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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
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.
PROGRAMME
09.30
10.00
Welcome
Dr Dave Elder, GSK
10.05
10.40
11.15
Refreshment break
11.35
12.10
12.40
14.00
14.35
15.10
Refreshment break
15.30
16.05
Close
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.
SPEAKERS
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.
DATE:
195 Members
295 Non-members
45 Students and Concessions
See JPAG website for more details
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