UCL Department of
Biochemical Engineering
enVISION
Issue 1 | Spring 2013
VISION at UCL provides an
opportunity for senior leaders in
the life science industries to do a
deep dive into the current and
pressing issues of this industry
Charles Cooney, MIT
INSIDE
Biopharmaceutical bioprocessing innovation
– a vision for the future P03
Does QbD make business sense? P04
Managing Manufacturing Economics P04
Briefings to date P06
Discover your future…today P07
Ready to Rock P07
Focus on…Core Course Back Page
1
enVISION WELCOME
UCL is ranked as one of the top ten world universities and
the leading London-based multi-faculty university. The
Department of Biochemical Engineering is acknowledged as
the UK Centre of Excellence in the field. We pride ourselves
in our ability to partner strategically with industry leaders to
create innovative programmes.
In collaboration with our leading partners from academia
and industry, we have developed VISION, a highly innovative
training programme for executives in the bio industries.
The VISION Programme is designed to develop long-lasting
relationships between academia and industry. Your business
can help define our ‘cutting-edge’ agenda and help to shape
our future direction.
This is a challenging time for global industry and through
partnership with us, we can give you the vision to help you
and your company succeed.
Benefits
Build networks and share knowledge through a world-class
open programme
Discuss leadership challenges and formulate actions needed
to address these challenges
Greatly enhance the agility of your organisation and how to
translate knowledge into commercial benefit
Access leading edge research that impacts the bottom line
Gain new perspectives on critical business issues
Regular E-bulletins keep you informed about latest
developments
Bioprocessing Matters newsletters
Annual Partners’ Dinner for networking
Costs
Briefings £50 each
Corporate membership £1,000-3,000 p/a
(dependent on company size)
Foreword
This is the first issue of enVision, a newsletter dedicated
to providing updates and information on new developments
in technical and business related matters of value to global
bioprocessing and biological sciences industries.
The VISION programme was launched in 2010 with the mission
statement “to be the nexus for the leaders of the biological sciences
and bioprocess industries to hear and debate the latest technological
and business developments in the sector.”
There is synergy between VISION and our departmental research
initiatives. VISION inspired outputs have led to research strategies
for the creation of new technologies as well as tools for business
decision making and Quality by Design implementation.
The programme consists of a core course held once a year
during Spring focused on leadership, innovation, and change
management. It is designed for the leaders and future movers
and shakers in our industry. In addition, the programme includes
a range of short, single subject focused briefings throughout the
year designed to address topical issues. These briefings are of
relevance not only to the professionals and practitioners in the
industry itself but also to those associated with them such as
financiers, lawyers, entrepreneurs and regulators – Our talks have
included: topics from challenges of Open Innovation, to Health
Economics, to the regulatory framework for biosimilars and for
commercialisation of stem cell research. We have hosted two
industrial showcases; one each for GE and Pall.
Starting VISION was not a light decision and was developed in
discussion with a specially set-up Advisory Board from industry
who felt the need for a dedicated forum where ideas can be
exchanged and new avenues explored. The inaugural Advisory
Board was headed by Dr Neil Weir - Senior Vice President of
Discovery at UCB and Chair of the ABPI Innovation Board –
with major input from all board members. I would like to thank
them for their encouragement and suggestions.
Benefits include places on the core course and at briefings,
recognition in printed materials and on the VISION website,
access to the department’s Industrial Training Open Day,
a direct connection to academic staff and students, the
opportunity to provide scholarships and awards and to
discuss collaborative opportunities.
We have had excellent feed-back from attendees.This has led us to
a new phase of sustained growth in our programme supported by
a new Strategy Advisory Board chaired by Dr Tony Bradshaw –
Co Director HealthTech & Medicines KTN – and board members
who have all agreed to help us through the next phase of
development.
Supporters
Eli Keshavarz-Moore
Professor of Bioprocess Science & Enterprise
(e.keshavarz-moore@ucl.ac.uk )
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enVISION news
Biopharmaceutical bioprocessing
innovation - a vision for the future
Dr. Tony Bradshaw
Chairman UCL VISION
Strategy Board
Director bioProcessUK-BIA
and Co Director Health KTN
It is essential that those with bioprocessing skills have more influence in their
organisations. VISION’s aim is to support the current and future generation of
bioprocessing leaders and ensure a better understanding of bioprocessing in
other corporate functions.
