Newsletter | August 8, 2025

08.08.25 -- Tech Transfer 2025 – A High-Stakes Game Of Trust

INDUSTRY INSIGHTS

Human Factors Testing: Engaging Users In Med Device Development

Explore the significance of human factors in the development of medical devices by illustrating the importance of incorporating end users in the process.

Phase 1 Clinical Plans: Laying The Groundwork For Success

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations

Examine combination case studies that demonstrate bevacizumab paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

FEATURED EDITORIAL

Tech Transfer 2025 – A High-Stakes Game Of Trust

Trust us. You'll want to read this editorial from Chief Editor Louis Garguilo, who was (gently) reminded he hadn't visited the subject of tech transfer in a while. He answers the questions both sponsors and CDMOs ask to gain the trust to make a tech transfer work for both sides.

Preparing For FDA's Use Of Unannounced Inspections At Manufacturing Facilities

The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

INDUSTRY INSIGHTS CONTINUED

Achieving Desired Particle Size And Yield Through Efficient Micronization

In this webinar, experts examine how the right combination of advanced technology and specialized expertise can leverage micronization to address the challenges often faced by small molecule drugs.

Nose To Brain (N2B) Drug Delivery – Benefits And Challenges

Delve into the growing interest in methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).

SPONSOR

Administering drugs directly to the lungs is becoming more popular, not only for treating common respiratory illnesses like asthma and COPD but also for delivering drugs throughout the body. Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs. Learn more

SOLUTIONS

Comprehensive Batch And Lot Testing Services

Ensure pharmaceutical tablet safety and efficacy through batch testing, including breaking force, friability, disintegration, and dissolution analyses aligned with strict regulatory standards.

Solving Complex Formulation Challenges From Coast To Coast

We provide science-first solutions for challenging molecules, specializing in particle engineering, bioavailability, and GMP manufacturing across Bend, OR; Clearwater, FL; and Gainesville, GA.

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: