Newsletter | June 10, 2026

06.10.26 -- A CMC Playbook For Leadership And Hiring

SPONSOR

Tech transfer is inherently risky due to undocumented process nuances and tacit knowledge. To mitigate quality risks and logistical complexity, pharma sponsors should partner with a single-site, U.S.-based CDMO, which improves accountability and preserves critical program insights from early development through commercialization. Click here to learn more.

INDUSTRY INSIGHTS

Sterile Filtration Of Budesonide As A Preferred Sterilization Strategy

White Paper | Curia

Accelerate development of high‑quality inhalation therapies by leveraging sterile‑filtered budesonide to safeguard purity, stability, and patient safety.

Early-Phase Injectable Formulation Development

White Paper | Thermo Fisher Scientific

Discover how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

Accelerating Clinical Development: Modern Tools In Process Chemistry

Webinar | Lonza

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

FEATURED EDITORIAL

A CMC Playbook For Leadership And Hiring

By Louis Garguilo, chief editor, Outsourced Pharma

Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know. That’s a provocation underlying a number of conversations with senior leaders in regulatory CMC, and it feels especially relevant to outsourcing. With the correct attitude and leadership, learning (yes, on the job) may beat credentials for long-term success.

Why FAT Should Confirm Alignment, Not Reveal Its Absence

By Juergen Metzger, Pharma-Technology-Consulting LLC

In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

INDUSTRY INSIGHTS CONTINUED

Process Re-Design For Sustainability In Small Molecule Manufacturing

Webinar | Lonza

Review the optimization of the manufacturing process of a pharmaceutical intermediate, and discover how yield can be improved substantially via suitable reaction engineering.

Fast-Track Innovation, Address CMC Challenges In Expedited Pathways

Webinar | Quotient Sciences

Learn to overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

Multifactorial Disease Models: De-Risking Topical Formulation Development

Article | MedPharm

Traditional drug models fail to predict performance in human skin. Advanced, multifactorial ex vivo disease models directly address inflammation and infection to de-risk formulation development.

AAPS PharmSci 360 2026: Formulation Partnerships

Article | Mikart

A preview of AAPS PharmSci 360 2026 highlighting formulation science, patient‑centric oral dosage forms, and strategies for translating early research into scalable, manufacturable drug products.

SOLUTIONS

Small Molecule Drug Substance Updates

SK pharmteco

Contract Drug Development, Manufacturing, And Analytical Testing

Altasciences

Blister Solutions

Ropack Pharma Solutions

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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