A UK perspective
VISION was established three years ago
building on UCL’s MBI® Training Programme.
MBI®, which has been established for nearly
twenty years, has trained 800 delegates in
300 organisations in technology areas such
as fermentation and downstream processing.
VISION builds on this training capability
and focuses on enabling bioprocessing
professionals to understand the business
drivers such as clinical trials, regulatory affairs
and business partnerships. Bioprocessing is
the set of technologies involved in translating
biopharmaceutical concepts into robust
processes and products.
The UK sector has a strong biopharmaceuticalbioprocessing base. Approximately fifty
UK companies own ten per cent of the
biopharmaceuticals in development worldwide
with a further 200 companies having Research,
Development or Manufacturing capabilities in
the UK. This is an emerging and sophisticated
high value manufacturing supply chain that
will reconvene at the 10th Annual bioProcessUK
Conference, which will be hosted by UCL in
December 2013.
Bioprocessing is a pivotal enabling technology
and business opportunity in its own right.
In order to drive success it is essential that
organisations have leaders with bioprocessing
knowledge to translate novel therapeutic
concepts into robust products and processes
for clinical trials and market. Many SMEs do
not have in house capability to make clinical
materials and rely on contract manufacturers
or partnerships with Big Pharma to realise their
Approximately fifty UK
companies own 10% of
the biopharmaceuticals in
development worldwide
goals. Bioprocessing professionals need to be
better equipped to maximise potential across
this supply chain.
UK Government and the industrial and
academic community have made considerable
progress. VISION has a big part to play here.
The establishment of the National Biologics
Industrial Innovation Centre, which will be a
hotbed of bioprocess technology development,
will compliment the UK’s outstanding academic
base. The academic base is vibrant and
well networked with industry as a result of
the Bioprocessing Research Industry Club,
which is funded by a combination of the
research councils and key UK companies. The
establishment of the Cell Therapy Catapult
provides further impetus in an area with
significant bioprocessing challenges. In addition,
the upgrading of UK fiscal incentives such as
lower corporation tax, introduction of the patent
box and improved R&D Tax credits provide a
major platform for investment in the UK. This
all creates an unrivalled opportunity for the UK
to be a global hub for high value manufacturing
of biopharmaceutical and cellular therapies. We
believe all these novel therapies can be touched
by UK design and manufacturing capability – just
like most Formula One racing cars are touched
by UK design and manufacturing expertise.
We have constructed a Strategy Board that
believes in the importance of bioprocessing for
business success, who are prepared to share
their insight into what is needed to capture
value for UK plc creating a major hub for global
biopharmaceutical and cellular therapy design
and manufacturing.
With such an ever increasingly vibrant
bioprocessing environment in the UK, the UCL
VISION course will develop the next generation
of bioprocessing leaders through a globally
recognised centre of bioprocessing excellence in
research and training at UCL.
VISION
Strategy Board
• Richard Alldread, Lonza
• Tony Bradshaw, Health KTN
(Chair)
• Crawford Brown, Eden
Biodesign
• Barry Buckland, BiologicB
• Andrew Davidson, Consultant
• Suzy Farid, UCL Biochemical
Engineering
• Richard Francis, Francis
Biopharma
• Gunter Jagschies, GE
• Peter Levison, PALL
• Jim Mills, Cantabio
• Tarit Mukhopadhyay, UCL
Biochemical Engineering
• Michelle Scott, Unicorn
Biologics
• Stuart Thompson, IP Group
• David Venables, NED Ark
Therapeutics
• Stephen Ward, Cell Therapy
Catapult
• Amanda Weiss, UCB
Links:
VISION course:
www.ucl.ac.uk/biochemeng/
industry/vision
BioProcessUK Conference:
www.bioprocessukannualconference.org
Cell Therapy Catapult:
https://catapult.innovateuk.org/
cell-therapy
UCL’s MBI® Training Programme:
www.ucl.ac.uk/biochemeng/
industry/mbi
EPSRC Centre link :
http://www.epsrc-cimmacromoleculartherapies.ac.uk
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enVISION news
Does QbD make
business sense?
