MAC supports the UK commercial bio-medicine manufacturing community by providing an experienced network for members to address issues relevant to the biologics, vaccine, cell and gene therapy sector, to cross-pollinate expertise and best practice.
MAC has a significant presence on the Medicines Manufacturing Industry Partnership (MMIP), which reports at Ministerial level, bringing the whole UK industry together to drive UK competitiveness in medicines manufacturing, along with theresulting Advanced Therapies Manufacturing Taskforce. The committee is networked into Catapults and UK Centres of Excellence.
The committee has reviewed and responded to a number of manufacturing-related consultations from the European Commission and contributes to the MHRA GMP/GDP Consultative Committee.
- 33 members spanning biologics, vaccines and cell & gene therapies cross-pollinating expertise and best practice through networking and site visits
- Network through site visits, seminars, committee socials and engagement with KTN
- Deliver another successful programme for the 2020 bioProcessUK conference
- Contribute to the 2020 UK Bioscience Forum
- Aid in setting out a national skills provision for biomanufacturing for global impact:
- Expansion of the very successful ISCF funded ATAC programme led by CGT Catapult
- Leadership skills delivery through the popular BIA MAC LeaP initiative
- Key pan-industry stakeholder within Life Sciences Industrial Strategy:
- Several MAC members represent the voice of the biologics/cell and gene therapy sector on the MMIP Leadership Team, seeking wider MAC contribution when appropriate
- Set next generation analytics and associated data strategic vision for industry
- Ongoing role in anchoring ATMP manufacturing for early phase academic-led clinical trials in the UK
- Represent BIA at the MHRA GMP/GDP consultative committee meetings
- Input into Brexit consultations and identify regulatory advatages where possible
BIA MAC Leadership Programme (LeaP)
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 BIA initiative to support this, as part of MAC’s objectives of connecting, advising and influencing, are firstly to promote cross-sector learning by offering an overview of the work of other companies across biopharma, vaccines and cell and gene therapies by seeing them in action; and secondly to develop a network with peers to share best practice and develop relationships to encourage possible future collaborations. The pilot programme was launched in January 2017 and completed in January 2019, following which an alumni group has been set up to support ongoing networking. On the back of the success of the pilot, a second programme is well underway, starting in January 2018, and a third double cohort started in January 2019. Currently 44 participants from 23 member companies are benefitting from LeaP.
Why not read the blog from Roger McGilvray of Adaptimmune, discussing how LeaP members learnt from manufacturing in the automotive sector during their visit to the BMW Mini Plant in Oxford; or the blog from Ricky Casey of GSK on their visit to Airbus Space & Defence in Stevenage; or Louise Taylor of CPI's account of their site visit.
Advanced Therapies Apprenticeship Community (ATAC)
Advanced therapies have the potential to address significant and growing unmet healthcare needs. They offer the promise of treating and altering the course of diseases which cannot be addressed adequately by existing pharmaceuticals. The UK is at the leading edge of this disruptive industry and there is an opportunity to build a large-scale industry delivering health and wealth.
The Advanced Therapies Apprenticeship Community (ATAC) has been established in partnership with MMIP to develop the first apprenticeship programme designed specifically to train and upskill individuals to develop, manufacture and deliver these innovative therapies at scale.
MAC supports this programme, led by the Cell and Gene Therapy Catapult. Full details can be found on the ATAC website
Next Generation Analytics
BIA MAC, in partnership with the Cell and Gene Therapy Catapult & KTN, held a workshop in June 2019 to discuss key challenges, barriers and opportunities for the development and integration of analytical technologies to support advanced manufacturing. The workshop, which was attended by representatives from large pharma, biopharmaceutical SME’s, technology developers, national measurement laboratories, RTO’s and CDMO/CRO’s discussed what analytical innovation is needed to accelerate growth within the industry. The resulting paper summarises four key recommendations.
Committee Chair: Dr Kit Erlebach, Strategic and Transformational Venture Manager, FUJIFILM Diosynth Biotechnologies
Committee vice-Chair: Sharon Grimster, VP Development and General Manager Wales, ReNeuron
For more information contact Netty England, Bioprocessing Consultant
Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.
Our proprietary SPEAR T-cell platform has generated a strong pipeline of affinity-enhanced T-cell therapies, with multiple INDs open. We use these therapies to harness the body's own immune system to find and destroy diseased cells. Our SPEAR TCR therapies offer promise to patients that often have no other options. We are working hard to make that promise a reality.
