Catalent, Inc services

At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current regulatory environment, and have a history of the development and qualification of analytical methods. We operate with a forward-looking methodology by deploying robust and reproducible analytical methods during preclinical development for a seamless transition into manufacturing. The analytical methods created during preclinical development play a major role in any regulatory filing and can potentially accelerate product and process development. Our team implements robust QC assays to measure the quality and consistency of your ?nal product throughout the process.

Catalent Biologics provides support for in-process testing and formulation development. Testing capabilities provide support in a timely manner to minimize impact to manufacturing processing or development activities: In process quality control checks, Formulation screening, DNA clearance, Process related impurities, e.g. host cell proteins.

At Catalent Biologics, we understand the increasingly complex analytical and regulatory requirements for biologics and other large molecules and also new technologies and techniques that can be employed. We offer one of the broadest ranges of biologics and other large molecule analytical services in the industry, all under full CGMP compliance. Our biologics analytical services can be provided as a standalone service or integrated into development and manufacturing. We provide services for drug substance, drug product, and intermediates, both New Biologic Entities and Biosimilars/Biobetters and can provide support throughout the drug development pipeline, from pre-clinical testing through to post-approval release and stability. Through our experienced scientific team and range of capabilities, our goal is to serve as a strategic partner that can support all our customers’ analytical development and testing needs.

Drug product development can be a daunting and expensive process.  Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing process and validation methods used to evaluate the drug product performance must be accurate and precise.

We can develop methods at any stage of the product development process. With up-to-date knowledge of regulatory requirements and technologies, our scientific staff can provide our clients with well-developed strategies to guide, customize, and execute the method development plan in an efficient manner to meet clients’ requirements and timelines.