Profacgen is capable of providing professional GLP Compliant Protein Production service to accelerate our customer’s preclinical drug development process.
GLP (Good Laboratory Practice) refers to a set of principles that provides a framework for studies that are planned, performed, recorded, reported, archived and monitored. GLP-validated assays and manufacturing services under GLP guidelines help assure regulatory authorities that the data submitted are a true reflection of the results obtained from preclinical study and therefore can be relied upon when making safety assessments.
GLP quality standards set up a quality system of management controls for research laboratories and organizations to ensure the consistency, reproducibility, quality and reliability of pharmaceutical and non-clinical safety assays. These standards guarantee the investigation of safe and efficient drug candidates to be undertaken in a harmless and effective way. Therefore, they are widely used in the non-clinical research phase as a quality control system.
Specifically, GLP principles cover a wide range of aspects, including organization and personnel responsibilities; quality assurance program; requirements for facilities, equipment, reagents, materials and test systems; standard operating procedures, reporting of results and archival storage of records and reports.
Moreover, scale-up production and purification of recombinant proteins in large quantities can be realized under GLP guidelines. At Profacgen, documentation of all procedures is retained, and the facility is monitored for compliance to ensure the delivery of consistent, reliable and reproducible products and data.
Profacgen provides GLP Compliant Protein Production service to facilitate your preclinical studies, which eventually helps integrate your research results into manufacturing and regulatory applications.
Our GLP-Compliant services include:
|Transient Gene Expression and Protein Production|
|Stable Cell Line Development|
Reliable and Reproducible data
Support reconstruction of studies
Profacgen provides you with an ultimate solution of GLP-compliant protein production service, which also can be tailored according to your specialized requirements.
Please contact us for more details of our preclinical GLP-compliant protein production service. Our experts will provide and help design an optimal solution for your project and trouble-shoot for you throughout the whole process.