Quality Assurance & Regulatory Support
BioCina is committed to excellence in Quality. Our commitment and phase appropriate approach to Quality supports our clients through the development lifecycle of their clinical programs as well as the manufacture of commercial products to a standard that ensures the wellbeing and safety of end users, the patients.
Our Quality systems and culture is driven by risk-based scientific thinking and decision making which ensures the manufacture of high-quality biologic bulk drug substance. Our operations are carried out to the highest cGMP standards to ensure we meet the requirements of the most highly regulated markets globally.
Our Quality team consists of experienced and cross-trained specialists in: Quality Systems, Manufacturing Quality, Chemical Quality (CQ), Biological Quality (BQ) and Validation. This end-to-end capability ensures our team is skilled and focused on meeting our clients’ needs
The BioCina facility boasts successful inspections from Australia’s Therapeutic Goods Administration (TGA) and the U.S. Food and Drug Administration (US-FDA) and our team has also supported successful product approvals from the EMA and Health Canada. Since the facility’s original licensing by the TGA in 2004, we have consistently satisfied all compliance and regulatory standards for GMP certification.
In 2020 our facility, in support of a BLA product approval, was approved by the US-FDA to manufacture product for commercial supply in the US market. The facility is currently the only microbial drug substance facility of its kind in Australia to be US-FDA approved.
At BioCina, it is our goal to ensure that product quality remains uncompromised along the entirety of the manufacturing timeline. Our quality control team rigorously monitors and tests samples throughout the manufacturing process, ensuring the standard of excellence required for cGMP clinical and commercial manufacture.