EHDA Network-Pharmaceutical EHDA Technology: Developing QbD Facilitated, Continuous and Scaled Therapy Enabling Platforms

Lead Research Organisation: De Montfort University

Abstract

Advances in fit for use manufacturing of biopharmaceutical drug delivery and pharmaceutical systems are now required to fit Quality by Design (QbD) models. These current regulations require excellence to be built into the preparation of emerging products (both material and process) thereby leading to product robustness and quality. In addition, industrial needs (economical and reproducible quality enhancement) are driving manufacturing towards continuous processes over batch type processes which also rely on QbD (for integrity and quality). EHDA technology is a robust process that has been utilised in various formats (e.g. electrospinning, electrospraying, bubbling and even 3D printing) and is favourable due to applicability with the development of stable nanomedicines and biopharmaceuticals, the emergence of this technology is clearly evident in the UK and on the global scale. Attempts in scaling up (for suitable pharmaceutical scale) and in tandem with continuous processes (including controlled manufacturing) have been very limited. There also, now, remains a huge void in the adaptation of sensible QbD (multi-variate) for the current methods developed and also those required by industry. While lab scale research continues with the ongoing development of such processes (e.g. nanomedicines, smart and controlled delivery), the transition to industry or the clinic will have to meet these regulations (and scales) for there to be a real impact, which is now, also, an important aspect of grass root research in the UK.

The EHDA network brings together specialists from academia and industry to advance this technology through several means. Firstly, initiating developments towards a real-viable scale for Pharmaceutical production. Secondly, to incorporate developments in lean manufacturing and legislation (e.g. continuous manufacturing, online diagnostics, QbD and adaptable scale). Thirdly, to marry optimised lean technologies with novel and emerging macromolecular therapies and actives. The network has a wide range of activities and initiatives which will lead to significant developments (and collaborations) in an area of increasing global interest (EHDA processes) - but currently only on a viable lab scale to date. This network will be the first of its kind and will serve as the central and pioneering hub in this remit.

Planned Impact

This EHDA network will give rise to several initiatives (QbD, continuous processing and scale-up) which are meeting the needs of industrial manufacturing and much needed improved and novel therapeutic delivery. EHDA technologies already present desirable options in ambient condition preparation of pharmaceuticals, non-destructive preparation of biopharmaceutics (especially macromolecules) due to low energy processes, controlled encapsulation (layering, compartmentalisation and multi-coating thickness control on the nano and micron scales). In addition, improving solubility of emerging active chemicals (most of them poorly soluble) and offering morphological variations (fibres, particles, bubbles, capsules etc) while maintaining the aforementioned properties are also key factors for industry. Combining all these benefits will therefore significantly improve drug delivery science as well as reducing overall manufacturing costs, increasing efficiency, bringing new technologies to suitable production rates and meeting regulatory needs for impact case fruition (see letters of support from GSK, GEA Pharma, VolitionRX, Oncalytica and UCL-EMT).The impact of this work will also be crucial to pharmacists, pharmaceutical industries and scientists and the public in general, although other industries will also benefit where precision control on manufacturing is highly desirable.
 
Description DMU PhD Scholarships
Amount £60,000 (GBP)
Organisation De Montfort University 
Sector Academic/University
Country United Kingdom
Start 09/2017 
End 09/2020
 
Description Royal Society Industry Fellowship with BlueFrog Design
Amount £118,000 (GBP)
Organisation The Royal Society 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2016 
End 09/2020
 
Description Collaboration with Elvesys- Paris 
Organisation Elvesys
Country France 
Sector Private 
PI Contribution We have initiated a collaboration between De Montfort University and Elvesys in Paris. We have discussed a few EU projects and we are in the process of preparing for an ITN, Marie Curie bid. We visited the Elvesys centre in Paris and presented work and efforts of the EHDA Network
Collaborator Contribution They accommodated us in Paris. Gave us a tour of their facilities and also demonstrated what current projects they were interested in.
Impact none at present
Start Year 2017
 
Description Collaboration with Prof Santiago Ruiz Gomez, Universidad Rey Juan Carlos (met at previous Conference) 
Organisation King Juan Carlos University
Country Spain 
Sector Academic/University 
PI Contribution Visited the new University and had lunch with whole Department. Presented some of the EHDA Technologies we are developing. Discussed some emerging proposals or options.
Collaborator Contribution Tour of facilities. Presentation of their capabilities. Discussion of what materials they could provide to the collaboration. Recepton.. Agreed on some materials when needed at DMU.
Impact none yet
Start Year 2017
 
Description Collaboration with University of Twente- Prof. Vancso 
Organisation University of Twente
Country Netherlands 
Sector Academic/University 
PI Contribution Visited the Polymer Engineering Department and had tour of facilities. Discussed a previous ETN bid and re-evaluated with Prof Vancso. Proposed a new project for collaboration on EHDA technologies. Presented some of our recent work and capabilities
Collaborator Contribution Tour of facilities, Proposed selection of polymers and use of their facilities. Lunch reception with group members. Provided with further details of other links and contacts working with Prof. Vancso to include in further collaborations for EU bids
Impact none
Start Year 2017
 
