Newsletter | March 26, 2026

03.26.26 -- The Jones Act Hurts U.S. Pharmaceutical Manufacturing

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Webinar: Less Risk, More Speed -The New Blueprint for Bioconjugate Development: A Fireside Chat

Bioconjugate development is evolving fast. In this Abzena fireside chat, discover how an integrated CDMO+CRO model reduces risk, removes roadblocks, and accelerates timelines for ADCs and emerging modalities. Gain practical playbooks, partner selection strategies, and fast-track frameworks to move from discovery to GMP with confidence, consistency, and speed without sacrificing quality or control. Click here to learn more.

INDUSTRY INSIGHTS

Scaling For What's Next In EMEA

Scaling cell and gene therapy operations in EMEA demands strategic planning, regulatory alignment, and robust logistics to meet growing demand and ensure consistent delivery across diverse markets.

EU Annex 1: Building Modern CDMO Sterile Fill/Finish Facilities

A CDMO guide to implementing EU Annex 1 for modern sterile fill/finish facilities, covering cleanroom design, contamination control, utilities, personnel, monitoring, and audit essentials.

A CRDO Path To Faster Biologic Development

A science‑driven CRDO model accelerates biologic development by combining expert formulation, analytics, and partnerships to reduce risk and improve outcomes.

FEATURED EDITORIAL

The Jones Act Hurts U.S. Pharmaceutical Manufacturing

The Jones Act punishes U.S. pharmaceutical manufacturing. It may have taken a modern-day war, one much involved with the free navigation of commercial shipping, but after more than 100 years navigating a policy of protectionism – and fear of competition – we have again waived the Jones Act (for 60 days). Chief Editor Louis Garguilo says let’s not temporarily waive it. Sink the Jones Act forever.

SUS Interchangeability Assessment And Qualification Best Practices

Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

INDUSTRY INSIGHTS CONTINUED

Sterile Filling Readiness In The Drug Device Delivery Ecosystem

Explore how adaptable technologies and strategic partnerships help navigate Annex 1 compliance and technical hurdles to ensure the successful delivery of complex drug products.

The Gateway Delivery To The Brain

Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

Keys To Achieving Unparalleled Flexibility In CHO Based Bioproduction

The dynamic growth and pace of change observed in novel mAb formats and cell and gene therapies emphasizes that biomanufacturing innovation is essential to deliver scale, speed, and sustainability.

The Difficulties Of Working With Multiple Siloed Partners

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Transitioning To PFS And Subcutaneous Delivery

Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

Soluble Versus Insoluble Expression In Microbial Fermentation

Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

SOLUTIONS

Made For What's Next In Drug Delivery

A global partner offering prefillable drug‑delivery systems, manufacturing expertise, and integrated services that accelerate development, secure supply, and support therapies across multiple areas.

Reliable Aseptic Filling For Your Patients

Specialist in Aseptic Fill-Finish and packaging of Cartridges, pre-filled syringes (PFS) and vials.

Integrated ADC Offering: From Concept To Commercialization

Leveraging deep ADC expertise and experience, successfully develop high quality, commercially viable processes, spanning from pre-clinical development through commercial scale manufacturing.

Accelerate Your Pipeline With CDMO Collaboration

A CDMO can augment your capacity and expertise, refine your processes, and ultimately shorten your time to market. Explore best practices that make working with a CDMO as efficient as possible.

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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