Newsletter | June 2, 2025

06.02.25 -- STREAM Edition: Evolve Or Fade Away? Biotech's Outsourcing Moment In Trump's Tariff Tangle

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Webinar: Building Better Biologics: Early strategies for optimizing the progression of biotherapeutic candidates to first in human studies and beyond

Explore how leveraging the right technologies and strategies early in development can help to optimize candidate selection, aid progression to cell line development, enhance manufacturability, and reduce downstream risk. We highlight common pitfalls and provide actionable strategies to accelerate the translation of biologic candidates from late discovery to first-in-human studies. Click here to learn more.

INDUSTRY INSIGHTS

TMT Labeling For Optimized Sample Preparation In Quantitative Proteomics

Leverage the power of Tandem Mass Tags (TMT) quantitative proteomics to gain deep insights into cellular dynamics, disease mechanisms, and drug targeting.

Essential Insights Into Pharmaceutical Product Release: Part 1

Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical process essential for FDA approval and patient safety.

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

Review a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

FEATURED EDITORIAL

Evolve Or Fade Away? Biotech's Outsourcing Moment In Trump's Tariff Tangle

Ali Pashazadeh is "a deep thinker" that our chief editor visits with annually. Recently, he asked Pashazadeh to help us contemplate the evolving policies of the new U.S. presidential administration and the tariff turbulence, as they relate to outsourcing in biotech.

 

ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy

Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

INDUSTRY INSIGHTS CONTINUED

Accelerating Novel Therapies To The Market

Formulations require flexibility to support adaptive sterile manufacturing and an integrated approach for a path from development, to small batch manufacturing, to commercialization.

Support Of Scale-Up And Technical Transfer Through Understanding Equipment

See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

Optimizing Analytical Strategies Throughout The Biologics Development Lifecycle

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

Packing MabSelect And MabSelect SuRe Resins Using Verified Methods

Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods promote stability, optimal flow, and reproducibility across scales using automated tools.

How Platform Technologies Power Up Processes From Lab To cGMP

This discussion among experts examines ways to push the envelope of expression system technology and process characterization while maximizing user transparency.

Driving Innovation And Sustainability In China’s Healthcare Ecosystem

Discover how a long-standing global innovator is advancing healthcare, sustainability, and economic progress across China through integrated R&D, manufacturing, and local partnerships.

SOLUTIONS

The Next-Gen Cell Line Development Platform Fueling Biologics Success

Whether you're navigating the challenges of complex biologics or seeking a faster path to the clinic, this discussion sheds light on how innovation in CLD can be a game-changer for your pipeline.

Capacity Update April 2025: Fill/Finish

Tara Lorenz, Sr. Director of Commercial Operations, speaks on our latest investments and expanded fill/finish capabilities and capacity for small molecules, biologics, and other sterile injectable products.

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

With mounting pressure to accelerate timelines, choosing a CDMO that boosts capacity and streamlines processes through innovation is key to maintaining quality.

Our Biotech Success — Levicept

Simon Westbrook formed Levicept to develop an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.

Commercial/Clinical cGMP Quality Control Analysis

We implement a system-wide QbD approach to different phases of a clinical or drug product, including raw materials, in-process, batch release, and stability / shelf-life evaluation.

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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