Newsletter | July 30, 2025

07.30.25 -- The Biggest Problem At CDMOs Today

SPONSOR

From solubility challenges to modified release and pediatric dosage forms, we help sponsors overcome development roadblocks with tailored, scalable solutions. We combine formulation and manufacturing expertise with a sponsor-informed mindset that keeps clinical, regulatory, and commercial goals in focus. At AustinPx, we don’t rely on generic approaches. We collaborate across disciplines to build scientifically sound, strategically aligned formulations. This is where complex challenges meet tailored solutions and where your molecule finds a path that delivers.

INDUSTRY INSIGHTS

Diverse Mentorship Models Create Multiple Paths To Employee Success

Since life science professionals hail from diverse backgrounds, educations, and work experiences, different mentorship models serve their varied development needs and learning styles.

Benefits Of Liquid-Filled Capsules In Pharmaceutical Development

Often selected for drugs with poor solubility/bioavailability, these hard-shell capsules serve as a versatile solution and have applications in a number of other situations.

Transitioning Your Product In Clinical Studies

Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.

FEATURED EDITORIAL

The Biggest Problem At CDMOs Today

A perennial outsourcing problem has resurfaced, according to industry sources. It is the misalignment at CDMOs between their business development and tech ops or other project-evaluation teams. Sponsors are again encountering situations where CDMO sales/BD show enthusiasm, but later hear the project has been declined. 

Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs

The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

INDUSTRY INSIGHTS CONTINUED

Removing The Headache

Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.

Formulation Development 101: What Is It And Why Does It Matter?

Discover why formulation development is a critical, high-stakes process that transforms scientific innovation into safe, effective therapies for patients.

SOLUTIONS

Pull Your Fill/Finish Line Closer

Learn how partnering with us gives you access to our unique, interconnected network, purpose-built to overcome the breakpoints common in traditional manufacturing models.

AI-Enabled Route Scouting Service

Observe how we are empowering biotech partners to overcome the complexities of API development and bring life-changing medicines to market faster.

Capacity Update October 2024: Fill/Finish

Jeff Clement, Executive Director of Technical Sales Drug Product Development and Manufacturing, outlines our global sterile fill-finish and lyophilization capabilities, investments, and expansions.

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.

Connect With Outsourced Pharma: