Newsletter | July 28, 2026

07.28.26 -- The Curious Route Back To The In-Person Conference

INDUSTRY INSIGHTS

Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1?

Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge.

Yeast Extracts: Improving Expression

Yeast extract improves E. coli protein production by over 50%, boosts desired protein attributes 4X, and offers a secure animal-free nutrient source.

Accelerating CGT Development And Manufacturing

Learn how the following framework can accelerate your viral vector, CAR-T, and iPSC programs, reduce risk, and streamline your path from development to commercial manufacturing.

FEATURED EDITORIAL

The Curious Route Back To The In-Person Conference

We've acquired one of the industry's fastest-growing outsourcing conference franchises. We’re back in the live events business; that's great news. This new partnership also sets us to wondering: As an outsourcing industry, where in fact are we regarding in-person and virtual events? I asked my new colleagues, the co-founders of PharmaSource and CDMO Live conferences, Luke Bilton and Chris Kilbee.

Let's Stop Treating Allogeneic Cell Therapy As One Thing

Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

Kodak's CEO Leans Into Biopharma Manufacturing – "I'm An Operator"

Kodak’s Eastman Business Park in Rochester was the focus of a recent editorial. But the man leading Kodak’s comeback, Jim Continenza, Chairman and CEO, is a topic unto himself. He’s as animated as any public-company CEO you’ll encounter. And he knows his audience; in his conversation with Chief Editor Louis Garguilo he says Kodak “has always supplied CDMOs and the industry with important chemicals.” Read his vigorous take on domestic manufacturing and other supply-chain topics.

INDUSTRY INSIGHTS CONTINUED

GMP Manufacturing Cycle Time Reduction

Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

How In-House CDMO Analytics Reduce Risk and Cost

Integrated analytical capabilities within a CDMO are increasingly preferred to overcome challenges associated with outsourcing analysis in biopharma development and manufacturing.

mRNA Vaccines And Therapeutics: Current Trends And Perspectives

Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.

High‑Throughput Automation For Consistent Expression

A high‑throughput, automated RNA‑seq workflow maintains uniform gene‑expression profiles across wide RNA inputs, enabling consistent library quality and genomics on standard liquid‑handling platforms.

Why ddPCR Is Becoming The Standard For Gene Therapy Biodistribution

ddPCR is becoming essential for biodistribution because it delivers precise, low‑copy quantification qPCR can’t reliably match. Sponsors need partners with true ddPCR depth to ensure defensible data.

Quality Agreements, Tech Transfer & Risk Management In CGT

Early quality, strong tech transfer, solid data discipline, and risk‑based decisions help accelerate advanced therapy programs and ensure compliance, scalability, and regulatory confidence.

Solving The DNA Knock-In Problem

An in‑depth exploration of why large, precise DNA knock‑ins limit cell therapy progress—and how site‑specific integration enables durable, scalable genetic engineering solutions.

Strategic Supply Chain Leadership: Driving Biopharma Growth

Amid a volatile pharma supply chain, strategic sourcing is now critical. Prioritizing your raw material supply ensures operational continuity, consistent performance, compliance, and on-time delivery.

Challenges And Opportunities With Novel AAV Capsids

Explore challenges and solutions in developing novel AAV capsids, focusing on manufacturing complexity, analytical testing, and regulatory considerations for advancing gene therapy effectiveness.

Navigating Intensifying Cell Therapy Regulatory Expectations

Rising regulatory demands require strong CMC, validated analytics, and inspection-ready operations. Early alignment of quality, scalability, and risk management is key to cell therapy commercialization.

SOLUTIONS

A Smarter Lentiviral Vector Design

Accelerating Advanced Therapies In Cell & Gene Manufacturing

Oligonucleotides LC-MS: Support From Development To Release

From Design To Operation: Supporting GMP Facility Readiness

Cryopreservation Services

Partnering With You From Preclinical Through Commercial Scale

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.

Connect With Outsourced Pharma: