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Coming soon: Call for Proposals in Biopharma Manufacturing Analytical tools under Innovative Medicines Initiative IMI2 – Call 10

By Mike Snow

Coming soon: Call for Proposals in Biopharma Manufacturing Analytical tools under Innovative Medicines Initiative IMI2 – Call 10

All you ever wanted to know but were too afraid ..too busy.. to ask’

KTN understands from the IMI stakeholder Forum in September that we should expect the launch of Call 10 towards end October with webinars around the same time. The topic is of particular interest as it aligns well with our strong UK sector, both in academia and industry.

What is IMI?

The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients.

IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. The goal of the IMI, particularly in its second phase (2014-2024) is to develop next generation vaccines, medicines and treatments.

What will Call 10 include?

Call 10 highly likely to include the topic titled ‘Biomanufacturing 2020: Development of innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture process’.  The key objectives for the call are to: To develop/determine the best high throughput methods, novel analytical methods and feedback control methods to be used during the manufacturing of biopharmaceuticals, in particular the cell culture. 

Full details for this topic are detailed in this paper and at the IMI stakeholder forum, Colm Carroll of IMI gave us the headlines (still indicative at this stage) in his slides - I summarise these at the end of this article.  

A ‘sweet spot’ of a topic and timing for the UK?

So while putting together an IMI consortium is not for the fainthearted, the UK should pay attention to this topic in particular. We have a strong industrial sector in this space alongside leading academic institutions – the KTN’s Biopharmaceutical Formulation Group and Biopharmaceutical Analytical Group have grown year on year - last year’s annual analytical meeting hosted by the National Biologics Manufacturing Centre was a very vibrant 2 day affair, with a focus also on advanced therapies provided by Cell and Gene Therapy Catapult. KTN’s medicines manufacturing portal at http://www.mmlandscape.ktn-uk.org gives an overview of the sector. We’ve recently had a series of projects funded through high value manufacturing area of Innovate UK. BioPRONET is a growing academic-led network that encompasses this topic, their annual meeting aligns also with BRIC, the Bioprocessing Research Industry Club.

Getting a consortium together, getting involved

I picked up at the forum that key to getting involved is through the tools of the trade we would all be familiar with:

·      using your own network of contacts

·      engaging early through the call webinars as soon as they are announced.

·      Sign up and use the IMI participant portal to find partners/flag your profile

·      Use the bodies funded to support you such as EEN, NCP, Innovate UK, Research Councils etc – and KTN will facilitate and signpost

Why bother?

The winning consortia not only receive large amounts of funding, but a long term relationship brings many other benefits - a key message at the meeting was ‘its not about the money’ its about the collaborations fostered and longer term outcomes. The UK has succeeded in IMI across the board from academic institution to SME – ABPI ‘s report available on their website shows this very nicely.  Some quick takeaways- of those receiving the most IMI funding,  3 out of the top 10  EU SMEs are from the UK, 5 out of the top 10 are UK of EU academic institutions. So we have a base of success and knowledge of relevant consortia members to build out from.

Call Objectives

·      High-throughput methods

o   Miniaturisation & automatic sample prep to enable fast testing

·      Novel methods

o   Novel technologies for online non-invasive testing, such as spectrophotometric methods to test cell culture conditions.

·      Feedback control methods

o   Automated controls for the control of manufacturing operations. §

·      Data Management Tools

o   Development of data management tools l to maximally explore datasets generated during the project.

Expected impact

The validated innovative analytical tools developed in the project will:

·      Allow for more effective control and execution of the production phase of biopharmaceutical therapies.

·      Lead to consistent quality.

·      Increase supply chain reliability and reduce drug shortages.

The developed analytical tools will be immediately ‘fit for use’ in the manufacture of Advanced Therapies Medicinal Products (ATMPs)

(Note the link to ATMPs- next article to follow for more info on this opportunity for later calls in IMI)

Expectations from applicant consortium

Specialists in:

  • high-throughput screening assays
  • ‘omics’ method development
  • management, interpretation and modelling of complex data sets
  • development and manufacturing of online probes and of devices for aseptic at-line sampling and rapid sample preparation.

Have the expertise to:

·      develop automated highly-sensitive measurement tools & methods

·      develop high throughput tools to measure product quality attributes

·      develop innovative micro-Scale Fed-Batch Cultures

·      develop rapid spectrophotometric methods for cell culture monitoring

·      develop process analytical technology for biopharmaceutical products

Where can I find out more about current projects and consortia?

Projects listed here: http://www.imi.europa.eu/content/ongoing-projects

Here are a few we’ve picked out :

- STEMBANCC – aims to provide well characterised patient derived induced pluripotent stem cell lines and associated biomaterials in an accessible and sustainable bio-bank; strong number of UK members in the consortium from academia and large pharma, Total project costs 55.6 m euros.

- European Bank for induced pluripotent Stem Cells -Roslin Cells, now Censo Biotechnologies, and Definigen are notable among UK SME participants in this consortium. Total project costs of 35m euros.

European Lead Factory is a pan-European platform for drug discovery, Comprising a collection of half a million compounds (derived from new public and existing private company collections) and a screening centre, total costs: over EUR 190m.

ENABLE – colleagues in European Biotechnology Network worked with members on this call and successfully won this consortium within which REDX pharma and Molecular Discovery Ltd are among the UK members, The ENABLE project, the third within the ND4BB series, spans 13 countries and brings together 32 partners with the mission to establish a significant anti-bacterial drug discovery platform for the progression of research programmes through discovery and Phase 1 clinical trials. €85 million

Support for consortia building- as an academic you can put forward for support for costs from MRC if you are going to participate in a consortium: http://www.mrc.ac.uk/research/international/innovative-medicines-initiative/

BW, and good luck.  Sarah Goulding, KTN