Guidance

Medicines manufacturing

Updated 1 December 2021

Introduction to medicines manufacturing

Tomorrow’s medicines will demand an ever closer integration of development science and technology with manufacturing. The UK is the place to make them. The UK has a long track record of cost-effective and compliant medicines manufacturing from leading global companies and has specialised national networks in high value manufacturing (HVM).

Numerous UK organisations give support, advice or useful information for each development stage of medicines manufacturing.

Discovery and deep research development stage: UK support organisations

Bioprocessing Research Industry Club (BRIC)

BRIC is a partnership between BBSRC, EPSRC and a consortium of leading companies to support innovative bioprocess-related research, including that needed for the manufacture of complex biopharmaceuticals.

BRIC funded research addresses bioprocesses at all scales of operation, from the small amounts required for preclinical studies through to post-license bulk manufacturing.

Biotechnology and Biological Sciences Research Council (BBSRC)

BBSRC is part of UK Research and Innovation, a new body which works in partnership with universities, research organisations, businesses, charities, and government to create the best possible environment for research and innovation to flourish.

Engineering and Physical Sciences Research Council (EPSRC)

The EPSRC is the main funding body for engineering and physical sciences research in the UK, investing in research and postgraduate training. Its portfolio covers a vast range of fields from healthcare technologies to structural engineering, manufacturing to mathematics, advanced materials to chemistry.

EPSRC is part of UK Research and Innovation, a new body which works in partnership with universities, research organisations, businesses, charities, and government to create the best possible environment for research and innovation to flourish.

EPSRC Centres for Innovative Manufacturing has 16 centres for innovative manufacturing including:

• continuous manufacturing and crystallisation (CMAC)
• emergent macromolecular therapies
• medical devices
• regenerative medicine

Each centre can be used as a platform for organisations to invest in. They all:

• develop collaborations
• carry out feasibility studies
• supports research projects

Medical Research Council (MRC)

The MRC improves human health through world-class medical research. It funds research across the biomedical spectrum and its research has resulted in life-changing discoveries for over 100 years. Its work ranges from laboratory research, for example on genes and molecules, right through to clinical trials and population studies.

MRC’s science is split into 6 broad areas of research which includes:

• infections and immunity
• molecular and cellular medicine
• neurosciences and mental health
• population and systems medicine
• global health
• translational research

Its research is carried out in universities, hospitals and a network of dedicated establishments across the UK and Africa.

National Biologics Manufacturing Centre (NBMC)

NBMC was established by the Centre for Process Innovation (CPI), the UK’s national technology and innovation centre for the process manufacturing industries. CPI combines state of the art facilities and technical expertise to support the growth and development of the UK biologics industry and supply chain. They help companies de-risk process development through proof of concept testing to accelerate the commercialisation of new processes and technologies.

Development and translation development stage: UK support organisations

Catapults

The catapult centres are a network of world-leading centres designed to transform the UK’s capability for innovation in specific areas and help drive future economic growth. The catapults include:

• cell and gene therapy
• digital
• high value manufacturing
• medicines discovery
• precision medicine

The Cell and Gene Therapy Catapult:

• accelerates delivery of therapies to the patient
• works with industry to take products into clinical trial, de-risking them for further investment
• provide technical and regulatory expertise to ensure products can be made to good manufacturing practice and get to the clinic safely in the shortest time
• provide opportunities for collaboration and access to NHS clinical partners and expertise networks

The High Value Manufacturing Catapult has 7 technology and innovation centres. They work with companies of all sizes to bridge the gap in – and accelerate the activity between – technology concept and commercialisation. Their centres offer access to leading edge equipment, expertise and an environment of company collaboration.

Medicines Discovery Catapult supports industry in developing new technologies primarily for the discovery and evaluation of medicines.

Centres for Doctoral Training (CDT)

The EPSRC funded centres bring together diverse areas of expertise to train engineers and scientists with the knowledge and confidence to tackle today’s evolving issues.

Clinical Practice Research Datalink (CPRD)

CPRD is a governmental, not-for-profit research service. It’s jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare Products Regulatory Agency (MHRA), part of the Department of Health and Social Care (DHSC). CPRD has been providing anonymised primary care records for public health research for 30 years.

This data enables:

• observational studies
• clinical trial feasibility and protocol optimisation
• post-market surveillance

Innovate UK

Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive science and technology innovations. Innovate UK fund the strongest opportunities and connect innovators with the right partners they need to succeed.

Innovate UK Knowledge Transfer Partnership is Europe’s leading programme helping businesses to improve their competitiveness and productivity through the better use of knowledge, technology and skills that reside within the UK knowledge base.

Knowledge Transfer Network (KTN)

KTN is the UK’s innovation network. It connects people to speed up innovation, solve problems and find markets for new ideas.

The KTN Health Community connects organisations to catalyse innovation. It’s dedicated to accelerating innovation and technology exploitation in the health industries sector in the important areas of medical, biotechnology, medical technology, diagnostics and pharmaceutical industries.

Regulatory and health technology assessment development stage: UK support organisations

British Standards Institute (BSI Group)

BSI is the UK national standards body. Using standards BSI help companies comply with regulations and standards, avoid product failures and recalls to help enter new markets.

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA is the UK’s regulatory agency responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Robust and fact-based judgements underpin all the work carried out to ensure that the benefits justify any risks.

MHRA Innovation Office is a single point of access to expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes develop innovative medicines, medical devices or novel manufacturing processes. They provide expert knowledge, guidance and experience to help develop products and save time and money.

National Institute for Biological Standards and Control (NIBSC)

NIBSC is a global leader in the characterisation, standardisation and control of biological medicines. It plays a major role in assuring the quality of biological medicines worldwide:

• through the provision of biological reference materials
• by testing products
• by carrying out research

National Institute for Health and Care Excellence (NICE)

NICE publishes guidance in 4 areas including the use of:

• health technologies within the NHS
• new and existing medicines, treatments and procedures

Scottish Medicines Consortium (SMC)

The SMC accepts for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. It analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price.

The consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry and the public.

Delivery, supply and NHS / patient development stage: UK support organisations

Academic Health Science Networks (AHSNs)

The AHSNs facilitates access into the NHS and aligns education, clinical research, informatics, innovation, training and healthcare delivery providing a network aimed at supporting the adoption and dissemination of innovative technologies.

There are 15 AHSNs across England, and each AHSN works across a distinct geography serving a different population in each region.

National Health Service (NHS)

The NHS, launched in 1948, is the largest unified healthcare system in the world. It treats almost 1 million patients on a daily basis. It was born out of a long-held ideal that good healthcare should be available to all, regardless of wealth and remains free at the point of use for anyone who is a UK resident. That is currently more than 64.6 million people in the UK.

NHS England sets the priorities and direction of the NHS in England. It shares out more than £100 billion in funds in the commissioning of health care services in England and holds organisations to account for spending this money effectively.

NHS Scotland is the publicly funded healthcare system in Scotland. Health and social care policy and funding are the responsibility of the Health and Social Care Directorates of the Scottish Government. NHS Scotland currently employs approximately 140,000 staff who work across 14 territorial NHS Boards, 7 Special NHS Boards and 1 public health body.

NHS Northern Ireland provides the gateway to Health and Social Care Services in Northern Ireland, and links to the Hospital and Community services provided by the 6 Health Trusts, General Practices, Health and Social Care Board and other HSC Agencies. The Northern Ireland Executive, through its funding of the Health Department is responsible for the funding of the service.

NHS Wales is the official corporate name of the Welsh National Health Service, the publicly funded healthcare system which is the responsibility of the devolved Welsh Government. There are 7 Local Health Boards (LHBs) in Wales and 3 national NHS Trusts. Each LHB is responsible for delivering all NHS healthcare services within a geographical area. Three NHS Trusts, called ‘all-Wales trusts’, operate nationwide agencies and services.

NHS procurement

There are several routes to market for companies interested in supplying goods and services to the NHS.

Read more on Partnering with the NHS to sell goods and services.

Scottish Medicines Consortium (SMC)

The SMC accepts for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. SMC analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price. The consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry and the public.

Launch global access development stage: UK support organisations

Department for International Trade (DIT)

DIT is the government department that helps UK-based companies succeed globally and assists overseas companies to bring investment to the UK. DIT’s network of government and private-sector specialists, in the UK and in British Embassies and Consulates throughout the world, offers practical advice and free and confidential support.

Life Sciences Organisation (LSO)

The LSO helps UK life science companies do business overseas and encourages foreign life science companies to invest in the UK. It provides support from the earliest stages of research and development through to clinical trials, commercial operations and business partnerships.

Healthcare UK

Healthcare UK is a joint initiative of DHSC, DIT and NHS England.

Healthcare UK helps UK healthcare providers do more business overseas by:

• promoting the UK healthcare sector to overseas markets
• supporting healthcare partnerships between the UK and overseas healthcare providers

NICE Office for Market Access (NICE OMA)

NICE OMA provides expert advice to the life sciences industry on pharmaceuticals, health technologies, diagnostics, and devices.

They advise on:

• NICE processes
• how to work with NICE to achieve your aims
• how NICE links with different parts of the system
• the Early Access to Medicines Scheme (EAMS) and how NICE supports it

UK life science membership associations and networking organisations

Find UK life science membership associations and networking organisations who can aid business growth, competitiveness and innovation in the life sciences sector.