Newsletter | December 23, 2025

12.23.25 -- You're In Charge Of Strategic Sourcing? What's That Actually Mean?

INDUSTRY INSIGHTS

What Are The Keys To Making Rare Disease Drug Development Sustainable?

This roundtable weaves together diverse perspectives, providing a multifaceted look at what it will take to create a sustainable path forward in rare disease drug development.

Accelerate Your pDNA And mRNA Process Development

Explore a structured approach to optimizing and scaling plasmid DNA production using E. coli, with insights into key growth parameters, benchtop feasibility, and pilot-scale performance.

Part Two: Overcoming Limits In LVV Titer Measurement

Learn how a platform streamlines LVV titer measurement, offering a faster and more efficient alternative to traditional methods and addressing key process development challenges.

FEATURED EDITORIAL

You're In Charge Of Strategic Sourcing? What's That Actually Mean?

Here, I wrap up my investigation into the real meaning of "strategic" when it comes to supply chains, sourcing, procurement, and outsourcing development and manufacturing to CDMOs. Check out this series of best practices that turn one-off tactics and isolated decisions into multi-variable and thoughtfully aligned relationships.

Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up

Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

INDUSTRY INSIGHTS CONTINUED

The Crucial Role Of Apheresis In Cellular Therapies

Focusing on quality, the presenters will discuss the importance of adhering to collection protocols and the real-world effects on treatment outcomes.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered TARGATT™ landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Utilizing Multiplex ddPCR To Streamline Viral Gene Therapy Workflows

Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development.

Scaling Up Your E. Coli pDNA Process From Parameter Screening To Pilot Scale

Discover a systematic approach to scalable plasmid DNA production using E. coli OneShot Top10, which features DOE-driven optimization and key insights for efficient biomanufacturing success.

Challenges And Solutions For Viral Product Development, Manufacturing

To execute complex viral product manufacturing, a service provider needs expertise in adherent cell culture capabilities, cell line productivity, and the intricacies associated with these products.

Taking A Look At AAV Production Using HEK293 In A Perfusion Process

A unique, scalable, and cost-effective approach to generating AAV viral vectors leverages a high-performing cell line, optimized reagents, and purpose-built technology.

Predictive Features Of Apheresis In Gamma Delta T Cell Therapy

Improved iPBMC manufacturing boosts TIL therapy reliability, safety, and affordability through donor screening, process refinements, and performance-based cell selection.

Development Strategies For Adenovirus-Based Gene Therapies

Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

Path To IND: AAV Transient Transfection, Producer Cell Line Platforms

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

SOLUTIONS

Your CDMO Partner From CMC Development To Commercial Supply

Consider a platform that offers clients a personalized, responsive, and expert-driven approach to process development and manufacturing from early clinical to pivotal supply and commercial launch.

Chain Of Compliance: Enabling A Significantly Smarter Supply Chain

Strengthen your precision medicine strategy by ensuring end-to-end traceability and preparing for the emerging fourth link in regenerative medicine’s chain to meet evolving quality and regulatory demands.

Pharmaceutical Labeling Systems For Vials

Vial labeling demands precise, high-speed labeling systems to ensure accurate and reliable product identification, particularly in the pharmaceutical industry where safety and compliance are paramount.

Biopharmaceutical Process And Manufacturing Technology Services

Critical to a streamlined process is robust process change management with targeted assessments giving you the desired outcome to reduce deviations, lower cost, and enhance strategy.

Capabilities Update October 2025: Fill/Finish

Our experts and investment in state-of-the-art development and manufacturing facilities underscore our commitment to advancing programs from the clinic to commercialization.

Capabilities Update October 2025: Cell & Gene Therapy

During this session, we will provide an overview of our capabilities, including our contract testing services, and an update on our current capacity.

Stand-Alone Fill-Finish Service Offering

Review our technical capabilities and specifications and discover how a partner with fill-finish services designed to take advantage of 100% of the product can guide your product to commercial success.

Revolutionary Enzyme Engineered To Overcome RNA Hurdles

Codex® HiCap RNA Polymerase delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

Advanced iPSC Workflows: Accelerating Cell Therapy Development

Beyond offering our GMP-compliant iPS cells, we develop superior workflows for gene editing and differentiation to provide competitive platforms to our partners and accelerate their therapeutic programs.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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