An ironic response at a time when the regulatory agencies
seem to have taken QbD or more correctly the quality systems
represented in the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH) guidance Q8, Q9, Q10 and Q11. It seems
as if industry has yet to fully understand the potential value
proposition and potential in full implementation of QbD or the
ICH quality systems. When in reality this represents an open door
Managing
Manufacturing
Economics
UCL VISION Briefing: Biomanufacturing
Innovation Tools. Speeding from Concept to
Commerce.
Dr. Günter Jagschies,
Director Strategic Customer Relations
GE Healthcare Life Sciences,
Uppsala, Sweden
(Briefing delivered 15.5.12)
4
(Briefing delivered on 15.9.13)
to the intergration of good science within
industry quality systems.
As part of the value proposition for QbD key areas of focussed
utilisation above and beyond the traditional are reducing product
development cycle times, component of process control strategy
/ risk management, cost reductions, an essential tool for process
validation and continuous verification and a key component of
technology transfers.
Development & Manufacturing Costs
Regulatory agency expectations of product development are
an in depth understanding of both the process and product
characteristics. An approach often described as achieving this
is the principles of Quality by Design (QbD). QbD typically is
perceived as a labour intensive, costly program to deploy and
indeed it could be question does this approach made business
sense at all. For several years the regulatory agencies in particular
the FDA have discussed the concept of a desired state or new
era of drug quality the outcome of Pharmaceuticals for the 21st
century iniative. The FDA has a developed QbD road map and
planned implementation. Yet typically industry only really uses
QbD in the sense of small scale process models in a Design of
Experiments mode, supporting processes used for clinical and
not commercial supply. A barrier to the full implementation of a
QbD driven process development is the perceived costs and effort,
as represented in figure 1.
Richard Francis,
Founder,
Francis Biopharma Ltd
Increased Resources
(e.g. development costs,
organisational planning)
Current State
Cost / Time / Resources
Value Adding
Distraction or Benefit
Decreased Expenses
(e.g. manufacturing
costs, compliance costs)
• Empirical development approach
• Quality by testing & inspection
• Frozen process with reactive changes
DesiredState
• Quality by design development
• Flexible process & continual improvement
Initiate QbD Efforts
QbD Fully Realised
QbD Implementation Progress
Ref: MM Nasr, ISPE
National Meeting (2006)
Figure 1: Perception of cost and expenss in the migration from a
current non QbD state to a Desired QbD state.
In mathematical terms, there is nothing complicated about
economics as long as we are not asked to predict the future. It’s
all about adding or subtracting, multiplying or dividing, and about
percentage ratios. However, in real life we are asked to predict the
future as part of managing our finances. Most people in business,
apart from the highest levels of hierarchy, only get incomplete
information to perform their role in economics management and
are only looking at a more or less small piece of their company’s
finances. Via this compartmentalization of financial management,
small aspects regularly are turned into big and important, which
usually serves the purpose in particular of cost reductions in all
parts of a business well. However, when cost pressure is high
and gets priority, it also bears a significant risk of missing out
on the optimization of the overall spending where the biopharma
industry faces extremely complex relations between different
aspects and priorities. There are always choices to be made,
e.g., how to prioritize the use of limited R&D resources. As such
choices may have very far reaching impact and may in the worst
case severely limit the options in the future, the consequences
of short term cost gains can turn into truly expensive burden for
the company. This is not helped by the huge uncertainties about
enVISION news
Does QbD make business sense? continued
Intelligent based or science driven
manufacturing should be the key
goal of any drug developer.
These elements represent critical components of what is also
being termed “Intelligent Based Manufacturing” or knowledge
driven product lifecycle management. In a FDA sponsored
McKinsey report QbD is resulting in 25% reduction in process
development cycle times, 15 – 20% reductions in COG’s (mostly
my reduced process failure) and a 5% increase in productivity.
The claim is that if reproduced across the Parma industry
then the total savings would be $ 20 - $ 30 billion in savings.
(Source: CDER committee for Pharmaceutical Science and
Clinical Pharmacology – 27th July 2011). The cost of QbD
implementation typically is proving about 5% greater than
“traditional process development”. The Benefits can be 25%+
COG reduction, faster development times and greater assurance
of regulatory success. A significant return on Investment and
an assurance that the product will have a successful lifecycle.
