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eXmoor process engineering eXpert Andrew Provan will be in Barcelona next week as the instructor for the ISPE Pharmaceutical Waters training course.

Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW).

This classroom course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

eXmoor is seeking a new Head of Process Development and two experienced Bioprocess Technicians to join its Cell and Gene Therapy process development team. The successful candidates will help to develop manufacturing processes and technologies for clients’ Advanced Therapy Medicinal Products (ATMP). eXmoor’s labs are based in Future Space, one of Bristol’s newest and most exciting tech innovation hubs.

  • The Head of Process Development will enthusiastically lead the growing lab team as they commercialise and improve manufacturing processes and new technology. This respected individual will have a strong technical knowledge of ATMP manufacturing processes, a relevant PhD / MSc, recent hands on experience in the lab and demonstrable team leadership. See Head of Process Development Job Description for more information.
  • The Bioprocess Development Scientist will have a PhD/ MSc in a Biological Sciences, Biochemical Engineering or related degree, a minimum of 2 years process development experience with cell and/or gene therapies and an understanding of the ATMP regulations. See Bioprocess Development Scientist Job Description for more information.
  • The Bioprocess Technicians will have a least 2 years experience in a biochemistry, microbiology, or biotechnology R&D laboratory preferably working with cells and various analytical techniques. See BioProcess Technician Job Description for more information.

Tell us why you would like to be part of our team, attach your cv and send to info@exmoorpharma.com

eXmoor Process Consultant Andrew Provan will be presenting at talk entitled “Next Generation Technologies – Gene Therapy and Viral Vaccines as a UK USP” with Allergan and Cobra Biologics at the Bionow Pharma Manufacturing Conference on Wed 23rd May 2018.

The Bionow Pharma Manufacturing Conference is a one-day conference addressing the needs and requirements of pharma manufacturers who compete on the global stage.

The programme is being developed in conjunction with large pharma Members of Bionow to explore and address routes to efficiency, improved cost of goods, process development and the capabilities needed to exploit next generation technologies.

Through a combination of workshops, lecture and panel sessions, delegates will hear about and be able to contribute to the discussions in the key areas of:

  • Skills & Mindset – how can we do it better with a new approach
  • Next Generation Technologies
  • Steriles Manufacture
  • Innovation in Analytics
  • Regulatory Challenges and Opportunities
  • The Innovation Supply Chain

We have a new member to the Process Development team at our Future Space Bristol labs. Welcome Sally Allison!

eXmoor process consultants helped to organise and accompanied some of our client representatives at the ISPE workshop on VPHP Decontamination & Validation held in February 2018.  https://www.youtube.com/watch?v=NF-yy8c7AG4

The use of Enzymatic Indicators are an exciting development given their potential to accelerate vapourised hydrogen peroxide (VPHP) gas cycle development (GCD) studies, qualification and requalification. It also enables studies to give an accurate measure of the degree of sanitisation achieved in terms of equivalence to a target log reduction that is relevant for decontamination instead of always effectively looking for the 6-log reduction that is only really relevant to terminal sterilisation.

Contact eXmoor here if you would like an impartial view in the section of decontamination techniques and qualification methods for the cell and gene therapy and related industries.

The R&D version of our novel CPrep equipment is now ready for trials. This equipment gently and automatically thaws and washes a cell therapy and then fills a syringe ready for administration.  It will help to extend the shelf life of valuable products, remove uncertainty in the final processing step and increase patient safety.

Commercially available CPrep has resulted from a joint project with Amercare Ltd, and a grant from the UK’s innovation agency, Innovate UK.  R&D versions may be trialled in our labs in Bristol and are manufactured by Amercare Ltd.  The supply chain for the GMP version will be finalised to suit the specific needs of individual cell therapies.

For more information see also CPrep – Cell Preparation and Contact Us to arrange a demonstration.

With support from Purplefish and Pinecone Design and McPherson Photography, we have updated our logo and online presence. Thanks to all of our team and client supporters for their input.

The 16th amc meeting, held on the 8th March in Manchester focusing on the new EU GMP for ATMPs, was sold out! The 17th Autumn meeting will be held on the 4th October in Cologne kindly hosted by Miltenyi Biotec. Keep a watch on the amc website for further details over the next couple of months.

Will Milligan (Exmoor bioprocess engineer) has been selected for the BIA MAC Bioproduction Leadership Initiative.

The programme was created to support the development of the next generation of bioprocess leaders, as part of BIA MAC’s objectives of connecting, advising and influencing. The development of managers in the biopharmaceutical and cell and gene therapy industries is an important part of the training landscape to deliver senior leaders of the future. Two key aims of the MAC initiative are:
1) to promote cross-sector learning by offering an overview of the work of other companies across biopharma, vaccines and cell and gene therapy by seeing them in action
2) to develop a network with peers to promote best practice

eXmoor cell therapy consultant Reinout Hesselink gave a presentation on Cost of Goods calculations, participated in a discussion on the relationship with a CMO and chaired the Cell, Gene and Immunotherapy Manufacturing, Process Automation and Cold Chain session at the last international CTM & GT Congress held in The Netherlands in Dec 2017.

Angela Osborne will speak at the Cell and Gene Therapy Manufacturing Workshop “Next generation manufacturing”. The event will take place at Guy’s Hospital, London, 14-15 March 2018. For more information click here

In memory of one of eXmoor’s founders, our nominated charity for 2017/8 is the Alzheimer’s Research UK.  https://www.justgiving.com/fundraising/runfordjd

Without effective treatments, one in three children born today will die with dementia. Today, there are no dementia survivors but research can change this.

Alzheimer’s Research UK is the world’s leading dementia research charity dedicated to causes, diagnosis, prevention, treatment and cure. Backed by our passionate scientists and supporters, we’re challenging the way people think about dementia, uniting the big thinkers in the field and funding the innovative science that will deliver a cure.

Our mission is to bring about the first life-changing dementia treatment by 2025.

With your support, we’ll focus our energies in four key areas of action to make this mission a reality.

  • Understand the diseases that cause dementia.
  • Diagnose people earlier and more accurately.
  • Reduce risk, backed by the latest evidence.
  • Treat dementia effectively.

Through these important strands of work, we’re bringing about breakthroughs that will change lives.