The Process Development Blog

Avoid FDA Complete Response Letters (CRLs) by focusing on a strong CMC strategy, deep process understanding, and scientific excellence to ensure smoother drug approvals.

The Medicine Accelerator proudly announces its triple win at the 2024 Pharma Industry Awards, securing Biotech Company of the Year, Pharma Company of the Year - SME, and Pharma Industry Company of the Year. Shortlisted in eight categories, APC and VLE stood out for their excellence in scientific innovation, operational performance, sustainability, and talent development.

Decoupling process development from manufacturing enhances control, flexibility and innovation - accelerating time to market and reducing risks in pharmaceutical development.

We’ve curated a list of key crystallization publications from the past 25 years, showcasing the research and breakthroughs that have defined our approach and expertise. These publications represent the culmination of decades of innovative work by APC’s crystallization experts, illustrating our ongoing impact in this field.

This study introduces a hybrid method combining the COSMO-RS model with machine learning to predict aqueous solubility at room temperature.

Explore these innovative approaches undertaken by APC in addressing the challenges of peptide crystallization .

Biostór and VLE Therapeutics have established a strategic alliance to deliver an end-to-end (E2E) cell banking solutions. This post outlines the detailed process of our collaboration, from initial consultation to final delivery, emphasizing the integration of our services.

Decentralized manufacturing in pharma, driven by ATMPs, is now extending to traditional large & small molecule medicines, transforming development & production.

Michael Jordan is widely regarded as the greatest basketball player of all time. But beyond his athletic prowess, his philosophy offers invaluable lessons for CMC professionals. Discover how the principles that guided MJ’s legendary career can be applied in pharmaceutical manufacturing.

Process portability is a concept pioneered by APC which encompasses the capability to seamlessly transfer robust manufacturing processes across different facilities or locations without compromising product quality or efficiency