International Institute for Advanced Pharmaceutical Manufacturing (I2APM)

Lead Research Organisation: University of Strathclyde
Department Name: Inst of Pharmacy and Biomedical Sci

Abstract

The EPSRC Centre for Innovative Manufacturing for Continuous Manufacturing and Crystallisation is concerned with establishing new collaborations on the development of novel continuous manufacturing technologies to improve understanding of particle formation and to exploit this knowledge to enhance the manufacture of particles with specific beneficial properties. This has significant potential given the importance of particulate processing across many fine chemical industries including agrochemicals, pharmaceuticals, dyes, pigments and energetic materials.

In partnership with the US-based National Science Foundation Engineering Research Center for Structured Organic Particulate Systems, we propose to create the International Institute for Advanced Pharmaceutical Manufacturing with the goal of advancing the science and technology of integrated primary and secondary continuous manufacturing of pharmaceutical products. The aims of this project are to identify specific activities mapped onto the areas of mutual interest and start to agree forward exchanges, engage with industry and develop specific plans for joint meetings, researcher and faculty exchanges, collaborative research, and training activities that will benefit the wider community in both collaborating countries. In addition, the scope of a Mock Submission, the regulatory process by which new drugs are approved for use, will be developed by engaging jointly with UK/EU and US regulators and industry to agree on the framework that would ensure the impact of academic contributions on addressing the regulatory challenges for the adoption of continuous manufacturing.

The proposed links with international experts will lead to accelerated progress of integrating continuous manufacturing processes into the high value chemical sector, raise profile of UK-based research, and ultimately enhance the opportunities for high quality, collaborative research outcomes.

Planned Impact

The main beneficiaries from the research engagement proposed in this application will be the personnel in each of the respective Centres forming the International Institute. They will benefit from increased exposure and increased level of engagement with a view to driving forth their own research ideas as part of larger global mission to transform the current practises of pharmaceutical manufacture. Ultimately who will benefit from this Institute is the international pharmaceutical manufacturing sector and regulatory bodies. Therefore the beneficiaries will range from who is directly involved in the institute to those who are associated with the research outcomes.

Publications

10 25 50
 
Description Through the I2APM network, CMAC have worked with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create the following document: Draft Current Recommendations for Implementing and Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing. The document has been shared with industry, the public and the FDA
First Year Of Impact 2015
Sector Chemicals,Government, Democracy and Justice,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Policy & public services

