MPTxpress uses a solid media platform to produce high yields, overnight.

No comparable process has been published or patented.

MPT Biotech
 
Frost & Sullivan 2012 Best Practices Award
MicroProtein Technologies Inc (MPT) Delivers Quality and Compliance for cGMP

ISO 9001:2015 Certification Received in June 2018  

  MicroProtein Technologies utilizes our innovative MPTxpress platform to produce recombinant proteins, enzymes, and plasmid DNA in accordance with current Good Manufacturing Practices (cGMP) to ensure that all products are manufactured in compliance with 21 CFR Parts 210 and 211. 

We are committed to delivering beyond our client's expectations and providing them with products which meet their business needs and withstand regulatory scrutiny. MicroProtein's bioprocessing, facility, and equipment conform to the expectations that our clients require for FDA and worldwide regulatory compliance.  Our quality assurance and management systems drive our approach to manufacturing that is specified in our detailed Standard Operating Procedures (SOPs) and managed by our Quality Assurance Team.  Our SOPs detail our measures to comply with 21 CFR Parts 210 and 211, and cover training, documentation, deviations, corrective and preventive actions, quality control testing, equipment maintenance and calibration, environmental monitoring, materials management, product labeling and distribution, batch record management, and aseptic processing.

Quality begins with our staff of experts in MPTxpress technology, other bioprocessing innovations, quality control, and up- and downstream manufacturing.  We are committed to inducting our employees into a company culture of continuous learning and training, developing their knowledge base, and ensuring that they are trained in the latest requirements for compliance with cGMP regulations.  Staff members receive training on regulatory issues and requirements, as well as procedures pertaining to their job functions.  Training records maintained by our Quality Assurance Department document staff proficiency . 

Microprotein's new facilities are carefully designed and maintained to prevent process contamination and adhere to strict requirements for purity and potency.  The facility is zoned into controlled and non-controlled areas to segregate work activities.  Security measures are in place to prevent unauthorized access and all visitors are properly monitored at all times.  Our facilities are adequately sized and designed to handle optimal workflows and equipped with controls to mitigate contamination, cross contamination, and segregation of materials and products.  Environmental monitoring is robust to track conditions and trends that may potentially impact product quality. 

Our Validation Master Plan details our approach to maintaining our equipment in accordance with cGMP requirements.  Equipment is classified, validated, calibrated, and maintained in accordance with its intended use and impact on manufacturing.  The Quality Assurance department maintains a list of all relevant equipment along tracking with frequency of services and due dates.

MicroProtein welcomes further explaining its QC/QA operations, sharing related documentation, and assisting prospective clients in performing related audits and evaluations.

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