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Biologics module

We were delighted to receive the news in April that we had secured BBSRC funding for the development of our new Biopharmaceuticals module through the Modular Training Partnership scheme.  This is a prestigious award for DMU and the award will enable us to significantly enhance our website platform as well as providing funding for promotional activities to support the module launch.  We are very grateful to Jamie Biddlecombe from Medimmune for supporting our application as a co-applicant and for the significant input Medimmune have already provided into the module development.  Plans for the module are well underway and we are working with collaborators across the US and Europe to put together an exciting series of lectures. Watch this space for news of our progress….!!

Industry Supporting Our MSc Projects

This has been a vibrant year with 12 MSc students and 10 Brazilian students doing their research projects in Pharmaceutical Quality by Design. We were pleased to have Thermo Fisher Scientific, BASF SE, Ashland and Merlin Powder Characterisation supporting five of the projects. The students were mentored by a team of industrial advisors, (Keith Purdy, Mark Gibson and Elaine Stone; former AstraZeneca) and DMU staff (Walkiria Schlindwein and Michael Goodman).

The focus of the projects was continuous processing. The students used a twin screw extruder (Pharma 11 HME, kindly loaned to us by Thermo Fisher Scientific) to develop wet granulation and hot melt formulations. They also compared continuous and batch processes for performing wet granulation. We would like to thank Thermo Fisher Scientific, BASF SE, Ashland and Merlin Powder Characterisation for their support.

Short Courses – Continuing Professional Development (CPD)

University funding via HEIF (Higher Education Innovation Fund) was secured in November 2013 to support the development of on-line short courses in QbD to target the continuing professional development (CPD) market. These short courses will provide inexpensive training to pharmaceutical scientists and other professionals who wish to engage in CPD but do not wish to pursue a formal qualification. The availability of training in ‘bite size’ modules also aligns well with initiatives by the Royal Pharmaceutical Society and the Academy of Pharmaceutical Sciences to establish competency based training structures for pharmaceutical scientists.

The short course will be a series of lectures of approximately 10-15 minutes in length to ensure the material is easily digestible and suitable for professionals in full time employment. The pilot short course Regulatory Guidelines, Principles and Tools of QbD is mid way through development and is expected to be available early next year.

E-learning platform upgrade

As part of the HEIF funding of the on-line short course development, we are working with an external provider (edatachase) to upgrade our website. This will drastically improve our user interface and enable the implementation of automated self-assessments etc. These will be a critical component of the on line short courses. In addition, data capture tools will be implemented enabling us to monitor our students’ progress. Administration of our mailing list, contact requests etc. will also be integrated within the new web platform. The new platform is due to be launched in March 2015.

Biologics Module

We are excited to be beginning work on a new Biologics module which we hope will be available sometime in 2014. We are busy establishing links with experts in the field and Walkiria recently attended a meeting in Cambridge ‘Streamlining Biopharmaceutical Development – Use of Design of Experiments’ which provided some useful contacts. We will also be attending the ‘Making QbD happen for biopharmaceuticals – the practice not the theory’ workshop in London in December. If you would like to get involved in this exciting development, please get in touch.

Science Industry Partnership

We are actively pursuing the opportunity to increase our involvement in work-based training through the initiatives being progressed as part of the government sponsored Science Industry partnership. The SIP is being led by GSK and co ordinated by Cogent. The proposed training pathways include an Industry Masters in Formulation Science (led by iFormulate) and also the Framework for Growth aimed at providing training to SMEs. We are in active discussions with Cogent, APS and iFormulate to explore ways in which our distance learning platform might support the various initiatives.

Learning Materials

Videos and slides for Module 3 are available to view below.

Lecture

1

Case study of in-process curing of EURADRAGIT NM30D (Thomas Dassinger, Evonik Industries, AG)

Lecture

2

Introduction to Inhalation Products (Andy Rignall, AstraZeneca)

Lecture

3

QbD for Inhalation Products I: Container/Closure & Supply Chain Considerations(Andy Rignall, AstraZeneca)

Lecture

4

QbD for Inhalation Products II: Biopharmaceutics & Product Characterisation Considerations (Andy Rignall, AstraZeneca)

Lecture

5

QbD for Inhalation Products III: Case Study (Andy Rignall, AstraZeneca)

Lecture

6

Practical application of QbD to freeze drying process development – Part 1 (Paul Matejtschuck, MHRA)

Lecture

7

Practical application of QbD to freeze drying process development – Part 2 (Paul Matejtschuck, MHRA)

Lecture

8

Applications of QbD in Lyophilisation (Matthew Brown, Lyosolutions)

Lecture

9

Analytical methods and QbD I: a synopsis of the traditional approach and its weaknesses (Pauline McGregor, PMcG Consulting)

Lecture

10

Analytical methods and QbD II: relating QbD to analytical methods (Pauline McGregor, PMcG Consulting)

Lecture

11

Analytical Methods and QbD III: applying QbD to analytical methods – Stage 1 – part 1 (Pauline McGregor, PMcG Consulting)

Lecture

12

Analytical Methods and QbD IV: applying QbD to analytical methods – Stage 1 – part 2 (Pauline McGregor, PMcG Consulting)

Lecture

13

Analytical Methods and QbD V: applying QbD to analytical methods – Stage 2 and 3 (Pauline McGregor, PMcG Consulting)

Lecture

14

QbD for Sterile Products (Tim Lukas, Pfizer)

Lecture

15

Risk Assessment & Defining Commercial Manufacturing Process (Rachel Brody, Pfizer)

Learning Materials

Videos and slides for Module 4 are available to view below.

Lecture

1

The regulatory aspects of QbD – inspection (Richard Funnell, MHRA)

Lecture

2

The regulatory aspects of QbD – writing a QbD submission (David Holt)

Lecture

3

QbD process engineering and process equipment in manufacturing (Trevor Page, GEA)

Lecture

4

Introduction to process controls/APCs (Keith Smith, Perceptive Engineering)

Lecture

5

Advanced Process Controls/APCs (Keith Smith, Perceptive Engineering)

Lecture

6

Introduction to continuous processing (Trevor Page, GEA)

Lecture

7

Continuous tablet manufacturing (Bindhu Gururajan, AstraZeneca)

Lecture

8

The tablet press as part of a continuous tableting line (Jurgen Boeckx, GEA)

Lecture

9

Real time release including Continuous Quality Verification (Penny Butterell, Pfizer)

Bite sized QbD study at DMU

Our distance learning course is highly flexible to enable you to study as little or as much as you would like to suit your individual needs. Individual modules can be studied in isolation without assessment, allowing you to fulfil your individual learning objectives and development needs.

Students wishing to gain a formal qualification will need to complete the required modules and assessments in order to gain University credits leading to a formal qualification (PG Cert, PG Dip or full MSc).

For a list of the latest available areas to study visit http://qbd.dmu.ac.uk/programmes-and-modules/

Don’t forget – delegates who attended our QbD symposium qualify for an exclusive 15% discount off the price of studying QbD, enrolling on the October 2013 intake