Figure 2 shows the QbD driven continuous improvement process,
this supports intelligence based manufacturing which in turn
facilitates right first time batch manfacture and technology
transfers.
Intelligent based or science driven manufacturing should be the
key goal of any drug developer. Its not for the regulators benefits
but for the companies it future proofs the supply of product, it
Managing Manufacturing Economics continued
scientific and technical improvement or business related changes
in the future.
There are two rather well known cases in point describing
these risks for the biopharma industry: when ENBREL was first
introduced to the market demand grew so fast that production
capacity could not be ramped up quick enough and time was
lost to extend manufacturing to several additional sites. The fist
generation manufacturing process was simply not productive
enough to enable sufficient output from the original facility.
This delay caused a loss of revenue opportunity potentially in
the billions of dollars. The second case illustrates the opposite:
overcapacity. Genentech (and no one else either) could not
predict how successful attempts to improve the productivity of
cell culture processes would turn out and simply had to decide
at one point to build up manufacturing capacity in parallel to
the scientific efforts into cell based productivity. At the end both
efforts were (very) successful and shortly after Roche completed
its acquisition of Genentech, the announcement came that the
world’s largest, brand new facility for mammalian cell culture
Continuous Improvement
Risk Assessment to
prioritise further
investigation
Developed
Knowledge
CoE.
Process
Experience.
First Principles
Continuous
Improvement
Platform Process.
Scientific literature.
Process Space in
which Product
CQA’s are not
assured
Unknown
Knowledge
Design
HIGH RISK
Process Space in
which Product
CQA’s might be
assured
MEDIUM RISK
Operational
Continuous Process
Development
Risk reduction by
knowledge generation
Process Space in
which Product
CQA’s assured
LOW RISK
Figure 2: QbD driven continuous improvement
gives tools and a process for continual improvement. This means
that the company has the ability then to uses manufacturing
process efficiencies and Cost of Goods reductions as barriers to
challenges from competor or biosimilar products.
So the answer the question does QbD make business sense
is absolutely yes. So I do hope industry will start pushing the
boundaries of the design space of QbD and the ICH quality
systems to speed up the dawn of the era of true 21st century
Pharmaceutical Process Development.
products in Vacaville would be closed, a write-off of more than
$ 500 million of capital spent for a challenge that happened
differently than planned.
Flexibility and agility have become new buzzwords in an industry
with such challenge levels from uncertainty. Facilities that cost
a fraction of a legacy plant in this industry can be designed
with right sizing for current demand, fast adjustment to future
business, and multiple product flexibility. Modern technology
tools are productive to enable essentially any predicted market
demand to be manufactured and can be integrated with each
other to do so at cost levels at or below 30% of the legacy
processes in mammalian cell culture based businesses. Certain
dogma, such as the large scale of making clinical trial material
may need to be given up and new approaches such as continuous
processing may have to be welcomed in order to get to this
sweet spot of technical opportunity and business sense. What
is scientifically possible may not always make sense for the
business and 80 percent good may be good enough under
this angle of looking at a biopharmaceutical operation and the
management of its economics.
5
enVISION VISION BRIEFINGS
Briefings
to date
The VISION Briefings Series has had a
remarkable start with 14 briefings being held
to date (see opposite for a full listing).
We have attracted world-class experts in
a range of fields to give their analysis and
insights and predictions for the future.
What has surprised me is the ‘broad church’
from which delegates have come, ranging
from phama, biopharma, biotech, NHS,
charities, legal, regulators etc. This range of
organisations includes Biopharma Services,
Bird & Bird LLP, Cancer Research, GE
Healthcare, MHRA, PALL, Kings College
Hospital, UCB. This demonstrates the broad
relevance of the subject matter to many
sectors.
What has impressed me even more is the
insightful questioning of the topics under
discussion, the sharp debate and the friendly
networking that has followed. VISION is what
we intended, a hub where the latest business
and technological advances are explored and
their usefulness considered from many angles.
We have a wonderful programme planned
for this coming year covering topics such as
portfolio management and open innovation.*
I look forward to welcoming you to a Briefing
soon!
