General November 2019
AusBiotech conference highlights in CBE's October Activity report
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October was another productive month at CBE, with ongoing reviews, audits and risk assessments. CBE director Alison Mew attended AusBiotech conference that featured several exciting presentations. Highlights included Elizabeth Finkel’s talk on the enormous potential of new gene therapy technologies. The advances hold the potential to provide simple and cheap alternatives to cure and prevent lifelong treatment regimens. While there are 12 gene therapies currently on the market this is number is expected to rise to 40 in 2020.
There was also a fascinating panel on medicinal cannabis examining how Australia is uniquely positioned to take advantage of the growing global market for the drug. Alison said the conference showcased a wide ecosystem within biotech with tremendous potential for expansion into different markets. “It is not a zero-sum game, we all need to work together to benefit the sector as a whole,” Alison said.
CBE director Andrew Watson was also busy designing modifications to a dog chemotherapy administration suite at a Melbourne vet clinic that includes HVAC modification and addition of a Cytotoxic Drug Safety Cabinet.
Read more about our work below:
- Standard Commitments: Imminent release of the new AS 1807 standard for public comment and the release of ISO 14644 Part 3
- Clean Build Protocols Article: Article about to be released in the Clean Air and Containment Review.
- Board appointment: CBE director Andrew Watson joined the editorial board for IEST.
- Audit support: Supporting a client with an international auditing exercise
- Quality Management System: Designing and developing a Quality Management System (QMS) to US CFR 820 / ISO 13485 to right size for a virtual company
- Risk Assessment: Facilitated a risk assessment for potential contamination control in a multi-purpose clinical trial facility
- New GMP License: Meetings with client and regulators to initiate a GMP licensing audit of a new API facility