Archives for category: Manufacturing

MMIP plus logos

Ian McCubbin, Chair of the Medicines Manufacturing Industry Partnership, is stepping down from the role and reflects on the work achieved by MMIP over the past two years.

After two years of chairing the Medicines Manufacturing Industry Partnership (MMIP) I am now in the process of handing over to Andy Evans, the Head of AstraZeneca’s manufacturing site in Macclesfield. Andy has already thrown himself into the role during what is a very interesting time, for two main reasons.

Firstly, MMIP has really established credibility in the medicines manufacturing community, and with Government and associated organisations. In many ways I know that MMIP is seen as a role model for how we should work with government in the Life Sciences sector. It is also very timely following the vote to leave the EU and as Government starts to design the Industrial Strategy and the Life Sciences Industrial Strategy within that.

As I reflect on our contribution, it’s clear we have progressed significantly with a number of important topics, not least the Advanced Therapy Manufacturing Taskforce (ATMT). The Taskforce published its  action plan in November and, while awaiting an official Government response, we are already seeing progress with a competition to be opened in February for viral vector capability and hopefully other funds from the industrial challenge fund opening soon too. We have progressed how to close the skills gap and we are working very closely with the Department for Business, Energy and Industrial Strategy, Office for Life Sciences and the Department for International Trade on other actions.

Beyond the ATMT, MMIP continues to support the Medicines Manufacturing Innovation Centre and ADDoPT, both of which will contribute to medicines manufacturing innovation, and ultimately commercialisation and the sector’s contribution to the UK economy. The Medicines Manufacturing Innovation Centre will provide an open-access hub where medicines manufacturing stakeholders can collaborate, research and pull through emerging technologies and manufacturing processes into a commercial manufacturing environment. ADDoPT is the Advanced Digital Design of Pharmaceutical Therapeutics, it creates virtual medicine manufacturing systems to make sure they are effective and efficient before creating them in the real world.

With the support of The Association of the British Pharmaceutical Industry, BioIndustry Association, Innovate UK Knowledge Transfer Network and of course all the companies who have committed their valuable time and energy, MMIP has been able to create  momentum at exactly the right time. Some may say luck, but to paraphrase Gary Player, “The more we practice, the luckier we get.” I am very grateful to everybody who has generously thrown themselves into this project and I would urge anybody with a passion for the UK and medicines manufacture to find out more and to contribute to MMIP too.

I think Andy will do a great job as chair of MMIP and I am certain medicines manufacturing will form a very influential part in the future of the UK economy.

For more information about the MMIP, and how you can become involved, visit the MMIP webpage.

mac-leadership

As we gear up to this year’s BIA Committee Summit on 24 February, we’re taking a look at what some of our eight Advisory Committees have been up to. In today’s blog, Kit Erlebach, Deputy Chair of the Manufacturing Advisory Committee, details their bioproduction leadership initiative which launched in January.

On the 17th and 18th January, the BIA’s Manufacturing Advisory Committee (MAC) launched their Skills Networking Tour at FUJIFILM Diosynth Biotechnologies in Billingham. 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 recent action plan delivered by the Advanced Therapies Manufacturing Taskforce, co-chaired by Minister of State for Universities, Science, Research and Innovation, Jo Johnson MP and Ian McCubbin, SVP North America, Japan & Global Pharma Supply, GlaxoSmithKline, outlined the need for an end-to-end talent management plan to secure the relevant skills for emerging manufacturing technologies. This is an essential pillar to establishing the UK as the global hub of advanced medicinal therapy manufacturing and ensuring the long-term success of this industry in the UK.

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:

  • 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
  • to develop a network with peers to promote best practice

A total of 11 BIA member companies are currently taking part in the scheme: Allergan, the Cell and Gene Therapy Catapult, F-star, FUJIFILM Diosynth Biotechnologies, GE Healthcare, Lonza, MedImmune, Oxford BioMedica, Pall, Porton BioPharma and UCL.

As part of the project, the group of 11 participants (one representative from each of the above companies) will attend a series of site tours to offer an overview of the work of other companies in the sector by seeing them in action. Each site visit is preceded by a pre-dinner the night before, to encourage the development of a network of peers.

