Cytovance Biologics has launched standalone analytical services for biopharmaceutical companies, allowing clients to access analytical testing without also using the company for development or manufacturing.
The new offering includes GMP and non-GMP analytical testing across stages of biologics development. Services include analytical method development, method transfer, qualification, validation, product characterization, release testing, stability testing and storage.
Cytovance said the services are available for both microbial and mammalian biologics programs. The offering is intended to support companies from early-stage development through commercial manufacturing.
The company said clients can engage Cytovance for specific analytical needs, including method development and qualification work, product characterization, clinical material release testing, stability programs and commercial product support.
Cytovance’s analytical services had previously been included within its wider contract development and manufacturing organization offering. The standalone model permits sponsors to use the company’s analytical services independently of its manufacturing capabilities.
John S. Furey, Cytovance’s chief executive officer, said the launch reflects demand for analytical support in biologics development. He said the company’s analytical operations support customer programs at multiple points in the development process.
The standalone analytical offering is available to customers requiring non-GMP support during development as well as GMP testing for clinical and commercial programs. The company said the services may support clients preparing materials for clinical trials, advancing manufacturing processes, conducting stability studies or developing data packages for regulatory filings.
Cytovance said its analytical teams support biologics development through work involving analytical methods, quality testing and characterization. The new model provides access to those capabilities for customers that are not using Cytovance for integrated development or manufacturing programs.