Analytics & Formulation for biologics
With longstanding experience in biotherapeutics development, the GTP Bioways team provides expert services for the characterisation and formulation of a wide range of biologics.
Learn more about our analytical and formulation services to take the guess work out of your project
Read more about the wide range of analytics we offer.
Host cell protein
Work with the best team to detect process-related contaminants like the well-known and problematic HCP.
Collaborate with us to develop specific ELISA kits.
Benefit from our expertise to develop the most suitable formulation.
Expert services compliant with regulatory requirements
We are very familiar with global cGMP requirements and ICH guidelines and strive to ensure that the data generated through our analytical characterisation and validated release methods conforms to regulatory specifications.
A knowledgeable team dedicated to process-specific HCP ELISA development
GTP Bioways is proud to provide clients with a team of skilled specialists offering the full range of immunoassay development services to address host cell protein and process-related contaminant risk management, from immunoassay development to process-specific HCP ELISA.
We offer a unique and recognised range of services, including research and testing to determine the feasibility of your process, as well as the development and manufacturing of ready-to-use ELISA kits.
GTP Bioways has extensive experience in the successful development of formulations from conventional monoclonal antibodies to complex proteins and other biologics.
Our formulation development team uses their in-depth knowledge of the performance and interactivity of commonly-used buffers and excipients to design a tailored approach for each molecule.
Our formulation service is supported by our state-of-the-art analytical laboratory.
A comprehensive range of analytical services
Our experienced analytical team applies a broad range of methods to support process development and product release. Our laboratory is fitted out with state-of-the-art equipment to enable us to provide advanced characterisation of your product.
The routine activities of our analytical and quality control teams include:
- Method development and validation
- Analytical support for USP and DSP
- DS and DP release for all clinical phases and up to commercialisation
- Stability studies
- Raw material testing and environmental monitoring