53Biologics provide the protein analytical services you need at every stage of your journey
Our laboratories are equipped with the most advanced instruments and equipment complying with GMP requirements. We provide method development, qualification, validation and transference according to the analytical method lifecycle for your recombinant protein analysis.
Raw Material Analysis
Ensure the safety and quality of your raw materials through comprehensive analyses specific to your product and your requirements.
Cell Bank Testing
Ensuring the safety, consistency, viability and reliability of cell banks (MCB, WCB, EOPCB) used to produce your biological drug.
In-process Control Analysis
Analytical tests that ensure consistent product quality and faster development enabling us to supply biological products with complete confidence.
Method Development and Validation
Develop and validate reliable analytical methods to ensure the quality and reliability of your cell bank, drug substance or drug product.
Release Testing
A wide range of analytical methods covering active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs) and finished commercial products.
Stability Testing and Storage
Conduct stability studies to assess the long-term behaviour of your drug product under various conditions, including in specific cases accelerated degradation studies.
In order to successfully develop, produce, and market biologics, 53Biologics provides a full range of analytical services. Our cutting-edge labs and highly skilled staff are prepared to support your product from early development through commercial launch since the intricacy of biologic medications necessitates accurate and sophisticated testing. We guarantee the highest levels of quality, safety, and regulatory compliance at every stage of the product lifecycle with our analytical services.
Discover more about 53Biologics CDMO services
We would love to hear from you!
Please note that job applications submitted through this form will not be considered. Use the Careers page.