SPEAKERS:

DR JAMES DRINKWATER
Chairman of
Pharmaceutical and
Healthcare Sciences
Society
DAWN HILES
Newcastle Cellular
Therapies Facility
ANDREW HOPKINS
Expert GMDP Inspector,
MHRA
DR AILEEN HUME
AMRI
YAN HUNTER-BLAIR
NHS
DR PAUL NEWBY
GSK
DR TIM SANDLE
Bio Products Laboratory

Sterility assurance best practice for

aseptically manufactured products
Thursday 12th May 2016
Royal Society of Chemistry, London
The must-attend event for professionals engaged in pharmaceutical
sterility assurance:
Listen to highly focused, relevant content from experts & regulators
Learn the best practice and hear case studies not found elsewhere
Engage in powerful networking with top-level thought leading
speakers and professionals
Position yourself for a fast track to success
You will leave this event with:
Best practice and case studies from top opinion leaders, the MHRA,
industry and the NHS
New powerful connections you can use to propel yourself to success
An understanding of the latest state of the art equipment
Our sponsors:

Sterility assurance
best practice for aseptically manufactured products

Thursday 12th May 2016
Royal Society of Chemistry, London
Purpose of meeting
The purpose of the meeting is to deliver a best practice forum of like-minded
professionals engaged in the manufacture of aseptic pharmaceutical products.
JPAG have assembled a strong line up of opinion leaders and experts from the UK
regulator, the MHRA, industry and the NHS in the field of aseptic manufacture and
microbiological monitoring and testing to provide an excellent opportunity for
networking and bench marking for delegates. The meeting will also play host to
equipment providers to show the current state of the art in aseptic manufacturing
and testing equipment.
Challenge
The aseptic manufacturing community has the continuing challenge of maintaining
sterility assurance levels and meeting current regulatory expectations and
guidelines in order to protect the patient. Failure to comply results in severe
consequences and possibly the death of a patient.
Opportunities
As regulations evolve and new technologies develop, the pace of change varies in
the industry. Attendance at this meeting will offer delegates the opportunity of
learning from opinion leaders, regulators and delegates implementing best practice
in the challenge of production of aseptic medicinal products.
Proposed outcomes
Sharing of best practice, bringing delegates up to date with current regulatory
expectations and glimpsing state of the art equipment and a great opportunity to
network and share experiences with like-minded individuals engaged in the
manufacture and testing of aseptically manufactured medicinal products.

Registration commences at 09.30h and the symposium starts at 10.00h.

Book your seat today at:

www.jpag.org/cd75

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Joint Pharmaceutical Analysis Group

@JPAGgroup
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PROGRAMME

09.30

Registration and coffee

10.00

Welcome
Dr Dave Elder, GSK

10.05

Annex 1 requirements and common GMP deficiencies

Andrew Hopkins, Expert GMDP Inspector, MHRA

10.40

Isolator technology and validation of the gassing cycle

Yan Hunter Blair, Newcastle upon Tyne NHS Foundation Trust

11.15

Refreshment break

11.35

Sterility assurance challenges in the manufacture of advanced therapeutic

medicinal products
Dawn Hiles, Newcastle Cellular Therapies Facility, International Centre for Life

12.10

Maintaining microbiological control of clean rooms in an aseptic

manufacturing facility
Dr Aileen Hume, Manager, Microbiology, AMRI (Glasgow)

12.40

Lunch, Poster viewing * and Exhibition **

14.00

Risk-based environmental control and monitoring in aseptic processing

Dr James Drinkwater, Chairman of Pharmaceutical and Healthcare Sciences
Society

14.35

Best practice in the effective management of sterility test failures

Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory

15.10

Refreshment break

15.30

Use of rapid micro methods

Dr Paul Newby, GSK

16.05

Close

POSTERS AND EXHIBITION

There will be a display of approved posters that delegates will be able to view and
ask questions of the posters author.
If you wish to present your own poster, please see the information on this on the
JPAG website at www.jpag.org/info
* Approved Posters may be displayed. Abstracts for presentation as posters should
be sent to the Programme Co-ordinator, Paul Graham (paul@paulgrahamconsulting.com) by Friday 29 April, following the instructions on the JPAG website.
There will be an exhibition operating during tea and lunch breaks, where you will be
able to see the items on display and ask questions.
** Enquiries about exhibiting should be sent to events@jpag.org

SPEAKERS

Dr James Drinkwater - Pharmaceutical
and Healthcare Sciences Society
James Drinkwater is the Head of Aseptic processing technologies and GMP compliance at F Ziel Germany. In
addition James has a voluntary role as Chairman of the not for profit society: PHSS - Pharmaceutical and
Healthcare sciences society and leader of the PHSS Bio-contamination and RABS special interest groups. James is
an active member of the PDA and ISPE.
Having worked 10 years in the Pharmaceutical industry, Amersham UK now GE Healthcare this was followed by
positions of Technical Director at Barrier technology companies and Process and Compliance Director at a Biodecontamination company. James is a subject matter expert (SME) on Gaseous disinfection and surface
sterilisation using Hydrogen peroxide vapour (vH202) technologies together with associated biological indicators
with contribution to the PDA technical report 51 on BIs for gaseous decontamination processes.
James current specialisation is in the area Aseptic processing for sterile product manufacturing, filling and sterility
testing, working actively on projects providing support in process design, control strategies, risk based process
monitoring for solutions in contamination and cross contamination control together with GMP compliance.

