Newsletter | September 30, 2026

09.30.26 -- Speeding ATMP Development Without Sacrificing Quality

SPONSOR

 

AAPS PharmSci 360 2026: Formulation Partnerships With Mikart

Mikart brings nearly five decades of CDMO experience to oral solid and nonsterile liquid drug development. From pre-formulation through scale-up and commercialization, its integrated formulation, analytical, and manufacturing teams help address complex challenges while supporting regulatory readiness and manufacturability. With specialized expertise in pediatric and geriatric dosage forms, Mikart develops patient-centric solutions focused on palatability, dosing flexibility, and adherence. Meet Mikart at AAPS PharmSci 360 2026 to discuss advancing your formulation from bench to commercial production.

INDUSTRY INSIGHTS

 

Revolutionizing The Development And Manufacturing Of Peptides

Review the analytical challenges of proteins, peptides, and oligonucleotides — and why every method-development problem is solved by understanding what the customer is trying to achieve.

 

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.

 

Enabled Form Selection For Oral Drug Products

Review the role of solid form screening and PBPK modeling to enable accelerated timelines desirable in early-phase drug development. Explore formulation maps for ASDs and key criteria for salt screening.

FEATURED EDITORIAL

Speeding ATMP Development Without Sacrificing Quality

Innovation requires new thinking and approaches. It also heightens the need for disciplined execution. With ATMP development – as well as with any program – starting out on a path lined with outsourcing principles may prove your greatest competitive advantage. A discussion from Chief Editor Louis Garguilo.

 

Great Science Isn't Enough: Solving The Global Health Drug Development Equation

Designing infectious disease interventions for low- and middle-income countries requires solving for access, affordability, and delivery from day one rather than treating them as downstream afterthoughts. In this inaugural episode of Outsourcing Against the Outbreak, Dr. Krishnan Ramanathan, Interim CEO of the Gates Medical Research Institute (Gates MRI), explores how to navigate the unique economic and operational realities of global health R&D.

INDUSTRY INSIGHTS CONTINUED

 

Accelerating An Innovative High Potency Oncology Therapy To Market

Assimilate how disciplined containment, proactive risk management, and collaboration accelerate oncology programs under tight timelines while protecting quality, safety, and global launch readiness.

 

What Is Hot Melt Extrusion, And How Can It Benefit Your Drug Product?

Poor API solubility delays pipelines. Discover how hot-melt extrusion creates amorphous solid dispersions to break down crystal lattices and boost bioavailability via solvent-free manufacturing.

 

The CDMO Pricing Playbook

Why do two CDMOs with identical direct costs quote prices 2.6x apart? Learn the three-element pricing framework, capacity utilization math, and market-based strategies that explain every RFQ surprise.

SPONSOR

 

 

Join us online for Your CDMO Quality Oversight Is Not Working on October 1, 11 AM ET. Explore how sponsors can improve oversight while maintaining strong CDMO partnerships. Our expert panel will share practical strategies for managing deviations, change controls, investigations, technical risks, and accountability. Discover how collaborative, risk-based oversight can improve process performance, strengthen CMC visibility, and help organizations meet regulatory expectations. Register online today.

SOLUTIONS

API Sterilization

Your Trusted CDMO Partner In Pharmaceutical Development & Manufacturing

Advancing Health Through Decades Of Packaging Innovation

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: