Speed, Quality & Cost – Why You Should be Conducting Your Clinical Trials in Australia

Sterile filtration has been a cornerstone of bioprocessing for over 60 years and as the industry continues its change from stainless steel to single-use, filtration has also evolved, moving from cartridge to capsule format with several membrane types to choose from. This webinar aims to provide an overview of filtration in bioprocessing addressing key considerations when developing a biopharmaceutical manufacturing process.

There are approximately 7,000 distinct rare diseases affecting 350 million people worldwide, approximately 80 percent of which are caused by faulty genes. Scientific advances such as the CRISPR/Cas9 genome-engineering system have simplified the pharmaceutical and biotech industry’s ability to develop gene therapies, especially for single gene mutation disorders. The US Food and Drug Administration (FDA) has more than 700 active Investigational New Drug Applications (INDs) for gene and cell therapies and in 2017, the FDA approved two cell-based gene therapies and it is anticipated that gene therapy will become a mainstay treatment for many rare diseases.

Single-use technology has established itself as an integral part of the biomanufacturing process helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single use systems, and advances in equipment such as sterile connectors have facilitated many of these operations. Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in the final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.

During direct compression tablets are manufactured without pre-granulation. Excipients therefore need to be highly effective, controllable and free-flowing.