Essential Laboratory Skills: Aseptic Techniques

This two-day training course is delivered by the Cell and Gene Therapy Catapult Skills and Training Laboratories in-house trainers. Our course is aimed at employees new to biotherapeutics and advanced therapies, or those currently working within these sectors, wishing to learn about and develop the basic aseptic production skills as required to work within production and research facilities supporting the manufacture of biotherapeutics and advanced therapies.

Learning objectives:​

• Understand the need for stringent aseptic GMP standards in the manufacture of different cell and gene therapies​
• Define the responsibilities of all stakeholders, including compliance and process design specialists in bio-production processes – does “aseptic” mean “sterile”?​
• Describe the GxP / cGMP considerations and expectations throughout the bioprocessed product lifecycle​
• Identify potential “risk areas” in a product’s lifecycle​
• Review the compliance of key clean room operational procedures (workflow, gowning, cleaning, environmental monitoring etc)​
• Interpret aseptic protocols, for example media fill or tube welding operations​
• Explain the regulatory requirements for documentation processes​
• Master aseptic behaviours including MSC cabinet etiquette, consumables handling, equipment flow, environmental monitoring and the use of PPE​
• Develop cell culture skills including media preparation, cell counting (manual and automatic), sub-culturing, cold chain operations, use of water or waterless baths and incubators

Who should attend:​​

Training in basic aseptic work is essential for anyone involved in biopharmaceutical manufacturing or working in environments where maintaining sterility is critical. This course is suitable for anyone involved in bioprocessing operations – upstream and downstream manufacturing operators, support and maintenance technicians, process engineers, research and development personnel as well as quality control, environmental monitoring and microbiology staff.