Navigating CMC Pitfalls: Avoiding FDA Complete Response Letters (CRL’s)
Avoid FDA Complete Response Letters (CRLs) by focusing on a strong CMC strategy, deep process understanding, and scientific excellence to ensure smoother drug approvals.
Cutting edge process development insights and news from APC.
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.
APC & VLE Therapeutics is looking forward to seeing you at Biotech Outsourcing Strategies on November 26-27th, 2024 in Manchester!
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.
We will be at booth #99 Oct 29-31, 2024 in Barcelona to discuss your vaccine development and manufacturing challenges. Don't miss the technical presentation from our experts.
This study introduces a hybrid method combining the COSMO-RS model with machine learning to predict aqueous solubility at room temperature.
APC & VLE Therapeutics is looking forward to seeing you at BIO-Europe, in Sweden.
Explore these innovative approaches undertaken by APC in addressing the challenges of peptide crystallization .
Join us at Biomanufacturing World Summit, San Diego at booth # 13 to meet one-on-one and discuss your development and manufacturing challenges and our approach to accelerating your medicines through CMC hurdles.