtechnology™ and CHO-M™, this platform delivers high titers, rapid development, and stability for complex biologics. Learn how it accelerates timelines, supports diverse molecule formats, and meets regulatory demands—offering a scalable, efficient alternative to traditional CLD methods. Perfect for teams seeking speed, quality, and flexibility in biotherapeutic development. Click here to learn more.

SOLUTIONS

How Can Change Control Help Your Organization?

Streamline your entire change control process and simplify validation with MasterControl Change Control™ and our scalable validation solutions tailored for FDA-regulated environments.

Trusted End-To-End CDMO Partner For Your Journey

In an increasingly competitive environment, working with the right CDMO is vital for successful drug lifecycle management. 

Capacity Update April 2025: Fill/Finish

This presentation highlights how simplified execution with development, filling, and analytics under one roof ensures safe, efficacious products reach patients in need.

Microbial Platform For Protein Expression

Establish productive, robust, scalable, and efficient cGMP processes more quickly and easily with the XS Technologies platform which offers a toolbox of system components.

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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