In August 2020 MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage gene therapy company, announced a multi-million euro expansion at its facility at Shannon, Co. Clare, Ireland.
The site at Shannon is a cGMP viral vector manufacturing facility and a cGMP plasmid production facility. These facilities are designed for the manufacture of commercial-grade gene therapies in a fully integrated manner supported by MeiraGTx’s global quality assurance organisation.
The MeiraGTx Irish based facilities, provide additional flexibility as well as further large-scale capacity for clinical and commercial supply of its gene therapy product candidates from pre-clinical stages through clinical trials and potential commercialisation.
Working closely with the MeiraGTx team, NIBRT designed and developed customised training programs focused on Meira GTx’s manufacturing process.
The MeiraGTx team learnt the underlying theory behind the complete set of unit operations involved in their process and how those steps integrate to generate a product. In addition, they studied how to conduct the various steps using equipment that is representative of what they have on their own site.
This course gave MeiraGTx the opportunity to become familiar with and practice on pieces of equipment away from the constraints that are found in a manufacturing facility. The training with NIBRT enabled MeiraGTx to accelerate the start-up of their manufacturing operations.
Meira GTx - Senior Bioprocessing Scientist
We asked Ellen Duggan, Senior Bioprocessing Scientist at Meira GTx, to reflect on her experience with NIBRT training and ways of working.
How did you find out about the Training?
I found out about NIBRT because I was here previously with a company before MeiraGTx and I found the training insightful and beneficial, it’s very tailored towards our process, there is very small classroom sizes, there is a mix between online lectures and the practical training in the lab.
How will the training benefit your current role?
This training will really benefit me in my current role because I came from a stem cell therapy background and now coming into the gene therapy area I wouldn’t not be familiar with a lot of the equipment that is used, especially the downstream processing. So it was really good for me to come to NIBRT to learn all about the different types of equipment that we are using in our process, this will really help me when I go back to Meira to do our plasma and viral vectors manufacturing.
How did you find the training in NIBRT?
I found the NIBRT trainers were brilliant, they are helpful and friendly they are very insightful with a lot of knowledge, some of them have come from industry backgrounds and others from PhD and research backgrounds, it’s a good mix of trainers. We got a huge amount from the training in NIBRT and there was no question that we asked that wasn’t answered by the trainers, so it was extremely beneficial for us.