 
Description International Institute of Advanced Pharmaceutical Manufacturing - Events Workstrand 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution As part of the I2APM Events workstrand, CMAC are working with C-SOPS and RCPE to organise an I2APM international symposium, which will be held at the Technology and Innovation Centre at the University of Strathclyde on 30th Nov 2016. The symposium will be an event open to CMAC, C-SOPS and RCPE where the staff and students from all three centres will come together to learn about research being carried out across all institutions.This will be done with oral, poster and networking sessions, as well as researcher sandpits to establish some areas of complementary collaboration and propose further researcher exchanges. In addition to the symposium, face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards
Collaborator Contribution C-SOPS and RCPE are working with CMAC to help organise the I2APM symposium
Impact Face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Events Workstrand 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution As part of the I2APM Events workstrand, CMAC are working with C-SOPS and RCPE to organise an I2APM international symposium, which will be held at the Technology and Innovation Centre at the University of Strathclyde on 30th Nov 2016. The symposium will be an event open to CMAC, C-SOPS and RCPE where the staff and students from all three centres will come together to learn about research being carried out across all institutions.This will be done with oral, poster and networking sessions, as well as researcher sandpits to establish some areas of complementary collaboration and propose further researcher exchanges. In addition to the symposium, face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards
Collaborator Contribution C-SOPS and RCPE are working with CMAC to help organise the I2APM symposium
Impact Face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Regulatory Workstrand 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution As part of the I2APM regulatory workstrand, CMAC are working with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create a Continuous Manufacturing Regulatory Guidance document. Input into this document from CMAC academics and industry partners was sent to C-SOPS in December 2015. This document was sent out by C-SOPS to industry for comment in Jan 2016, and will be sent out to public for comment in March 2016
Collaborator Contribution C-SOPS have initiated the creation of this document and are taking the lead on its circulation. RCPE are also inputting into this document in a similar manner to CMAC.
Impact Continuous Manufacturing Regulatory Guidance document has been drafted
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Regulatory Workstrand 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution As part of the I2APM regulatory workstrand, CMAC are working with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create a Continuous Manufacturing Regulatory Guidance document. Input into this document from CMAC academics and industry partners was sent to C-SOPS in December 2015. This document was sent out by C-SOPS to industry for comment in Jan 2016, and will be sent out to public for comment in March 2016
Collaborator Contribution C-SOPS have initiated the creation of this document and are taking the lead on its circulation. RCPE are also inputting into this document in a similar manner to CMAC.
Impact Continuous Manufacturing Regulatory Guidance document has been drafted
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Research Workstrand 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution As part of the I2APM research workstrand, a joint research project is underway between CMAC and Center for Structured Organic Particulate Systems (C-SOPS) in the US. The project aims to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. Batches of paracetamol of different particle sizes are being made at CMAC using continuous crystallisation and will be shipped to C-SOPS for secondary processing. Flowsheet models will be developed to produce batches of API with different variables eg size, agglomeration, and this research theme will investigate if changing these variables has an effect on the properties of the drug product tablets. In addition to this, researcher exchanges have been arranged between CMAC to C-SOPS, with a CMAC researcher visiting C-SOPS at Purdue for 2 months in March - April. Further exchanges are planned for later in 2016 and 2017
Collaborator Contribution C-SOPS will perform characterisation tests on the paracetamol batches mentioned above. They will then press batches of tablets and perform dissolution and physical testing, with an aim to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage.
Impact Research is currently ongoing
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Research Workstrand 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution As part of the I2APM research workstrand, a joint research project is underway between CMAC and Center for Structured Organic Particulate Systems (C-SOPS) in the US. The project aims to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. Batches of paracetamol of different particle sizes are being made at CMAC using continuous crystallisation and will be shipped to C-SOPS for secondary processing. Flowsheet models will be developed to produce batches of API with different variables eg size, agglomeration, and this research theme will investigate if changing these variables has an effect on the properties of the drug product tablets. In addition to this, researcher exchanges have been arranged between CMAC to C-SOPS, with a CMAC researcher visiting C-SOPS at Purdue for 2 months in March - April. Further exchanges are planned for later in 2016 and 2017
Collaborator Contribution C-SOPS will perform characterisation tests on the paracetamol batches mentioned above. They will then press batches of tablets and perform dissolution and physical testing, with an aim to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage.
Impact Research is currently ongoing
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Training Workstrand 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution As part of the I2APM training workgroup, CMAC are collaborating with Research Center Pharmaceutical Engineering (RCPE) in Austria and the Center for Structured Organic Particulate Systems (C-SOPS) in the US to collate training material from all 3 centres. The aim is to produce a training package of teaching material from CMAC, RCPE and C-SOPS, in different aspects of continuous manufacturing which can be offered to industry. Training material from CMAC, RCPE and C-SOPS has been collated and this material is currently being mapped onto different categories. Overlaps and gaps in training will be identified from this and going forward, training packages will be formulated. A training day will be held for CMAC researchers on 1st Dec 2016 to trial some of this training, and work is underway to plan for this.
Collaborator Contribution C-SOPS and RCPE are contributing as per the section above, by collating training material from each centre and formaulating training packages alongside CMAC
Impact A database of training has been collated with all training in continuous manufacturing which is offered by each of the 3 centres
Start Year 2015
 