Description De Montfort University (Zeeshan Ahmad) and Ashland Specialist Ingredients 
Organisation Ashland
Department Ashland Speciality Ingredients
Country United States 
Sector Private 
PI Contribution Application of QbD Models and EHDA Engineering Techniques
Collaborator Contribution New Polymeric Materials and expertise in polymer design for drug delivery
Impact This project is only underway
Start Year 2016
 
Description De Montfort University and Blue Frog Design 
Organisation BlueFrog Design
Country United Kingdom 
Sector Private 
PI Contribution We (Zeeshan Ahmad, De Montfort University) is contributing knowledge and concept ideas relating to EHDA Technology
Collaborator Contribution Blue Frog Design is contributing pharmaceutical engineering product know how and product design expertise
Impact This has only just started and is a funded project by the Royal Society There is also support from De Montfort University (fully funded studentship)
Start Year 2016
 
Description De Montfort University and Genvolt 
Organisation Genvolt Ltd
Country United Kingdom 
Sector Private 
PI Contribution Concept design for EHDA Technologies
Collaborator Contribution Development of new High Voltage supplies to meet the needs of the pharmaceutical Industry
Impact Initiated in 2016
Start Year 2016
 
Description De Montfort University and SympaTech 
Organisation Sympatec
Country Germany 
Sector Private 
PI Contribution Utilising EHDA Technology to fit into the sizing process
Collaborator Contribution Development and advanced analysis of live sizing
Impact THis has just been initiated
Start Year 2017
 
Description De Montfort University and Thessaloniki Pharmacy Greece 
Organisation Aristotle University of Thessaloniki
Country Greece 
Sector Academic/University 
PI Contribution Advanced EHDA methods with optimised processing
Collaborator Contribution Technological advancement using ex-vivo barriers
Impact This collaboration is yielding data and we are seeking to publish two further articles from this. In addition there is an expectation to submit two EU grant bids.
Start Year 2016
 
Description De Montfort University and Umetrics 
Organisation Umetrics
Country Sweden 
Sector Private 
PI Contribution Expertise in EHDA Technology and parameter design
Collaborator Contribution Expertise in Quality by Design
Impact We have generated some data and this is going towards an article to be published with other partners involved.
Start Year 2015
 
Description De Montfort University and University of Sunderland 
Organisation University of Sunderland
Country United Kingdom 
Sector Academic/University 
PI Contribution Development and application of advanced EHDA Technology
Collaborator Contribution Utilisation of rival technology for comparison (e.g. spray drying)
Impact There is an expectation to publish one research article from the data which is currently being generated
Start Year 2016
 
Description De Montfort University and University of Sussex 
Organisation University of Sussex
Department School of Biological Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Expertise in EHDA Technology
Collaborator Contribution Expertise in Spray Drying Technology
Impact We are exploring some initiatives at this stage with some exchange of information for a grant bid
Start Year 2017
 
Description De Montfort University and Zhejiang University 
Organisation Zhejiang University
Country China 
Sector Academic/University 
PI Contribution Expertise in EHDA with a focus on Pharmaceutical Engineering
Collaborator Contribution Expertise in EHDA with a focus on mechanical propsects
Impact Data has been generated through inkind support and collaborative research. There is an expectation to publish two articles.There is also a view to apply for funding where both partners can benefit.
Start Year 2016
 
Description De Montfort University and the University of Portsmouth 
Organisation University of Portsmouth
Department School of Earth & Environmental Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of emerging EHDA Techniques and Optimisation
Collaborator Contribution Biological assessment with some clinical aspects
Impact Data has been generated. There is an expectation to publish two papers.
Start Year 2015
 
Description 2nd International Confernece on Pharmaceutical Technologies, with emphasis on EHDA methods 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Integrated EHDA Technologies into the mainstream through comparison and evaluation. Demonstration of UK capability in EHDA and other technologies. Networking.
Year(s) Of Engagement Activity 2017
 
Description Academic-Industry experimental explorations 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Getting industrial involvement is crucial to take EHDA Technologies further. Academics are interacting with industries at network meetings and then also trying to establish common ground between technologies and industrial interests for further advances. Industries are also understanding EHDA technologies a lot more and the benefits these can bring to current medication and as other therapies. Industries have important specialisms and have realised there is good reason to take such developments further. Industries supporting the research with inkind support.
Year(s) Of Engagement Activity 2016,2017
 
Description Cross Institute Exploratory Research For Technology Enhancement 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Students (post-graduate) and/or academics undertake exploratory research based on network partner discussions. This includes visiting other laboratories on the network and also visiting some International research groups. There is also utilisation of technologies not accessible at their own location. Data generated will assist towards further work development and also possibly research manuscripts
Year(s) Of Engagement Activity 2015,2016,2017
 