Advanced Centre for Biochemical Engineering, University College London
The Advanced Centre for Biochemical Engineeering hosts the MBI® Modular Training Programme for the Bioindustries.
Allergan Biologics Ltd
Allergan Biologics Ltd. (an affiliate of Allergan plc.) is a state of the art development and clinical manufacturing facility and is a Centre of Excellence for Biologics development.
AstraZeneca is a major contributor to UK science and innovation investment, economic prosperity and to patient health. The UK is home to the organisations global headquarters and major research and development and manufacturing facilities. AstraZeneca invest over £1.3 billion per year in research and development in the UK.
Asymptote specialises in cryopreservation and liquid nitrogen-free freezers developed for GMP compliant cold chains for regenerative medicine and biobanking
BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures.
Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation.
Cellular Therapeutics Ltd
Cellular Therapeutics is focused on “Personalised cellular medicine” using the patient’s own immune system to be harnessed in order to fight disease.
Centre for Process Innovation
The Centre for Process Innovation is a UK-based technology innovation centre and part of the High Value Manufacturing Catapult.
Clinical Biomanufacturing Facility, Oxford University
The Clinical BioManufacturing Facility is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility.
Cobra provides a comprehensive biopharmaceuticals service offering, with multi-functional project teams nurturing products from pre-clinical to commercial scale GMP manufacture.
Envigo is one of the world's largest Contract Research Organisations.
eXmoor Pharma Concepts Ltd
eXmoor pharma is a technical and strategic consultancy in biopharmaceuticals, secondary pharmaceuticals and cell & gene therapies. We work in capital projects and GMP biomanufacturing.
Freeline is a leading clinical-stage biotechnology company. We focus on development and commercialisation of innovative gene therapies to change lives.
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Manufacturing Organisation with locations in Billingham, UK and Research Triangle Park, North Carolina, USA.
GE Healthcare UK Ltd
GE is a global infrastructure, finance and media company taking on the world's toughest challenges.
GSK is a global pharmaceutical company dedicated to helping people feel better, do more and live longer.
Horizon is a revenue-generating life science group supplying research tools to organizations engaged in translational genomics research and the development of personalized medicines.
Innovate UK is part of UK Research and Innovation, a non-departmental public body funded by a grant-in-aid from the UK government.
Ipsen Biopharm Ltd
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2010
Lonza Biologics plc
As a worldwide leader supplying the pharmaceutical and biotechnology industries with biopharmaceuticals, Lonza furnishes seven different markets with state-of-the-art products, services, and research.
NHS Blood and Transplant
The Clinical Translation Partnerships (CTP) was established in 2010 to support scientists bringing new cellular therapies into clinical practice.
Nightstar is a private biopharmaceutical company, funded by Syncona LLP, an independent subsidiary of the Wellcome Trust, focused on the development of therapies for retinal dystrophies.
Oxford BioMedica plc
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs.
Pall Life Sciences
Pall Corporation (NYSE:PLL) is a global leader in the high-tech filtration, separation and purification industry. We’ve become an industry leader by helping a diverse range of customers solve complex fluid management challenges.
Puridify offers purification solutions for biotherapeutic manufacturing. Our flagship product, FibroSelect, reduces biotherapeutic manufacturing costs by c.25%.
Purolite is the only globally-acting company that focuses exclusively on advanced resin technologies and has been producing resins for over 35 years.
ReNeuron Group Plc
ReNeuron are a leading, clinical-stage stem cell business. Our primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
Roslin Cell Therapies
Roslin Cells are world leaders in the isolation of new clinical grade pluripotent stem cells for use in research and therapy.
TAP Biosystems (TAP) is an innovative UK company providing automation systems and services to improve productivity in life science research, development and production.
TAP design, develop and support advanced cell culture and processing systems with applications in regenerative medicine, bioprocess development, biologics production and drug discovery. We also provide custom automation solutions for cell therapies, bioprocessing and sample management.
Recent innovations include a novel microscale bioreactor and a collagen-based 3D tissue modelling system.
TCR2 is a clinical-stage immunotherapy company developing a new generation of T cell therapies for patients suffering from cancer.
Thermo Fisher Scientific
Thermo Fisher Scientific is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.