Specialized FMT Manufacturing
We understand the importance of manufacturing under stringent standards to create consistent, safe and scalable high-quality FMT products. We prioritize quality and safety in every aspect of our operations, and our commitment to producing high-quality FMT products is reflected in our use of Good Laboratory Practices (GLP) and our current goal of obtaining our Health Canada Drug Establishment Licence (DEL) and GMP certification.
GMP is a set of guidelines established by regulatory agencies that ensure the quality, safety and efficacy of pharmaceutical and medical products, such as FMT. These guidelines cover all aspects of the manufacturing process, from raw materials screening, standard operating procedures (SOPs) and quality assurance processes to packaging and labelling of finished products. At Novel Biome, we are currently in the process of obtaining our GMP certification.
About Our Manufacturing
At Novel Biome, we adhere to GLP standards to ensure our FMT product's quality, safety and consistency. GLP stresses the importance of having highly trained personnel, quality facility and lab equipment, optimization of test systems and processes, and adverse event reporting.
To ensure the Quality, Safety and Consistency of our FMT products we place the highest stands on:
- Hiring the Very Best Lab Personnel
- Purchasing the Best Facility and Laboratory Equipment
- Ensuring our Test Systems and Processes are Optimal
- Exceptional Manufacturing Processes, Quality Assurance and Standard Operating Procedures
- Stringent Donor Screening, Blood, and Stool Testing
- Adverse Event Reporting