Rachel Todd, Regulatory Affairs, United States
Backed by the scientific resources and global manufacturing network of Pfizer, we deliver science at its best and global regulatory support for your biologics development.
We provide access to large molecule biologics experience and compelling science to help partners reach key development milestones with confidence.
With an open and collaborative approach to our partnership with you, we take the time to understand exactly what you need and give you honest advice throughout the development journey.
We’re experts in the production of therapeutic proteins using expression in recombinant organisms including:
We deliver reliable lyophilization as well as comprehensive vial and syringe drug product capabilities.
Time is life and experience is key with gene and cell therapy, so choosing the right biologics CDMO partner is critical.
With a global team of Pfizer gene and cell therapy scientists and manufacturing experts, we have the experience in developing and manufacturing scalable viral vectors across multiple serotypes, in a significant number of GMP batches with proven quality control.
Our extensive network of global regulatory experts, analytical and quality control engineers, means that we can help you overcome bottlenecks and troubleshoot. We are ready to help ensure your innovation reaches your patients fast.
We develop and manufacture your products using Pfizer's Global Quality Systems.
You gain access to comprehensive quality control services compliant with the European (Ph.Eur.), United States (USP) and Japanese (JP) Pharmacopeias and a regulatory team with experience of working collaboratively with authorities across the globe.
We’ve walked in your shoes and understand the challenges you face. We’ll help guide your large molecule biologics from development to commercial-scale manufacture, and our unwavering commitment to your IP confidentiality means the secret to your success is always safe with us.
Our bench and pilot-scale studies can enhance process development, process optimization and tech-transfer capabilities, reducing downstream manufacturing risk and ensuring long-term clinical and commercial supply.
