GLP-Compliant Bioprocess Services

Compliance to Good Laboratory Practice (GLP) is of fundamental importance and necessity in the investigations of the safety and efficacy of drug candidates. Therefore, GLP is widely used in the non-clinical research phase as a quality control system, to ensure the consistency, reliability, reproducibility, quality, and integrity of safety and efficacy tests. Creative BioMart provides GLP-Compliant bioprocess services to produce recombinant proteins and therapeutic antibodies that supply your in vivo studies, helping you smoothly integrate your results for manufacturing and regulatory application.

Our dedicated efforts include:

• GLP-compliant procedures and well-defined deliverables
• Dedicated project team: GLP-knowledgeable and experienced
• Continuous evaluation and improvement
• Maintenance control: Facility and equipments are properly installed, maintained and operated
• Material control: Receiving and handling of raw materials; releasing, labeling, packaging and shipping of deliverables
• Production and process control

Service Items:

• GLP-Compliant Transient Protein Expression Service
• GLP-Compliant Research Cell Line-Standard Package
• GLP-Compliant Stable Cell Line-Production Level
• GLP-Compliant Process Development

GLP embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Our dedicated efforts include:

• GLP-compliant procedures and well-defined deliverables;
• Dedicated project team: GLP-knowledgeable and experienced;
• Continuous evaluation and improvement;
• Maintenance control: Facility and equipment are properly installed, maintained and operated;
• Material control: Receiving and handling of raw materials; releasing, labeling, packaging and shipping of deliverables;
• Production and process control.

If you have any question regarding GLP compliance, which is not answered by the information on our web pages, you may contact us.