Manufacture at BTG

BTG operates a state-of-the-art 10,000 square meter cGMP multi products manufacturing facility

Approved by regulatory bodies worldwide, with expertise in:

• Large-scale bacterial fermentation
• Mammalian cell culture
• Macromolecular separation and purification
• Aseptic filling of highly viscous liquids in prefilled syringes
• Automated packaging
• Chemical, microbiological, immunological & instrumental analyses
• Biopharmaceutical compliance

Manufacturing lines are located within individual suites and rooms

Each with their own clean air and water supply to minimize potential for cross contamination. The facility undergoes routine GMP inspections by regulatory bodies worldwide.

The manufacturing facility has been approved by regulatory bodies worldwide, including the U.S. FDA, European Regulatory Authorities, the Israel Ministry of Health, Health Canada, the Australian TGA, KFDA (South Korea), ANVISA (Brazil), South African MOH and others.

The facility has also been approved by the Israel Standards Institute (SII) and German MDC notified body, and obtained:

• ISO 9001 (Certified Quality Management System)
• ISO 13485 & EN ISO  13485 (Certified medical devices Quality Management System)
• ISO 14001 (Certified Environmental Management System)
• OHSAS 18001 (Certified Occupational Health & Safety System)
• ISO 50001 (Certified Energy Management System)

Together the teams at BTG are dedicated to meeting and exceeding industry standards required to deliver the highest quality pharmaceuticals to meet our patient’s expectations and healthcare needs. All our supply chain departments work together in a seamless interface from manufacture,  quality (QA+QC), along with, product and technology support, project and operational management, to maintenance and engineering to ensure that only the highest quality products leave the facility.