Nexxus Scotland

Leigh Rodgers, GMP Supervisor of Cell Culture, Angel Biotechnology

Q : For those of us who don't know - what does the GMP Supervisor of Cell Culture do?

To set my job into context, Angel Biotechnology is a contract biomanufacturing company offering process development services and pre-GMP and cGMP manufacturing to support biotechnology and pharmaceutical companies worldwide.  Within Angel, my functions are to manage the delivery of a variety of cell culture and viral GMP production projects essentially to three main criteria; appropriate quality, time and cost standards.  This requires diverse activities ranging from supporting the scientific team in technical transfer and execution of projects to liaising with the sales team in the development of new project definitions and contracts. 

I have an active role throughout the projects, providing technical expertise within the team and representing Angel during regular discussions with the client to ensure projects are delivered to tight timelines and are GMP compliant. 

It's essential in a service industry for both the smooth running and successful delivery of the projects that a positive relationship is established with the client and we find that regular communication is an important part of that.  I play a large part in that process and this gives me an opportunity to be client facing.  

Angel's principal activity is the manufacture and supply of materials for use in early stage drug development and pre-clinical studies, along with drug product and CMC documentation for Phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines.  With my experience in cell culture, my role presents me opportunities to work with different and innovative cell therapy projects which are an exciting new area for drug therapeutics.   I assist with all stages of cell therapy production, providing bespoke process solutions to include identification of source material, isolation and derivation, ex vivo stem cell expansion, cGMP manufacture and cell banking.

Q : Tell us about a typical day (or is there no such thing?).

No two days are the same, but I can be involved in teleconference with existing and potential new clients, preparing protocols and reports, reviewing GMP compliant documentation, cleandown of the cleanroom areas, environmental/personnel monitoring, development and GMP processes, training operators, internal audits and general maintenance of the GMP facility.  

Being part of a small team you are exposed to all aspects of the client process and are involved from an early stage within technical transfer and development through to delivery of product on client projects.

Q : What's taken up most of your time recently?

We are about to start a phase I clinical trial for one of our long standing clients so recently we have been involved in preparing documentation, liaising with the client and their CRO to finalise arrangements for shipment and manufacture of their phase I clinical material.  This includes performing work to make sure the process is sufficiently robust to manufacture the cell therapy product to GMP.

Q : What's on the cards for the next few months?

In the next few months we are due to start a Phase I clinical stem cell trial for the treatment of stroke.  We are also in discussion with several cell therapy companies to with a view to accommodating their processes from development into GMP manufacture.

Q : What would you want to do if you weren't doing this job?

If money was no object?  Probably be sitting at the ballpark in New York watching a game.  Seriously if I was not working at Angel I would probably still be the cell therapy and stem cell field in research or small Pharma.

I have worked from research-scale stem cell growth and differentiation with a previous company through development and GMP production of stem cells and autologous cell therapies at Angel.  Previous to this, I worked in large Pharma supervising the preparation of both mammalian and class II/III viral banking to GLP and in a smaller pharma company working with mammalian cell culture processes through development to GMP manufacture.   So in my 11 years in cell culture I have gained experience in cell culture processes from research level through development and GLP to full scale GMP Manufacture.

For further information, contact Leigh:
T: 0131 445 6044
E: leigh.rodgers@angelbio.com

For general information on Angel Biotechnology:

E: bus.dev@angelbio.com
W: www.angelbio.com