Dawn Hiles - Newcastle Cellular Therapies Facility, International Centre for Life
Dawn Hiles is a HCPC registered Specialist Biomedical Scientist and Production Manager at Newcastle
Cellular Therapies Facility (NCTF), a facility which holds MHRA IMP and MS licences for the manufacture
of cellular advanced therapy medicinal products.
Dawn began working as a Biomedical Scientist at Newcastle upon Tyne NHS Hospitals specialising in
haematology and blood transfusion where she gained 11 years experience in the use of cellular and
blood derived products in wide range of clinical settings. In 2007 she completed an MSc in Biomedical
Science at Northumbria University and became a Fellow of the Institute of Biomedical Science. In 2011
she moved to Newcastle Cellular Therapies Facility as Senior Specialist Biomedical Scientist and worked
in the HTA regulated production of haematological stem cells for transplantation and the MHRA
regulated manufacture of cellular advanced therapy investigational medicinal products. Dawn has
worked on the aseptic manufacture of a range of somatic cell and tissue engineered products for
Phase I and II clinical trials in patients with hereditary and trauma induced vision impairment,
myocardial infarcts, stroke and arthritis.
Andrew Hopkins - Expert GMDP Inspector, MHRA
Andrew Hopkins has been with the MHRA since March 2005 as a GMDP Inspector. He has inspected in
areas including Sterile Pharmaceutical Manufacturing facilities, non Sterile Pharmaceutical
Manufacturing facilities and biotechnology and is responsible for ensuring that the Companies
inspected are compliant with EU GMP. He has also taken part in a number of discussion groups.
Andrew has been involved in a number of technological papers including the current version of the
PDA Technical Report No.1 and the UK PHSS papers for non-viable monitoring and Bio contamination
control strategies. He is currently the Chair person for the joint EMA and PIC/S working group regarding
the potential update to EU GMP Annex 1
Prior to joining the Agency Andrew worked in the Pharmaceutical industry for approximately 20 years
in positions including Quality Control, Quality Assurance and Production. He has a BSc(Hons) in
Microbiology with Genetics, a Post Graduate Diploma in Industrial Pharmaceutical Science and is also
a Member of the Institute of Biology.

SPEAKERS

Dr Aileen Hume - AMRI
Aileen Hume is Microbiology Manager at AMRI (Glasgow) Ltd. with over 10 years' experience of
working in Sterile Pharmaceutical Manufacturing facilities covering various positions in Microbiology.
Aileen started as Microbiology Scientist for Aptuit (Glasgow), focussing primarily on the WFI system, 'at
rest' monitoring of the clean rooms and Bioburden testing of bulk solution. Progressing to the Cancer
Research UK Formulation Unit in Strathclyde University sparked an interest in method suitability and
sterility testing. Time at Assured Micro Ltd. was spent consulting on environmental monitoring and
sampling plans for clients with cleaning regimes in a novel concept bringing together microbiological
expertise with the benefit of specialised cleaning from sister company Cleanroom Zone. A return to
AMRI (Glasgow) Ltd. (formerly Aptuit) sees a progressive improvement in cleanroom technology and a
continued focus on sterility assurance.
Aileen has a BSc (Hons) in Molecular Microbiology and a PhD in Life Sciences.
Prior to working in industry, research interests focussed on gene expression in yeast; including studying
virulence mechanisms in Candida, DNA Mismatch Repair mechanisms in Saccharomyces and using
Yarrowia as a model for ricinoleic acid pathways for possible biofuel production in plants.
Yan Hunter-Blair - Newcastle upon Tyne NHS Foundation Trust
Yan Hunter-Blair is Assistant Director of Pharmacy at The Newcastle upon Tyne Hospitals NHS
Foundation Trust. He is currently Head of Production for the Trust's Pharmacy Production unit Newcastle Specials which manufactures a range of non-sterile, terminally sterilised and aseptic
medicines under Specials and IMP licences for supply to the wider NHS. The unit also aseptically
prepares parenteral nutrition and chemotherapy for patients within the Trust's sites at Royal Victoria
Infirmary, Great North Children's Hospital, Freeman Hospital and Northern Centre for Cancer Care.
As a hospital pharmacist he specialised in pharmacy technical services, first working in aseptic
preparation, through radio-pharmacy before moving to an large hospital production unit which was
one of the first NHS units to use Vapour Hydrogen Peroxide VHP isolator technology. He is a member of
the NHS Pharmaceutical Production Committee and has an interest in supporting medicines for use in
clinical research.

