ProteoCell’s in-house Quality team is both experienced and up-to-date with the latest bioprocess industry requirements for biopharmaceutical development and production. Additionally, all of ProteoCell’s work can be tailored to fit smoothly into international Regulatory submissions, using the CTD format, and compatible with both IND and NDA submissions. This is augmented by our Quality team’s commitment to providing both GLP and GMP quality for our clients.
- ProteoCell supports all its bioprocess development and manufacturing operations with a full suite of Regulatory and QA/QC Support services.
- Support on full suite of Regulatory filings, including eCTD filings.
- Guidance and preparation of development, manufacturing process, analytical methods, specifications, procedures, and protocols in support of both non-GMP and GMP Operations.
- Concentration on both Facility/Process and Product.
Whether your bioprocess is still in early developments or your recombinant protein is in advanced clinical stages and you are looking to setup a cGMP or GLP compliant supply chain, ProteoCell’s auditing expertise can help you to ensure that all your third party contractors- from raw materials, equipment suppliers to contract manufacturers and contract laboratories comply with the applicable regulatory requirements. ProteoCell’s auditing expertise can assist you reach this goal; our certified auditors can conduct, report and monitor your supply chain for compliance with Canadian, American and European regulations, ISO 9001:2000 and ICH Guidelines.
ProteoCell also provides a host of bioprocess analytics to complement the development and manufacturing processes. There are standard ICH-driven analytical assays, or custom process assays developed for a certain biomolecule.
- Analytical assay method development, qualification, and validation
- Standard or custom cell-based assays
- In-process analytics development
- Batch release analytics
- ELISA, Western, Electrophoresis
GMP Cell Banking
- Cell banks can be grown and expanded under the standard industry-grade GMP cell-banking protocols, or under exact client-supplied custom protocols.
- Only one cell bank is produced in a cell banking suite at any one time.
- Strict protocols are adhered to minimize possibility of contamination or any other project-related failure.