Manufacture at BTG

BTG operates in a state-of-the-art 10,000 square meters cGMP (current Good Manufacturing Practice) facility

The site is approved by regulatory authorities worldwide, with expertise in:

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

Manufacturing lines are located in a state-of-the-art clean rooms.

The facility undergoes successful GMP inspections and is approved by regulatory authorities worldwide: US FDA, Israeli Ministry of Health, European Authorities, Health Canada, TGA (Australia), ANVISA (Brazil), COFEPRIS (Mexico) MFDS (South Korea), and others.

The company is certified by the Standards Institution of Israel (SII) for the following standards:

• ISO 9001 (Quality Management System)
• ISO 13485 (Medical Devices Quality Management System)
• ISO 14001 (Environmental Management System)
• ISO 45001 (Occupational Health & Safety Management System)
• ISO 50001 (Energy Management System)
• Platinum Certification for being certified on 5 ISO standards

In addition, the company’s NaHA-based medical devices are certified by mdc, the European Notified Body, for the following standards:

• EN ISO 13485 (Medical Devices Quality Management System)
• Medical Device Regulations

The teams at BTG are working together to meet and exceed industry standards required to deliver the highest quality pharmaceuticals. to meet our patient’s expectations and healthcare regulatory authorities requirements.