Catalent has the broadest drug development toolkit, offering clients multiple technologies to enhance the bioavailability and solubility of drugs during formulation.
Micronisation is a proven, dependable and versatile method to achieve high quality particle size reduction to assist in API and formulation optimisation. Catalent Micron Technologies is a global leader in particle size reduction services, delivering high quality micronisation, milling, and analytical services. Its full range of capabilities includes:
• Development through to commercial scale
• Micronisation (jet mill)
• Mechanical milling (hammer mill, pin mill)
• Cryogenic milling
• Controlled handling of potent and cytotoxic compounds
• Comprehensive supporting analytical services
Spray drying can also assist in overcoming formulation and development challenges, and from its facility in San Diego, Catalent offers this service from early phase development through to clinical manufacturing scale. With over 75 years’ experience in spray drying and amorphous dispersion technology, the Pharmatek SD spray drying team can fully characterise an API and associated formulations throughout feasibility, development, and commercialisation, to provide a robust data package in support of regulatory filings.
The Pharmatek SD spray drying technology offered by Catalent is integrated into its extended OptiForm Solution Suite platform, which allows drug developers to gain an insight into accelerating programmes from late-stage discovery to phase I trials.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Your Ultimate Guide for CMC Testing Support for Gene and Cell Therapy
November 21st 2024Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.