Newsletter | June 16, 2026

06.16.26 -- Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation?

INDUSTRY INSIGHTS

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Leveraging Technology For Rapid Clinical Material Delivery

Discover how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

FEATURED EDITORIAL

Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation?

Investment manager BlackRock gathered powerful investors to discuss along with government officials the nation’s physical and economic backbone. The Infrastructure Summit clarified the biopharma industry including CDMOs are in a battle for investments and infrastructure. Analysis from Chief Editor Louis Garguilo.

A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

Does Biotech Need More Government Funding — Or A New Business Model?

Should government financing appreciably recede – whether through policy shifts, budget pressures, or ideological bent – what would happen to the biotech business model? To ascertain such a question, first we must look at the fundamentals of the existing model and then understand investors (and service providers) better.

INDUSTRY INSIGHTS CONTINUED

AAV Upstream Process Development: High-Throughput To Clinical Scale

AAV manufacturing costs can exceed $1M per dose. See how DoE in a high-throughput system cut COGs by 60% and scaled AAV9 production to 2,000 L.

Building On Pittsburgh's Legacy To Industrialize Advanced Therapies

Pittsburgh's industrial roots and growing biotech hub unite to scale advanced therapies through new purpose‑built biomanufacturing, automation, and workforce development.

Translating Stem Cell Programs To GMP

A detailed exploration of challenges in advancing stem cell programs to GMP, highlighting strategies to control variability, strengthen process design, and support reliable clinical‑stage manufacturing.

Powering Cell Therapy Access: Louisville, KY's Unique Position

Uncover why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

Capital Constraints In CDMO & Pharma M&A

Capital constraints are reshaping CDMO and pharma strategies, driving selective M&A, prioritizing partnerships, and enforcing financial discipline amid tighter investment conditions.

Unlocking The Next Wave Of Cancer Vaccines

Assimilate how advanced ionizable LNP formulations and scalable manufacturing strategies can accelerate the development and clinical translation of personalized cancer vaccines.

SOLUTIONS

Custom Circles In Gene Editing

Simplify Your mRNA Workflow From The Start

Advancing Innovative Plasmid DNA Manufacturing Solutions For CGT

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services

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