Description International Institute of Advanced Pharmaceutical Manufacturing - Training Workstrand 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution As part of the I2APM training workgroup, CMAC are collaborating with Research Center Pharmaceutical Engineering (RCPE) in Austria and the Center for Structured Organic Particulate Systems (C-SOPS) in the US to collate training material from all 3 centres. The aim is to produce a training package of teaching material from CMAC, RCPE and C-SOPS, in different aspects of continuous manufacturing which can be offered to industry. Training material from CMAC, RCPE and C-SOPS has been collated and this material is currently being mapped onto different categories. Overlaps and gaps in training will be identified from this and going forward, training packages will be formulated. A training day will be held for CMAC researchers on 1st Dec 2016 to trial some of this training, and work is underway to plan for this.
Collaborator Contribution C-SOPS and RCPE are contributing as per the section above, by collating training material from each centre and formaulating training packages alongside CMAC
Impact A database of training has been collated with all training in continuous manufacturing which is offered by each of the 3 centres
Start Year 2015
 
Description Researcher placement - CMAC to C-SOPS 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution 2 x CMAC PhD. students visited C-SOPS (Rutgers) from 30th Sept - 28th Oct 2017
Collaborator Contribution Hosted CMAC researcher and added to knowledge base through training
Impact enhanced student experience and increase of knowledge base for department
Start Year 2017
 
Description Researcher placement - CMAC to C-SOPS 
Organisation Engineering Research Center for Structured Organic Particulate Systems (C-SOPS)
Country United States 
Sector Academic/University 
PI Contribution Researcher placement - CMAC researcher visited C-SOPS (Purdue) for 2 months in March - April 2016
Collaborator Contribution Hosted CMAC researcher and added to knowledge base through training
Impact enhanced student experience and increase of knowledge base for department
Start Year 2016
 
Description Researcher placement - CMAC to RCPE 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution CMAC PhD student visited RCPE in Graz for 2 months in Feb-March 2017
Collaborator Contribution Hosted CMAC researcher and added to knowledge base through training enhanced student experience and increase of knowledge base for department
Impact enhanced student experience and increase of knowledge base in the department
Start Year 2017
 
Description Researcher placement - CMAC to RCPE 
Organisation Research Center Pharmaceutical Engineering (RCPE) GmbH
Country Austria 
Sector Private 
PI Contribution CMAC PhD. visited (RCPE) in Graz from 28th July - 3rd Sept
Collaborator Contribution Hosted CMAC researcher and added to knowledge base through training
Impact enhanced student experience and increase of knowledge base for department
Start Year 2017
 
Description C-SOPS - I2APM Emerging Pharmaceutical Manufacturing Summit in Malta 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact The Emerging Pharmaceutical Manufacturing Summit was hosted by C-SOPS (Center for Structured Organic Particulate Systems) in conjunction with I2APM
The summit brought together first and second wave technology adopters and academics, along with a diverse group of regulators, to stimulate further dialogue and adoption of continuous manufacturing of pharmaceuticals.
Year(s) Of Engagement Activity 2017
 
Description I2APM International Symposium 
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 first I2APM International Symposium and Training Day, hosted by CMAC, took place in the Technology and Innovation Centre at the University of Strathclyde in Glasgow on 30th Nov-1st December 2016.
Researchers and academics from RCPE, C-SOPS and CMAC participated.
The event was opened in 30th November with talks from Prof Johannes Kinast (RCPE - centre director), Prof Alberto Cuitino (C-SOPS - research director), and CMAC Industrial Director Craig Johnston, who gave overviews of each centre, while CMAC Centre Manager Andrea Johnston provided an I2APM update.
The other delegates each presented a talk on their research and exhibited posters before participating in discussions and social activities with the goal of initiating new collaborations between the I2APM centres
Year(s) Of Engagement Activity 2016
URL https://www.i2apm.org/events.htm
 
Description I2APM International Training Day 
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 As part of the I2APM International Symposium, the I2APM training workgroup held a day of training on 1st December 2016 with sessions from C-SOPS, RCPE and CMAC.
Training sessions were given to academics and PhD students from CMAC, RCPE and C-SOPS on various aspects of continuous manufacturing from each of the 3 centres
Training sessions were a mixture of presentations, interactive sessions and group activity workshops
A researcher networking session was used to discuss collaborative research projects, and a total of 11 proposals for projects were obtained as a result.
Year(s) Of Engagement Activity 2016
URL https://www.i2apm.org/training.htm