Newsletter | March 18, 2026

03.18.26 -- A Biotech Business Model That's Investor-Friendly

INDUSTRY INSIGHTS

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

Right From The Start: Smarter Developability For Stronger Formulations

Early developability assessment integrates manufacturability, QbD, flexible formulations, and CDMO support to cut risk, speed development, and enable scalable, robust drugs.

Ensuring The Compliant Manufacture Of Highly Potent Drug Products

Examine the intricacies of manufacturing highly potent APIs and associated drug products to ensure compliance with GMP regulations.

FEATURED EDITORIAL

A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

5 QMS Blind Spots You Should Know About

Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

INDUSTRY INSIGHTS CONTINUED

Silencing CDMO Project Noise: The Power Of Low-Drama Drug Development

Move beyond reactive firefighting by prioritizing disciplined leadership and data-driven milestones. The winning model for complex programs is focused, high-maturity, low-drama execution.

Advancing Drug Development Using In Silico Modeling

Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.

Three Considerations For New Drug Developers

The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside.

Expertise And Transparency Drive A Distinct Development Journey

Coordinated expertise, real‑time visibility, and clear communication support smoother development, manufacturing, and clinical supply. Strong alignment improves predictability and lowers risk.

The Principles Of Green Chemistry: Reduce Derivatives

Design synthetic routes to minimize or eliminate unnecessary temporary blocking groups. This reduces reagent use, yield loss, and waste generation, improving overall process efficiency.

A Proven Approach To Impurity Control Across API And RSM Synthesis

To help manage impurities and mitigate risk across all stages of development, consider the benefits of working with a CDMO that has robust chemistry understanding and manufacturing experience.

SOLUTIONS

Advances In Sterile Fill‑Finish Innovation

Patricia Krainski highlights the global sterile fill‑finish and lyophilization strengths, showcasing investments that expand capacity, technologies, and integrated solutions.

Expediting Drug Discovery From Concept To Commercialization

See a suite of services designed to accelerate discovery and development, from custom reagent production and high-throughput screening to advanced in vitro pharmacology and DMPK assays.

Trust Our Experience

With extensive experience in delivery R&D, development, and manufacturing, we've advanced particle-engineered platforms and supported many improved drug products.

Site Capabilities Overview

Backed by strong regulatory expertise and a track record of global inspections, our site delivers reliable, compliant solutions for pharmaceutical partners seeking end-to-end support.

Progesterone Made With Green Science

This first-of-its-kind progesterone synthesis significantly reduces environmental impact by cutting the carbon footprint by over 70% compared to traditional methods.

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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