- Cytovance Biologics has expanded its analytical services portfolio to offer standalone analytical support without requiring clients to engage the company for manufacturing services.
- The expanded offering includes method development, transfer, qualification, validation, characterization, release testing, stability studies and storage under GMP and non-GMP environments.
Cytovance Biologics has expanded its analytical services portfolio to provide standalone analytical capabilities to biotechnology and pharmaceutical companies. The U.S.-based CDMO said clients can access its analytical team and regulatory-ready solutions without entering into a manufacturing engagement.
The expanded services cover analytical method development, transfer, qualification, validation, product characterization, release testing, stability studies and storage. Cytovance said the services are available for programs ranging from early-stage development through commercialization and can be delivered under both GMP and non-GMP environments.
The offering is intended to support companies with limited internal laboratory resources and growing analytical requirements. As programs progress, clients can use GMP-compliant testing and stability services to support regulatory submissions, process validation and commercial readiness.
Cytovance said the standalone model allows sponsors to use its analytical capabilities at different stages of development, including for individual analytical studies, ongoing stability programs and routine GMP testing. The company said the expansion builds on more than 20 years of experience supporting biologics development and manufacturing programs.
The company expects demand for U.S.-based analytical services to grow alongside expanding biologics pipelines. Cytovance said the expanded offering is intended to provide flexible analytical support for biologics developers while allowing sponsors to maintain flexibility in their broader development and manufacturing strategies.
