Newsletter | March 25, 2026

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

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Join us for two Outsourced Pharma Capabilities Update sessions featuring leading CDMOs sharing their facilities, timelines, and available capacity for development and manufacturing. The April 21st session focuses on small molecule drug product capabilities, while April 22nd highlights fill-finish technologies including sterile filling, lyophilization, and advanced packaging. Expect short digital presentations to help biopharma companies identify partners that can meet their manufacturing needs. Click to learn more.

INDUSTRY INSIGHTS

Polymer Screening And Case Study Insights

Discover how early polymer selection drives formulation success, with case studies linking polymer choice to drug release and practical insights for developing robust CR products.

The Crucial Role Of Project Managers In Selecting A CDMO Partner

Leverage the expertise of experienced project managers to select the right CDMO partner, mitigate risk, and drive your pharmaceutical program toward faster, more successful outcomes.

The Fusion-Based, Solvent-Free Process Disrupting Spray Drying

Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.

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.

Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

INDUSTRY INSIGHTS CONTINUED

Innovative Softgel Technologies To Deliver Poorly Soluble Molecules

Learn how to expedite the development pathway for early phase compounds and how lipid based formulations provide an innovative approach to enhance bioavailability for challenging molecules.

Navigating Nitrosamine Impurities In Pharmaceutical Drug Development

Understanding formation mechanisms and potency categorization allows developers to mitigate risks early, ensuring regulatory compliance and patient safety without compromising product performance.

How High Drug Load Nanocrystalline Tablets Lower Pill Burden

We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.

Advancing ADCs With Expertise In Payloads And Linkers

Assimilate how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program.

Innovative AI-Driven Solutions To Address The Growing Complexity Of APIs

Computer-aided synthesis planning (CASP) can mitigate the impact of rising complexity. Here, we discuss the award-winning AI and vast data that propel a leading predictive retrosynthesis technology.

Spray Drying For Improved Solubility

Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

Corticosteroids And Hormonal Therapies — History, Use, And Future Outlook

Explore how evolving science, expanding global demand, and next-generation innovations are reshaping the future of corticosteroid and hormonal therapies — and what this transformation means for the future.

SOLUTIONS

R&D Pipeline Overview

This pipeline covers late-stage and emerging therapies projected for 2024-2031 across immunology, neurology, psychiatry, rare disease, oncology, and inflammatory conditions.

Process Development And Preclinical Manufacturing — India

This network currently spans across 9 manufacturing sites in 5 countries and can support discovery, preclinical, clinical and commercial programs for New Chemical Entities (NCEs).

Comprehensive GMP Testing Services

We deliver global GMP testing with 45+ facilities, ensuring regulatory acceptance, quality, and trusted service from starting materials to finished products.

Expertise In Solid Oral Dose Contract Manufacturing And Packaging

See a solution with nearly 50 years of excellence in solid oral dose manufacturing and packaging that has innovative facilities and skilled professionals to deliver trusted products worldwide.

Label Translation Solution

By simplifying label requests, integrating expert translation and regulatory support, and enabling a fully paperless approval workflow, organizations can reduce turnaround times..

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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