NBI receives EMA GMP Certificate for Commercial Batches.
NBI receives EMA GMP Certificate for PV Batches.
New Beta Innovation Canada Ltd.’s Facilities Compliant under Health Canada Drug Establishment Regulations
In February of this year, Health Canada auditors completed a rigorous 5-day on-site inspection of New Beta Innovation Canada Limited’s (NBI-CA) facility located in Burnaby, British Columbia. The results were positive with regulators giving NBI-CA a compliant rating. NBI-CA was also granted an initial Drug Establishment License (DEL) for the manufacture, packaging, testing, distribution and wholesale of veterinary pharmaceuticals. This license, valid from June 17, 2019 is a major milestone for NBI-CA towards building the capacity to bring its hemoglobin derived products to market.
NBI-CA is currently one of the only facilities of this size and capacity in Western Canada with the capability to make sterile liquid products as regulated by Good Manufacturing Practices (GMP). NBI-CA’s team has been working towards GMP compliance and becoming a fully operational commercial manufacturing facility since it obtained occupancy of the Burnaby facility in March 2017.
Health Canada conducts drug establishment inspections to ensure that products sold to Canadians meet strict guidelines for quality and safety, with the ultimate goal of preventing harm to the end-user. Some of the things that auditors look for include: sanitation, training, records, written procedures, storage, temperature control, ventilation and product testing to name a few. Auditors made several observations during the inspection that NBI-CA is currently addressing. A follow-up inspection is pending in 2020 to evaluate NBI-CA’s progress and corrective actions.
The upcoming plans of NBI-CA within North America include exploring an option to create a secondary upstream manufacturing facility in addition to our New Zealand Operations as well as filing a new animal drug application with the US FDA. NBI-CA is also in the process of developing its human drug, and has completed the first phase of a Healthy Volunteer Study to Evaluate Safety on the Use of YQ23 in the UK. A Health Canada compliant rating is essential as NBI-CA continues to make strides towards developing these novel treatments for disease.
NBI-CA has a highly qualified team who work collaboratively to achieve quality and regulatory compliance. With a relatively small workforce NBI-CA has achieved a lot, as noted by Health Canada auditors. The team is prepared and ready to meet several other milestones to achieve full GMP readiness according to not only Canadian, but also EU EMA and US FDA regulations.
References:
NBICA Inspection report card summary: https://www.drug-inspections.canada.ca/gmp/fullReportCard-en.html?lang=en&insNumber=71202
About Drug Inspections: https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-products/drug-health-product-inspections/about-drug-inspections.html
Good Manufacturing Practices Inspection Policy: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/inspection-policy-canadian-drug-establishments.html
Good Manufacturing Practices: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices.html
Good manufacturing practices guide for drug products (GUI-0001): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html#a1
NBI receives Health Canada Drug Establishment License (DEL).
Event Sponsor: ICPOEP 2018
sponsors the event of the University of Hong Kong Clinical Trials Centre (HKU-CTC) for the 4th International Conference on Phase 1 and Early Phase Clinical Trials (ICPOEP).
Event Sponsor: ICPOEP 2016
NBI sponsors the event of the University of Hong Kong Clinical Trials Centre (HKU-CTC) for the 3rd International Conference on Phase 1 and Early Phase Clinical Trials (ICPOEP).
NBI receives HK DOH approval to proceed with a Phase 1 Clinical Trial (First in Patient) of YQ23 in patients with advanced tumors.
YQ23 has been granted the Orphan Medicinal Product Designation by the EMA for the treatment of oesophageal cancer.
NBI receives UK MHRA approval to proceed with a Phase 1 Clinical Trial (First in human) of YQ23 in healthy volunteers.
YQ23 has been granted the Orphan Medicinal Product Designation by the EMA for the treatment of hepatocellular carcinoma.