Dr Paul Newby - GlaxoSmithKline

Paul Newby obtained both his BSc and PhD in microbiology from the University of Dundee. Following
his degrees, he undertook a Research Fellowship in food microbiology which is where his interest in
rapid microbiological methods started.
Paul has worked in the pharmaceutical industry in the area of non-sterile pharmaceutical microbiology
both in research and manufacture for the past 27 years. He has been actively involved in introducing
new technologies, project management, microbiological method development and validation.
Currently Paul manages the Pharmaceutical Development UK microbiology teams within GSK
Research & Development.
Paul is a member of the BP expert committee on microbiology where he has been actively involved in
reviewing the draft EP chapter on Rapid Methods. His is also part of the PDA technical working party
charged with updating Technical Report 33 'Evaluation, Validation and Implementation of New
Microbiological Testing Methods'.
Paul is part of the GSK Advanced Manufacturing Technology focus group. He advises on
microbiological aspects in developing an implementation strategy for GSK for a number of candidate
technologies. Previous successes include:
- The first PAT submission approval for Rapid method testing for non-sterile product testing
- Completion of a second Comparability protocol for water testing using rapid methods
- The first NDA and MAA approvals for non sterile product release using ATP bioluminescence
- Registration of a novel NIR based water activity method for non-sterile microbiological product
testing.

SPEAKERS

Dr Tim Sandle - Bio Products Laboratory

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical
processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The
University of Manchester School of Pharmacy. Tim is a committee member of the Pharmaceutical
Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific
journals. In addition, he has written over four hundred book chapters, peer reviewed papers and
technical articles relating to microbiology.

ABSTRACTS
Sterility assurance challenges in the manufacture of advanced therapeutic medicinal products
Dawn Hiles, Newcastle Cellular Therapies Facility, International Centre for Life
Advanced therapy medicinal products (ATMP) are a novel group of medicines including gene
therapy, somatic cell and tissue engineered products that have become notable for their potential to
treat a range of diseases that cannot be managed by conventional medicines. Hundreds of new cell
therapy products are under evaluation in clinical trials worldwide and a small number have attained
European marketing approval. Given the growth of the ATMP industry and obvious appeal to clinicians
and patients the number of these medicines entering hospitals and number of developers seeking
licenced facilities to manufacture their product is increasing year on year. While legislation dictates
that ATMPs must be manufactured the same way as any other sterile medicine there are a number of
challenges that require to be addressed. Viable cell and tissue based material cannot be terminally
sterilised, starting material may be of limited availability and/or quality and a batch of product is often
a single small volume unit with a short shelf life. During this presentation some of the technical and
logistical hurdles we have faced with sterility assurance while manufacturing ATMPs will be presented
here as case studies.

Maintaining microbiological control of clean rooms in an aseptic manufacturing facility

Dr Aileen Hume, Manager, Microbiology, AMRI (Glasgow) Ltd
Having spent approximately 14 months in my current role as Microbiology Manager at AMRI (Glasgow)
Ltd, it seems an appropriate time to reflect on the difficulties of maintaining microbiological control of
the clean rooms over the past year and the improvements made to address these findings; essentially
a year in the life of the clean rooms. Overcoming nature's problems of seasonal variation leading to
increased counts sampled from the water system, increased incidents of Gram negative species
during the winter and increased counts of environmental isolates, including spore-formers over the
summer months demonstrates that the underlying operator-derived Micrococcus and Staphylococcus
species are not the only threat to sterility assurance in the clean room. Not to mention the additional
challenge of identification of isolates that are simply too damaged/stressed by the harsh clean room
environment to grow when sub-cultured.
The greatest improvement to establishing/understanding the threat to sterility assurance within the
clean room has undoubtedly been the introduction of video cameras at key locations allowing an
overview of critical activities. In-line with continuous particulate data, footage has been used to assess
clean room conduct, operator technique and assess sterility assurance in association with
environmental monitoring. This has effectively reduced the time spent on investigations by helping
determine root cause; allowing the microbiologists to focus on genuine excursions and OOS results.
Problems associated with shutdown are discussed, including Risk Assessment for Environmental
Monitoring locations following major change. In addition, through demonstration of case study, we see
that not all improvements have the desired effect and can even impact the cleanroom environment
in a number of ways.

Sterility assurance best practice for aseptically

manufactured products

DATE:

Thursday 12th May 2016

VENUE: Royal Society of Chemistry,

Burlington House, Piccadilly,
London W1J 0BA
FEES:

195 Members
295 Non-members
45 Students and Concessions
See JPAG website for more details

Map Google

TRAVEL: The RSC is very conveniently

located in central London, with
Piccadilly Circus and Green Park
Underground stations just a few
minutes' walk away. The nearest
train stations are Charing Cross (10
minutes' walk), Waterloo, Victoria
and Kings Cross/St Pancras (10
minutes by taxi).
ACCOMMODATION:
See JPAG website for details

The RSC at Burlington House, Piccadilly

OTHER: For other details, see JPAG website

at www.jpag.org/info

Book your seat today at www.jpag.org/cd75

Sterility assurance best practice for aseptically

manufactured products
Thursday 12th May 2016
Royal Society of Chemistry. London

Book your seat today at www.jpag.org/cd75