Description EPSRC EHDA Network International Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact We organised this event and invited pioneers in the UK from several areas and also world-leading specialists who are Editors of top journals in the field and International prize winners. All those in the UK from students to established academics appreciated this. More importantly, very interesting discussions pursued with International speakers who were enlightened about the technology. Some of these speakers are seeking collaborative provision and have invited us to visit their laboratories- as expected.
Year(s) Of Engagement Activity 2016
 
Description Engagement of early career researchers (ECRs) in leading events 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Involving early career researchers (ECR's) at networking events taking key roles (opening sessions and leading discussions) has provided them with recognition amongst their peers and other senior academics on the network. This also provides ECRs a chance to develop their skills and engage with experts in the field
Year(s) Of Engagement Activity 2016,2017
 
Description Formal Sessio at the UK Premier Conference on Pharmaceutics- Dedicated session to EHDA Techologies. 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Invited to host a dedicated session on EHDA Technologies. Three talks by Network members. Integrated with Industry, academia and pharmacy practice. Explained the network and also the impact of the rapidly emerging technology.
Year(s) Of Engagement Activity 2017
 
Description International Networking and Collaborative Provision 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact While the network covers key players in the UK (and we have also engaged pioneers in related fields in the UK too); this activity provides an opportunity to work with internationally leading researchers in drug delivery, pharmaceutics and technologies. We have had a positive response to date and this will further market our network and hopefully extend its outputs and acceptance. Furthermore, these collaborative fronts provide potential publication, funding and technological enchantment opportunities.
Year(s) Of Engagement Activity 2016,2017
 
Description International dissemination 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Research around EHDA Technologies, sister (advanced merged) technologies and the efforts of the EHDA Network are being disseminated across UK, EU and Globally. This is being done through conferences, seminars and workshops. Conferences are wide reaching (pharmaceutical, materials, nanotechnologies, patient group driven, pharmacological) since our network has a broad coverage and expertise. We also have QbD (legislative), industrial and academic angles providing several points for contact. This provides collaborate provision through numerous themes. Network partners (and their students) are involved as we plan for long term impact for technological development, currently at the early stage
Year(s) Of Engagement Activity 2016,2017
 
Description Network Special Issue in AAPSPharmSciTech Journal entailing EHDA Technology and General Emerging Pharm Tech Structure Theme 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact A special issue was agreed by the Editor in Chief, Prof. Bill Williams, Texas and was part of the EPSRC EHDA Networks strategic plan.
The thematic issue is co-edited by Prof. Z Ahmad and Prof. M Edirisinghe and was based around Nano and Microstructures which essentially covers EHDA technologies but also brings other technologies into the fold, especially those already accepted and well known.
Ten articles have been published in the journal and the opening session acknowledges support. There is broad readership for the AAPSPharmSciTech Journal, which is part of the prestigious AAPS series. We also state that six articles have come from the EHDA Networks project partners which has increased our own capacity and outcomes. We also now begin to include EHDA Technologies in the same breath as existing technologies for researchers, industrialists and all others involved with emerging medicinal technologies.
Year(s) Of Engagement Activity 2016,2017
 
Description Portsmouth workshop for ECRs on Pharmaceutucal Technologies including EHDA 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Educating ECRS on technological advances in relation to Pharmaceutics. Greater understanding of process linkages and benefits for each type. Networking for ECRS and between Academics. Broadening Industry participation and understanding of EHDA and other emerging technologies etc.
Year(s) Of Engagement Activity 2017
 
Description Project Partner Meetings Between Multiple Specialists from Industry and Academia - Knowledge Advance and Technological Enhancement (including those from EU) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Detailed Discussions between Academics and Industrialists on pre-designed work packets bringing specific expertise to the research group. In addition this provided further discussion and off-shoots for exploratory research and collaborative provision. Industry engaged fully with EHDA techniques showing keen interest
Year(s) Of Engagement Activity 2015,2016,2017
 
Description Regular Steering Group Committee Meetings (De Montfort University) with the APS on Materials Science and Process Technologies and Manufacturing 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact We have managed to persuade two of the APS focus groups to accept the benefits and emergence of EHDA technologies. We continue to work with the APS focus groups and we are now part of regular discussion at the bi-monthly meetings. We look forward to moving forward .
Year(s) Of Engagement Activity 2015,2016,2017
 
Description Research and Technological Engagement with the Academy of Pharmaceutical Sciences UK -Recognition 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact The Academy of Pharmaceutical Sciences (APS) is the main organisation for Pharmaceutical Research in the UK. We have successfully persuaded them to include our efforts in EHDA to be represented alongside the well-established and emerging processes. We now have dedicated sessions at the APS and infact they were impressed to see the EHDA Network support part of the >15 posters at this event. They have also provided a provision for this on their web-pages for future events.
Year(s) Of Engagement Activity 2016,2017