Newsletter | July 25, 2025

07.25.25 -- Why CDMOs Are Leaving Small Molecules Behind

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INDUSTRY INSIGHTS

Driving Success Beyond Project Boundaries

The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.

Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations

Review a study designed to investigate CCI over 24 months at ambient, ultra-low, and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

Particle Size Control Through Micronization: Challenges And Solutions

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

FEATURED EDITORIAL

Why CDMOs Are Leaving Small Molecules Behind

It’s rare when a CDMO’s restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus heavily on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.

 

Optimizing Operational Excellence In Pharma And Medical Devices

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

INDUSTRY INSIGHTS CONTINUED

An Emerging Alternative

Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

Innovations In Pregastric Absorption Drug Delivery And ODTs

Experts explore permeation enhancers for drug absorption, PBPK modeling for formulation design, and fast-dissolving ODTs shaping drug development.

ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

Leverage advanced testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

SOLUTIONS

Fine Chemical Manufacturing Services: R&D From Concept To Commercial

We offer comprehensive research and development services that are equipped to handle all your product development needs, bringing your projects from concept to production.

Cleanroom Collaboration

Learn how speed and flexibility can help your organization enhance your drug product, from clinical to commercial, with our high-performing cleanroom facility and filling technology.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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