Newsletter | April 4, 2025

04.04.25 -- The Importance Of Primary And Secondary Drying In Lyophilization

FEATURED EDITORIAL

The Importance Of Primary And Secondary Drying In Lyophilization

For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

The BIOSECURE Act Will Be Back… With A Dose Of Tariffs!

Biopharma executives Robert Discordia, CEO, Equulus Therapeutics, and Reza Oliyai, CEO, Oliyai Consulting, agree we may not have seen the last of the Act… or tariffs to compound industry challenges.

Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

Regulatory-CMC defines Sai Prathyusha Bhamidipati’s career at Moderna. Focused on compliance in pharmaceutical production and QC, she highlights its crucial role when working with CDMOs.

INDUSTRY INSIGHTS

The Rise Of Complex OSD Generics: Understanding Development Challenges

Understanding the potential pitfalls and partnering with the right experts can make all the difference in overcoming the complexities of complex generic OSD development.

Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer

The development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

The Rapidly Evolving Oral Solid Dosage (OSD) Landscape

Drug developers and manufacturers must address several key challenges, including formulation complexity, improving the bioavailability of poorly soluble compounds, and optimizing drug release profiles.

Optimized Stability Storage

A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.

A Solvent-Free, Fusion-Based ASD Manufacturing Process

Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

SOLUTIONS

A Modern Pharma MES Solution Offers The Best Of Old And New

Without clear visibility into your operations, you risk creating blind spots that could extend lead times, causing unnecessary waste and quality issues. Consider the advantages of a modern MES.

Bringing Commercial Success To Our Partners Through Our Broad OSD Expertise

By combining deep scientific expertise with cutting-edge technology, we ensure the safety and effectiveness of each formulation through precise control of API release.

Navigate Development Challenges With Our Core Services

Our team of 1,000+ employees operates across two continents, seamlessly integrating drug product development, manufacturing, and clinical pharmacology expertise.

Global Advantage With Free Trade Zones In China

Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.

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.

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