Newsletter | November 14, 2025

11.14.25 -- Is Passion A Criteria For Your CDMO Selection?

SPONSOR

Looking for a U.S. based CRO or CDMO? Curia’s 10 U.S. facilities and 30+ year track record can support your small molecule or biologic from curiosity to cure. Whether you’re a small startup with a big idea or an established sponsor seeking additional capacity, Curia can support your discovery, development, or manufacturing needs. Learn more.

INDUSTRY INSIGHTS

How To Increase Success In Topical Drug Development With Automation

Automation is a valuable tool for enhancing topical formulation development and reducing the risk of failure, thus improving topical drug success, from pre-formulation to performance testing.

Getting To The Heart Of CDMO Tech Transfer Excellence

Uncover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success.

Understanding Nitrosamines: Key Regulations And Best Practices

This presentation will equip attendees with practical knowledge and actionable insights to navigate the complexities of nitrosamine regulations, ensuring compliance and safeguarding product integrity.

FEATURED EDITORIAL

Is Passion A Criteria For Your CDMO Selection?

With a tinge of trepidation at being thought of as whimsical, I asked our Editorial Advisory Board: Can consideration of a CDMO’s passion play a role in due diligence for selecting a partner? Is there a qualifiable measurement (intuition?) related to a CDMO’s enthusiasm? I was surprised (and relieved) by the, well, passion with which some Board members replied. Here's what they think.

Process Validation: Harmonization Of Terms Used To Identify Validation Lots

The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

INDUSTRY INSIGHTS CONTINUED

Highly Potent API Product Development, Manufacturing Using Micronization

As demand grows, the need for advanced safety measures and reliable manufacturing technologies becomes critical, underscoring the importance of partnering with an experienced HPAPI manufacturer.

A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

Strategic Resource Optimization For Bio-Pharma Operations

Achieve greater agility and resilience in biopharma operations by implementing strategic resource optimization, which can generate millions in savings by reducing waste and maximizing asset value.

Solutions For Accelerated Pharmaceutical Development

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

SOLUTIONS

Cambrex Scientist Spotlight: Luigi Bellone

Luigi Bellone, Head of Quality Assurance in Paullo, Milan, brings over 20 years of experience in quality assurance (QA), quality control (QC), and regulatory compliance within the pharmaceutical industry.

Capabilities Update October 2025: Fill/Finish

Find more than just reliable, flexible support along the entire value chain of injectables. Learn how dual-site EU-based operations provide scalable capacity and seamless global supply for your molecules.

OPCU April 2025: Small Molecule

Join Nicholas Duda, Executive Director of Business Development, as he highlights our available capacity across North America, Europe, and Asia, and our unique capabilities.

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.

Connect With Outsourced Pharma: