Newsletter | August 25, 2026

08.25.26 -- Pharma Outsourcing Is Evolving. Cold Chain Monitoring Shows Why

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Webinar: From IND To Commercial Reality: Scaling Cell And Gene Therapy Manufacturing

What does it take to move a cell and gene therapy from development to commercial supply? Join us for a practical conversation on evolving CMC strategies, choosing the right commercialization partner, reducing batch costs, and navigating regulatory challenges. We’ll explore hidden inefficiencies, when to challenge conventional approaches, and how proactive lifecycle planning supports successful commercialization. Click here to learn more.

INDUSTRY INSIGHTS

Collaborative Variability Reduction In Cell Culture Media

Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

Speeding Up Safety: An Evaluation Of Mycoplasma Technology

Rapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering reliable contamination detection across diverse matrices.

The Importance Of Quality In Raw Material Selection

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

FEATURED EDITORIAL

Pharma Outsourcing Is Evolving. Cold Chain Monitoring Shows Why

Chief Editor Louis Garguilo superimposes two reports: one on a precise subject, cold chain monitoring; the second an analysis of the entire contract manufacturing market.  What brings the two together? "Growth, its various components, and interpretations." The cold chain monitoring report is prime example of the components of growth demonstrated in the overall biopharma outsourcing market report.

Don't Let Your CDMO Define Quality for You

Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.

Six Critical Decisions That Shape Oligonucleotide Scale-Up Success

From impurity control to technology transfer governance, these practical lessons will help sponsors navigate the realities of oligonucleotide manufacturing scale-up.

INDUSTRY INSIGHTS CONTINUED

Achieving Cell Therapy Success: Reducing Costs To Improve Patient Access

To ensure the commercial success of cell therapies, developers must adopt innovative manufacturing and QC technologies that reduce COGS while enhancing scalability, quality, and clinical outcomes.

How Data-Driven Development Is Transforming Phosphoramidites

High-quality phosphoramidites are key to oligonucleotide therapies. Learn how data-driven optimization boosts purity, streamlines manufacturing, speeds scale-up, and supports commercialization.

Accelerate Efficiency By Decoupling Collection From Manufacturing

Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.

The Critical Bottleneck In Personalized Cancer Vaccines

Personalized cancer vaccines face a DNA production bottleneck. Synthetic approaches speed timelines, boost consistency, and simplify workflows to deliver individualized therapies faster.

CDMOs Evolve IT Validation Strategies To Stay Ahead

CDMOs are modernizing IT validation by adopting risk-based, lifecycle approaches, digital tools, and continuous assurance models to improve compliance, efficiency, scalability, and data integrity.

A Smarter Strategy For Higher AAV Yields

Low AAV productivity and a lack of platform processes continue to be challenges driving AAV production costs up. Explore a robust and scalable suspension manufacturing platform for AAV production.

Automated T-Cell Manufacturing At Scale

Uncover an automated, closed cell‑therapy manufacturing system that boosts consistency, scalability, and quality while addressing donor variability and optimizing key process and performance parameters.

What Sponsors Get Wrong When Selecting A CRO

Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.

Making A Meaningful Impact In AAV

View highlights of in-house plasmid manufacturing, expanded commercialization development, and cost reduction in gene therapy manufacturing.

xRNA Production: The Economic Case For Continuous Manufacturing

See how a continuous manufacturing platform streamlines production to days, uses real-time quality control, and dramatically cuts costs to accelerate access to new therapies.

Time: A Crucial Factor In Therapeutics Development

Accelerate your mRNA development and strengthen your response to emerging health threats with next-generation, cell-free DNA template solutions designed for speed, quality, and reliability.

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Cell 2026 | 12-13 November, London, UK

Advanced therapy development moves fast, and the companies shaping it are the ones connecting science, scale and strategy in the same room. Cell 2026 is where that happens. Partner with us to reach 800+ senior pharma, biotech and R&D decision-makers through guaranteed 1:1 meetings, speaking slots, roundtables and tailored digital campaigns. Get in touch and we'll design a package around your objectives.

SOLUTIONS

Viral Vector CDMO Services

A Faster Path To IND-Ready CAR-T Manufacturing

Biologics Discovery Service: From Target To Preclinical Candidates

iPSC Differentiated Cell Products

Accelerating Biologics From DNA To Patient

The Future Of Lentiviral Vector Innovation And Access

Cell Sourcing

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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