We were delighted to welcome 10 of the 11 company representatives involved in the tour to the FUJIFILM Diosynth Biotechnologies site in January. We had a detailed tour of two manufacturing facilities and parts of R&D. There were presentations on the site and company as well as the new potent molecule facility, some of the improvements undertaken and a career overview from one of the site leadership team.

The participants were very positive about the day and pleased to be part of the programme, giving some great feedback on the day. We look forward to continuing to develop the programme to deliver on the needs of BIA members and wider industry.

As we gear up to bioProcessUK this week, we have a belated Friday video from the Centre for Process Innovation (CPI), the UK’s national technology and innovation centre for the process manufacturing industries. At the National Biologics Manufacturing Centre, CPI combines state of the art facilities and technical expertise to support the growth and development of the UK biologics industry and supply chain.

Do you have a video you would like the sector to see? Contact us.

Watch this week’s video to see what the Cell and Gene Therapy Manufacturing Centre, currently under construction in Stevenage, will look like once it is opened in 2017.

To find out more about the centre visit the website.

Do you have a video you would like the sector to see? Contact us.

MMIP banner

This is the latest update on the Medicines Manufacturing Industry Partnership (MMIP) from Chairman, Ian McCubbin. If you have any feedback on the content or information here then please email us at MMIP@bioindustry.org. If you have any colleagues you feel would be interested in learning more about the work of MMIP then please ask them to get in touch with us or sign up to our mailing list here.

Manufacturing output data

Recent data from the ONS UK Index of Production shows that pharmaceutical manufacturing saw an 8.6% rise in April 2016, it’s largest rise since July 2012. However, the latest data shows a decrease of 6.5%. The overall increase is understood to be caused by increased exports. Work is ongoing to better understand the UK pharmaceutical sector’s footprint, the causes of the volatility and what can be done to ensure the UK medicines manufacturing sector continues to thrive in the future.

Advanced Therapies Manufacturing Taskforce update

The Advanced Therapies Manufacturing Taskforce held its second meeting of three on Tuesday 28 June. Since the last meeting each of the three workstreams (International Competitiveness, Skills and People, Manufacturing and Technology) have held workshops and other engagement activity to develop a series of prioritised actions for the Taskforce meeting to consider. Work is in progress to ensure buy-in from relevant stakeholders and Government departments. The final meeting will take place in November.

New ABPI Head of Manufacturing Innovation

The ABPI has recently appointed a new Head of Manufacturing Innovation. Dr Magda Papadaki joins from Innovate UK where she was Lead Technologist for the Regenerative Medicine program. She is a trained stem cell and gene therapy scientist and has over a decade of experience in research, with regulatory and business experience in the EU and US.

She joins the rest of the MMIP operational team including Neil Baker from Pfizer, Gregor Anderson from GSK, Ian Dick from GSK and David Garton from AstraZeneca (left to right below).

MMIP team

Open Funding calls from Innovate UK and H2020

The KTN MedBio team has produced a blog highlighting a number of Innovate UK funding calls which are relevant to the sector. If you are interested and would like support to apply for any of these opportunities then please contact Mark Bustard at the KTN (mark.bustard@ktn-uk.org).

MHRA Innovation Office supports Queen’s University Belfast

Queen’s University Belfast has been developing novel patches that are showing considerable promise as an effective and safe platform for transdermal drug delivery, as well as for minimally-invasive patient monitoring/diagnosis. MHRA Innovation Office’s latest case study, looks at how they helped QUB in preparing for the regulatory framework that will be the final step in bringing innovation to market.

Consultations

  • MHRA consultation on guidance for medical devices
    The Medicines and Healthcare products Regulatory Agency is asking for comments on its draft guidance for medicinal devices. This guidance is intended to be a useful resource on human factors and usability engineering principles, to clarify the expectations of the regulatory bodies. It is aimed at manufacturers of all device classes who intend to market their device in the UK. The consultation closes on 5 August.
  • IMI consultation on advanced therapies
    IMI has developed a concept paper on advanced therapies. The aim of the concept paper is to identify the potential of IMI as a platform for enhancing ATMP research and development. The deadline for submitting comments is 25 July 2016.

