Newsletter | April 6, 2026

04.06.26 -- In Palm Beach The Focus Is On Biotech (Not President Trump)

SPONSOR

Webinar: From DNA to IND in as little as 6 months: Fast to clinic, designed to scale, backed by experience

Accelerating antibody development requires smarter strategy. In this webinar, Lonza explores how an integrated CMC approach can move programs from DNA to IND in as little as six months. Learn how platform technologies, parallel workflows, and CDMO collaboration reduce risk, avoid bottlenecks, and support faster biologics development. Click here to learn more.

INDUSTRY INSIGHTS

3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

Collaborate For Standardization In Large-Volume Subcutaneous Delivery

Establishing unified component standards through collaborative innovation eliminates unnecessary investment, reduces development timelines, and ensures scalable, patient-centered delivery systems.

Protect Patients, Ensure Regulatory Compliance With Impurity Control

A sponsor’s commitment to impurity control throughout manufacturing is vital to ensuring continuous patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.

FEATURED EDITORIAL

In Palm Beach The Focus Is On Biotech (Not President Trump)

“When I came to Florida,” James Sapirstein says, “I was leaving New Jersey because of tax reasons.” That was 2018. Timing is everything, they say. Sapirstein’s relocation placed him ahead of a broadening and intensifying migration trend – including he believes, a new biotechnology settlement. This is not news to readers – Miami alone seems perennially in the headlines. “Economics drives investors,” Sapirstein says, and Sapirstein is committed spearheading “a new kind of biotech cluster."

UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

INDUSTRY INSIGHTS CONTINUED

Trends In Mid-Size Scale Up Strategies

A development leader highlights supply‑chain resilience, cost‑efficient large‑scale manufacturing, proven tech‑transfer success, and long‑term commitment to supporting clients through production strategies.

Raising The Bar For Large‑Molecule Development

How a seasoned development and manufacturing team blends technical depth, reliability, and flexible support to advance large‑molecule programs amid shifting timelines, costs, and regulatory demands.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

See strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

Patented Process For Intermediates Useful For Deucravacitinib

Discover how this patented synthetic approach to Deucravacitinib intermediates can improve yield, simplify purification, and support scalable, regulatory-aligned manufacturing.

Getting Your Proof Of Clonality Right For Regulators

Regulators require clear, verifiable proof that production cell lines originate from a single progenitor cell, supported by imaging, documentation, and data integrity to ensure product consistency and safety.

Beyond The Booth: Shaping The Future Of Pharma Partnerships

Navigating the pharma landscape requires resilient regional supply chains, integrated partnerships, and practical AI to drive stability and innovation.

The Future Of RNA Manufacturing Starts With Raw Material Innovation

Amid the mRNA and oligonucleotide therapeutic boom, manufacturers are exploring how to make critical raw materials—capping agents, lipid nanoparticles, and RNA polymerase—more effective.

SPONSOR

Outsourced Pharma Capabilities Update

This online event series connects biopharma companies with CDMOs to explore capabilities across biologics production, HPAPI manufacturing, and drug–device combination development. Through concise presentations, CDMOs showcase expertise in development, scale-up, containment, and GMP manufacturing. Attendees gain insights into technologies, regulatory expectations, and partnership models, while engaging directly with providers to evaluate outsourcing options and identify the best-fit partners for advancing and commercializing complex therapies. Click to learn more.

SOLUTIONS

An Integrated, Verified PFS System For Vaccines

A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.

Mammalian Protein Development And Manufacturing

With proven expertise in process development, optimization, and CGMP manufacturing, Avid offers end-to-end CDMO solutions backed by flexible capacity designed to scale with program needs.

Services Designed To Take You From Molecule To Market

Accelerate your biopharma journey with a comprehensive service portfolio designed to speed development, reduce costs, and minimize risk from molecule to market.

Cell Line For Enhanced Antibody Effector Function

This cell line has been engineered to lack the enzyme α1,6‑fucosyltransferase, which is responsible for fucose addition, enabling the production of antibodies that are free of fucose.

Biologics Development

We offer industry‑leading biologics development services, supporting global clients across all clinical phases and regulatory pathways, including process and formulation development.

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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