PDA Australia Chapter End of Year Dinner

Marc Hogreve has been working for Sartorius since 2006, were he is today Principal Engineer for Integrity Testing. He earned his engineering degree at the “University of Applied Sciences and Arts” in Goettingen. Marc started his career as project leader in the development group for lab equipment for cell culture and microbiology. As of 2011, he has been working as an engineer for integrity testing solutions with a focus on single-use systems for cell culture and fluid management. As a subject matter expert he is working on Sartorius’ global single-use system integrity strategy. He is an active member of task forces in BPSA and PDA and led the creation of three ASTM standards on “Integrity Assurance and Testing of Single-Use Systems”. As a globally known expert, he supports the creation of standards, technical reports and best practices and has also given numerous lectures at conferences on this topic.

Gerry McKiernan heads QA, QC, validation, and Quality consultancy projects for Cell Therapies Pty Ltd and its affiliated units at the Peter MacCallum Cancer Centre. Gerry has 20 years' experience in Quality roles in product development and GMP clinical and commercial manufacturing in Europe, Australia and Asia across biotechnology, pharmaceutical, medical device, and cell and gene therapy industries.

Gerry will talk about GMP challenges for cell and gene therapy products, which are heralding a new era for patient treatment; however these novel products present unique challenges for clinical and commercial manufacturing within established GMP approaches. His presentation shall look at some of these challenges, how these can be overcome and where the industry is heading.

Andrew has a Chemical Engineering degree and 25 years' experience in the design, construction, commissioning, validation and operation of a wide range high tech facilities, including pharmaceutical manufacturing, high containment, industrial cleanroom, hospital pharmacy and specialist research facilities.

As a consultant, Andrew specializes in identifying pathways and solutions to issues of design, compliance, quality and safety. His experience extends to facility layout, design, construction techniques and utility design such as HVAC and purified water, processing and project management – encompassing all aspects of FDA, EU-TGA-PIC/S, local and international standards and general quality practices. Andrew has performed gap analyses on many pharmaceutical manufacturing facilities and sterile/cytotoxic dispensing suites to assess all aspects of compliance. Andrew is a past president of ISPE (Australia) and is an active member of local and international standards committees and independent Chair of ME-060 (Cleanroom Standards) for Standards Australia.