I hope you find this note of interest and we will continue to communicate and create a community of committed like-minded professionals who can help with MMIP. Please contact us at MMIP@bioindustry.org or join our LinkedIn group at http://bia.me/MMIP_LinkedIn. Likewise, if you have any colleagues you feel would be interested in learning more about the work of MMIP then please ask them to get in touch with us or sign up to our mailing list here.

 

MMIP banner

On the blog today, Ian McCubbin, Chair of the Medicines Manufacturing Industry Partnership (MMIP) introduces the Ministerial Advanced Therapies and Medicinal Products (ATMP) Manufacturing Taskforce. The Taskforce has been launched and held its first meeting, with a further meeting planned for June (see press release).

Introduction to the Taskforce

The Advanced Therapies Manufacturing Taskforce originated from the work of the Medicines Manufacturing Industry Partership (MMIP), it is co-chaired by George Freeman MP, Minister for Life Sciences, and by me, the Chair of the MMIP. It is a short-term group which will meet three times over 2016 with the aim of anchoring advanced therapy manufacturing and its associated supply chain in the UK. It will make a small number of targeted recommendations through an action and deliver plan to achieve this aim.

Taskforce membership

The group’s members include senior representatives from:

  • Office for Life Sciences
  • GSK
  • GE Healthcare
  • Pfizer
  • Astrazeneca
  • Cell and Gene Therapy Catapult
  • Centre for Process Innovation
  • Innovate UK
  • MRC
  • Institute for Manufacturing
  • MHRA
  • NHS Blood and Transplant
  • University College London
  • Oxford BioMedica
  • ReNeuron
  • Autolus
  • Cobra Biologics

Taskforce workstreams

The Taskforce has created three workstreams and appointed three leaders:

  • Technology and manufacturing (Keith Thompson, Cell and Gene Therapy Catapult)
    This workstream is looking at the current UK manufacturing position and considering a range of ideas from flexible grant and loan schemes to greater support infrastructure for companies.
  • People, skills & training (Jim Faulkner, Autolus)
    This is the most narrowly focused of the workstreams, it is looking at both training new people to enter the industry and repurposing existing skilled individuals to work specifically on ATMPs.
  • International competitiveness (Roger Connor, GSK)
    This workstream is looking at where intervention is required to support the UK’s ability to compete globally for manufacturing investment in advanced therapies. It is identifying where the UK is already strong and considering the UK’s process development capability, fiscal environment and the route to market for advanced therapies.

Next steps

The next meeting of the Ministerial Taskforce will be on Tuesday 28 June. At this meeting workstreams will submit initial proposals for recommendations to anchor advanced therapy manufacturing in the UK. After this meeting, details of a survey will be shared to ensure that the suggested actions reflect the views of the wider community. A final action and delivery plan will then be drafted ahead of the Taskforce’s third and final meeting on 2 November, with a release date for the plan and follow-up steps yet to be announced.

Get in touch

If you have any colleagues who would be interested in receiving updates on the work of the Taskforce or you would like to engage, then please get in touch with us by clicking this link.

 

MMIP update April 2016

Welcome to my first Medicines Manufacturing Industry Partnership (MMIP) update. Throughout 2016 we intend to share more of our activities as we build the medicines manufacturing community voice and promote the drive for growth of medicines manufacturing in the UK.

As a way to help us to connect with you and give more detail about what we do and our work, we have prepared with the Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association (BIA) and Knowledge Transfer Network (KTN) an MMIP overview leaflet which can be accessed here.

At the joint MHRA/ABPI Making the case for UK medicines manufacturing conference in early March, MMIP shared some of our 2015 successes such as:

We also shared the MMIP’s 2016 operating plan. This included work-streams focusing on Technology & Innovation, the Business Environment, the Regulatory Environment and Skills. The focus of these work-streams is on enabling growth in manufacturing as part of our end to end supply chains.

