Vaxxas is a Brisbane based Medical Device Company pioneering a next-generation vaccine delivery platform that enables robust immune system activation by targeting vaccine components to the abundant immunological cells immediately below the surface of the skin.
Vaxxas’ proprietary Nanopatch™ technology aims to provide an optimized, differentiated needle-free vaccine delivery solution that safely and cost effectively amplifies vaccine efficacy. The Nanopatch™ approach consists of an array of thousands of vaccine coated microprojections that perforate into the outer layers of the skin when applied with an applicator device. The tips of Nanopatch’s microprojections are coated with a vaccine material and release this material directly to the large numbers of key immune cells immediately below the skin surface.
Application of the Nanopatch™ to the skin is a pain-free method of vaccine delivery and has been shown in preclinical studies to result in a protective immunogenic response, using as little as one hundredth of the dose required by conventional needle and syringe. The robust immune response inherent to Nanopatch-delivered vaccines can also enable reduction or elimination of additives such as adjuvants and proprietary dry-coating of vaccine to the Nanopatch™ can eliminate the need for refrigeration during storage and transportation.
Vaxxas were interested in manufacturing investigational material for early stage clinical trials of their Nanopatch technology. As part of this process the company wanted to ensure that their operators would be comfortable and certified in handling product within a clean room environment. SeerPharma was approached to customise and deliver a Good Aseptic Practices training program with a view of combining theory with some practical components in house.
SeerPharma constructed a training course addressing these needs and delivered material on:
- Introduction to Good Aseptic Practices and Sterility Assurance
- Microbiological Aspects of Sterile Manufacture
- Cleanroom Layout and Air Flows
- Aseptic Gowning Techniques
- Operating in a Cleanroom
- Validation of Aseptic Processing
- Cleaning and Sanitation
Along with providing practical GAP training on:
- Gowning and Entry to a Cleanroom
- Working in a Clean Zone
“Vaxxas has initiated a clinical program to take its novel, vaccine coated Nanopatch into a first time in human clinical study. Seer Pharma has assisted the Vaxxas project with advice on quality requirements and provided GMP training to 25 members of the Vaxxas team. The training was up to date, effectively delivered and included the necessary theoretical and practical work sessions to prepare the Vaxxas team for the upcoming clinical manufacture.”
- Charles Ross, Head of Clinical Operations & Supply, Vaxxas
Contact us to see how we can help your organisation with training or consulting in Good Manufacturing Practices (GMP) or specific GMP areas such as Good Aseptic Practices.
This post comes from our October 2015 Journal. You may also be interested in these posts:
