The IVB testing includes mouse, rat and hamster antibody production; inapparent virus assay; tumorigenicity and a range of general safety tests according to Good Laboratory Practice (GLP) and GMP guidelines. CRL offers extensive experience in the area of in vivo immunogenicity and biological potency assay development; validation; and implementation including neurotoxins, hormones, anti-venoms, vaccines, and allergenic products.

Detection and quantification of DNA in a biopharmaceutical product is very important in its safety evaluation. We offer highly sensitive, robust and validated methods for quantification of residual DNA, PCR development, copy number and DNA sequencing. Molecular biological aspects of an expression construct are compared at various time points to demonstrate their genetic identity, integrity and stability.

Methods such as HPLC and Electrophoresis are often used for product characterization. A variety of analytical methods such as protein glycosylation studies, protein purity and identity, generic and Host Cell Protein assays, assays for contaminants like BSA, Protein A and stability testing. Product characterization, in vitro potency assays and determination of residual host cell proteins are important regulatory requirements and these services are also offered by us.

From mammalian cell banking to clinical-scale vaccine manufacturing, Charles River’s GMP-compliant manufacturing capabilities complements its testing services to offer a comprehensive list of services for your biopharmaceutical product all from one convenient and reliable source. CRL manufactures cell banks for mammalian, microbial, insect, yeast and stem cells and provides the appropriate cell storage services under GMP guidelines.

Characterisation services include testing of purity, sterility, identity and genetic stability along with pre bank characterization and an array of other characterization assays. Creation of Master cell banks (MCB), Working cell banks (WCB), research cell banks (RCB), end-of-production cell banks (EOP) cells and cells at the limit of in vitro cell age can be prepared as per client specifications and stored for client desired duration of storage in vapour phase liquid nitrogen. The material is well segregated to minimize cross contamination in dedicated dewars for mammalian, microbial, and insect cell banks.

CRL has proven expertise in working with various cell substrates and viruses and preparation of vaccines for clinical trials utilising egg and cell based production methods. In vivo biosafety and toxicology testing for vaccines is also offered. Charles River Laboratories work closely with each client to provide vaccine companies with considerable flexibility and convenience in the development of their vaccines.

All manufacturers of biologics are required to assess the ability of the manufacturing process to generate a product safe for human use; therefore, a viral clearance study is performed to evaluate each step of the manufacturing process and to ensure that it is effective at removing or inactivating viruses. A customised approach that includes advice and regulatory support in the selection of process steps and model viruses, scaling down of purification processes, and subsequent design of the study protocols to suit your requirements and deadlines.

Release testing packages are composed of a range of studies previously validated to demonstrate compliance of the product. CRL provides product release for the European Union, US, and other distinct regulatory markets. All products entering the domestic or global pharmaceutical markets require GMP testing to ensure that they are released in accordance with approved specifications.

Charles River Laboratories provides drug substance, in vivo stability and final product stability testing, and storage services in compliance with current International Conference on Harmonisation (ICH) guidelines to support clinical studies, licence applications, and post-marketing commitments.