Ian McCubbin, Chair of MMIP, speaking at the ABPI/MHRA conference, "Making the case for UK medicines manufacturing"

Ian McCubbin, Chair of MMIP, speaking at the ABPI/MHRA conference, Making the case for UK medicines manufacturing

We see three groupings of medicines manufacturing, ‘small molecules’, ‘large molecules‘ and advanced therapies. In all of these, the end to end supply chain is critical to the manufacturing success. With this in mind, a ministerial taskforce has been set up, co-chaired by me and George Freeman, Minister for Life Sciences. This taskforce is focused on making recommendations to anchor the manufacture of advanced therapy medicinal products in the UK. It had its first meeting on Tuesday 22 March and more information will be coming soon on its terms of reference, scope and next steps focusing on manufacturing capability and technology, skills, and international competitiveness.

During my key note address at the conference, I outlined the challenge we face in the UK from competing regions. We already have a rich landscape of capability and infrastructure in the UK with national centres and renowned academic research but in an increasingly competitive world, we must offer more to encourage medicines manufacturing in the UK. In this respect, our regulator MHRA is a unique asset in supporting companies that have developed novel medicines or development approaches in their regulation.

I was very encouraged and excited by the alignment of industry, trade bodies and MHRA and the passion there is for the UK medicines manufacturing industry to succeed. We have many of the pieces of our jigsaw already available and with some effort and energy we can push them together to complete the picture and make the UK a more vibrant place to invest in medicines manufacturing.

Future sector MMIP events will be on Digital Design, Continuous Manufacturing and Patient Centric Packaging. We will contact you with more details on these and the opportunity to get involved.

I hope you find this note of interest and we will continue to communicate and create a community of committed likeminded professionals who can help with MMIP. Please contact us at MMIP@bioindustry.org or join our LinkedIn group at http://bia.me/MMIP_LinkedIn. Likewise, if you have any colleagues you feel would be interested in learning more about the work of MMIP then please ask them to get in touch with us or sign up to our mailing list here.

Ian McCubbin

Chairman, Medicines Manufacturing Industry Partnership

It’s been one year since Porton Biopharma Ltd (PBL) was commercialised out of Public Health England during the run-up to the general election. On the blog today, Dr Phil Luton, Commercial and Marketing Manager at PBL, explains more about the company’s history and its plans for the future.

It’s not often that a new company emerges fully formed with expertise in developing and licensing products both in Europe and the US, but that is exactly what happened just over a year ago with Porton Biopharma Ltd (PBL).

If you didn’t hear about it at the time, then don’t worry; your news feeds and industry alerts haven’t let you down. PBL was commercialised out of Public Health England (PHE) during the run-up to the general election; consequently, a soft launch was implemented, and the new company slipped almost silently into existence.

Of course, the “Porton brand” has been around for a century now, with the origins of the site dating back to the First World War; however, it was really in the 1960s that its scientists first started to look at harnessing microbes for healthcare. They were pioneers in developing continuous fermentation technology, the backbone of the modern biotechnology industry, and over the decades have worked with many different companies to help develop products as the sector grew.

That knowledge and expertise was also applied in-house, and Porton has taken its own products from the research lab, scaled them up, developed viable manufacturing processes (often ones requiring biocontainment, which is a particular expertise on site), and gained regulatory experience in multiple markets.

Porton Biopharma

Over the decades and often in response to global challenges from outbreaks of infectious diseases, wars, and other security threats, successive governments have shaped and changed the business model for the various organisations that have run the public health side of Porton. However, a significant strategic shift happened a few years ago with the appointment of Dr Roger Hinton as Director of Development and Production at what was then the Health Protection Agency (HPA). A key priority for Roger was to gain FDA licensure for Porton’s principle product, Erwinase®, an asparginase enzyme used in the treatment of Acute Lymphoblastic Leukaemia. That was achieved in 2011 and relicensed to a new partner (Jazz Pharmaceuticals) – it is now a life-saving biopharmaceutical available in nearly eighty countries around the world.

The next important strategic move was to consider how the manufacture of biopharmaceutical products fitted within the HPA, especially since a review of the future of research facilities at Porton was in process. By working with the Cabinet Office, the Department of Health and others, the formation of PBL was planned to enable it to remain on the Porton site where it could continue to supply the UK government with anthrax vaccine (a key strategic biodefence product) and work with its many commercial partners.

So PBL emerged on 1st April 2015, as a limited liability company with over 200 staff; still owned by the government but with a remit to continue to commercialise and grow its activities. Separately (later in 2015) there followed the announcement by the Chancellor of investment in new public health laboratories in Harlow, Essex, for PHE.

During the last year PBL has already grown by both increasing its head count and investing in its facilities, as demonstrated earlier this year with the opening of its new filling and freeze drying facility by Minister for Life Sciences, George Freeman MP. Whilst focusing on its key products, PBL is also looking to continue to work with the UK medicines manufacturing industry to offer help and assistance in developing, characterising and bringing to market new biological products, much as its predecessors have done over the decades.

SynpromicsThe explosion in the field of synthetic biology is causing ripples across the biotech industry. In today’s guest blog, David Venables and Michael Roberts of Synpromics, discuss the impact of synbio on another exciting area of biotech, gene therapy, by reducing the cost and increasing the scale and efficiency of viral vector manufacturing.

Synthetic biology is a relatively new discipline within the biotech industry, having leapt onto the scene only a decade ago, largely to address specific needs arising in the industrial biotechnology sector. There have been many definitions put forward over the years, but synthetic biology is broadly accepted as being the application of engineering principles to biological processes to improve and exploit them for commercial gain. A number of small start-ups are leading the field, and there is a strong entrepreneurial spirit akin to that seen in the IT sector. The vision is that all biological parts can be standardised and taken ‘off-the shelf’ to build complex biological systems that can be used to improve upon various industrial or, more recently, biomedical processes.

The synthetic biology landscape in Europe

The synthetic biology landscape in Europe, SynBioBeta

Synpromics is a synthetic biology company. We have IP and knowhow in the design of synthetic promoters – stretches of DNA just upstream of a gene that determine protein transcription/translation efficiency. Our synthetic promoters are designed to enable the controlled expression of genes under specific conditions: in a specific place or environment, or in response to a specific biological condition.

At the beginning of this year, we were delighted to announce a collaboration with the Cell and Gene Therapy Catapult, to remove a major barrier to the development of the cell and gene therapy industry by reducing the cost, and increasing the scale and efficiency of viral vector manufacturing. The collaboration will use our synthetic promoter design technology, and the Cell and Gene Therapy Catapult’s flexible manufacturing platform to create stable producer cell lines for the high titre and large scale manufacture of viral vectors. The work will be part funded by a £2m grant from Innovate UK.

Applications of synthetic biology

Applications of synthetic biology, SynBioBeta

Viral vectors are a crucial tool needed to modify patient’s cells to create a therapeutic effect. Established manufacturing platforms are limited by laborious processes, a lack of automation and low yields. This restricts the utility of viral vectors for the treatment of diseases where large amounts of virus would be needed, and has to date confined their use to local applications such as in the eye and to less prevalent indications, including orphan diseases.

This project will use synthetic biology to develop novel and controllable gene-expression promoters to drive the production of a much higher level of viral vector yield from new stable cell lines. This will allow the industry to produce vectors to much higher titres and with more efficiency, removing the current constraints associated with plasmid transfection of anchorage dependent cell lines.

For instance, these constraints particularly limit the manufacture of AAV-based viral vectors, where vector batches are currently produced from very low culture volumes (often only a few hundred litres). AAV is now the vector of choice in a number of clinical protocols as it mediates long-term gene expression, efficiently infects a number of different cell types and elicits a reduced immune response compared to previously used vectors. If AAV is to be widely adopted in the clinic then it is imperative that larger batches can be made in bioreactors to much greater scale (i.e. approaching tens of thousands of litres).

The project will run for three years, and will be focused on developing prototype cell lines to deliver industry relevant viral vectors, including Retrovirus, and Adeno Associated Virus. Synpromics will be responsible for the expression platform development with the Cell and Gene Therapy Catapult responsible for process industrialisation and control.

This will be the fifth major collaboration for Synpromics to apply our synthetic promoters in gene therapy. We believe Synpromics’ technology will provide a critically needed solution to high titre, industrial scale, vector manufacture, a critical barrier in the gene therapy industry. The result of this solution will be a major advance to the commercialisation of gene therapies in non-orphan drug indications.

Glythera-42Antibody Drug Conjugates (ADCs) are monoclonal antibodies attached to biologically active drugs, often developed for use in the treatment of cancer. In today’s blog, Dave Simpson, Glythera CEO, discusses the rapidly growing pipeline of ADCs and the ever increasing demand for manufacturing capacity.

During the past decade the ADC pipeline has grown significantly from only eight distinct ADCs in clinical development in 2008 to over 60 in 2016. Whilst early targets were primarily focused towards the treatment of haematological disorders, the generation of newer ultra-potent toxins and, more recently, improved tumour penetration through alternative scaffolds has accelerated the growth in ADC discovery programmes, especially for the treatment of more difficult to treat solid tumours. This expanding pipeline has been mirrored by an increasing number of majors with an ADC focus as well as need for capability to manufacture.

ADCs are, by their very nature, complex entities, combining antibodies (whole or fragments) with potent toxins via conjugation chemistries and appropriate linkers. Even with the anticipated US $1 billion sales generated by the two currently approved ADCs Adcetris® and Kadcyla® and the rapid expansion of the field, relatively few innovators have elected to manufacture ADCs in-house with over 70% outsourcing their manufacturing to contract manufacturing organisations (CMOs).

Manufacturing houses require both biological capability and high containment cytotoxic facilities designed to handle compounds which have a very low Occupational Exposure Limits (OEL) – whilst maintaining aseptic and GMP compliance.

Glythera-371

Over the last 5 years, the CMO market has shifted dramatically from the manufacturing of blockbusters to specialist care drugs. Given the complexity of ADCs, there is a real prospect for manufacturing-oriented companies to offer specialised services through the provision of innovative solutions to current manufacturing challenges – and this, in turn, demands a highly skilled work force.

On top of the challenges of manufacturing drug substance for a selected antibody, plus a range of linker/payload chemistries, manufacturers face difficulties in generating homogeneous ADC and fill/ finish for the subsequent combination. Significant investment has been made by established CMOs and specialised services providers have emerged to support manufacturing by way of partnered supply chains or “one stop shops”.

With global revenues for contract manufacturing services estimated to reach US $60 million by 2018 – and ADC manufacturing anticipated to represent US $1 billion within the next decade – significant investments have been outlaid for facility expansion and to access broader services through mergers and acquisitions by established CMOs including Lonza, Piramal, Carbogen-Amics and Catalent.

Others have preferred to streamline their manufacturing process whilst broadening their potential client base and their manufacturing repertoire through supply chain partnerships. For example, FUJIFILM Diosynth Biotechnologies and Baxter BioPharma Solutions have signed up with Piramal and SAFC® respectively.

We have also seen the emergence of specialist service providers who support development and, perhaps more critically, provide a cost effective, compliant supply chain for early stage clinical trial material. In the UK Abzena, (formed through the combination of Polytherics and Antitope, and the subsequent acquisition of Pacific GMP and TCRS) has positioned itself as supporting a “bench to bedside” approach to ADCs including cell line development, ADC development and subsequent GMP manufacturing.

Glythera-445Thus, the development of ‘problem solving’ manufacturing platforms has underpinned the opportunity for companies to support ADC development and manufacturing. ADC Biotechnology was founded on proprietary technology which focussed on reducing ADC aggregation during manufacturing, therefore improving product safety profiles whilst accelerating ADC development programme timelines. The Company has recently announced significant investment to allow for the expansion of its facilities and capabilities, including GMP manufacturing of this important – and complicated – product class.

With the continued expansion of the clinical pipeline, the expectation of further approvals and the market opportunity for manufacturing of ADCs, there is no doubt that the industry will continue to see further increase in supply chain partnerships and investment into the expansion of current CMOs including those based within the UK.

Glythera is focussed on the development of next-generation ADCs underpinned by its proprietary conjugation/novel toxin platforms. The company was spun out from Bath University in 2007 and relocated to Newcastle upon Tyne in 2012, through ongoing investment support from IP Group and the North East Technology Fund.