Dr Karen Smith
(karen.smith@ucl.ac.uk)
Director of Bioprocess
Leadership
*see back page for details
16/9/2010
De-risking Development
Prof Steve Arlington,
Partner leading the Global
Pharmaceutical Team
in Advisory Services,
PriceWaterhouseCoopers
13/1/2011
Biosimilars: A regulatory
perspective
Dr Mark Richardson,
Consultant, Richardson
Associates Regulatory Affairs
Ltd
Dr Marc Bisschops, Chief
Scientific Officer, Tarpon
Biosystems
6/12/2012
Technology challenges
to meet the expanding
vaccine boundaries
Prof Barry Buckland, CEO,
BioLogicB
10/3/2011
Disposable technology
– a technobusiness
perspective
29/1/2013
R&D costs of a new
medicine: what are the
key drivers?
Mrs Miriam Monge, VP
Marketing Biopharm Services.
Dr Jorge Mestre-Ferrandiz,
Director of Consulting, Office
of Health Economics
15/9/2011
Does QbD make
business sense? What
new approaches to
technology can make it a
viable proposition?
19/2/2013
Stem cell therapy clinical
trials – the rigours of EU
and UK regulation
Dr Mark Richardson PhD,
Consultant, FTOPRA
Richard Francis, Founder,
Francis Biopharma
19/1/2012
Does open innovation
work for the Biosciences
industries?
26/2/2013
A perspective on the
future of medical
provision
Vicki Salmon, Parnter, IP
Asset LLP & Michael Murray,
Managing Partner, IP Asset
Ventures.
Ray Hill, visiting Professor
of Pharmacology, Dept of
Medicine, Imperial College
London
15/5/2012
Managing manufacturing
economics
15/3/2012
Managing risk in the
bioprocesses – people
dynamics are often
overlooked?
Dr Gunter Jagschies, Senior
Director Strategic Customer
Relations, GE Healthcare Life
Sciences
13/9/2012
Process Knowledge
Management What
is it and is it Set
to Revolutionise
Bioprocessing?
Andrew Sinclair, Managing
Director, Biopharm Services
Ltd.
6
27/11/2012
Future of downstream
processing and the
role of continuous
chromatography
Roop Chandwani PhD, CEO,
Aggio Partners Limited
25/4/2013
The role of the Catapult
Centres (and the Centre
for Process Innovation
in particular) in
delivering innovation in
biotechnology
Dr Graham Hillier, Director
of Strategy and Technology,
CPI and the High Value
Manufacturing Catapult
enVISION events
Open Days:
If your organisation would be interested in
delivering a workshop jointly with us please contact
Dr Karen Smith at karen.smith@ucl.ac.uk
Discover your Ready to Rock
future…today!
The VISION programme has been
working with GE in a number of ways:
VISION-PALL DAY 5th March 2013
With speed-to-clinic and speed-to-market becoming increasingly
important, identifying and applying the right technical solutions
early in the development cycle can have a significant impact
on the efficacy of the drug development process. The Discover
Your Future…Today! was a one-day seminar offering a unique
chance to hear from regional opinion leaders in biotechnology
on key issues and find out how the latest technical innovations
can improve both the efficiency and quality of laboratory scale
processes.
Two excellent workshops (on Cell Culture and Purification and
Separation) were followed by a talk on ‘Formulation for improved
biopharmaceutical stability: considerations in early clinical
phases’ given by Dr Nick Darton, Platform Manager, Arecor
which was warmly received. This was then followed by a keynote
talk entitled ‘If new biologics are the answer to healthcare and
pharmaceutical industry challenges, what more might be done to
improve the timeline and success rate of getting those products to
market?’ given by Dr Tony Orchard, Pall Life Sciences.
• The siting of GE’s ‘Ready to Rock’ Truck on
Malet Place on the 25th May 2012 enabled VISION Core Course
delegates, members of the EPSRC Centre for Innovative
Manufacturing in Emergent Macromolecular Therapies and the
department’s EngD/PhD students and academic staff to see
in action the company’s Plug & Play biomanufacturing with
ReadyToProcess™ technologies.
• We also hosted a Microcarrier User Day on the 11th June
2012.This workshop, that made use of our Pilot Plant
facilities, provided selected postgraduates and industrialists an
opportunity to gain further insight into the use of microcarriers
for cell culture processes in single-use bioreactors. It
comprised of a series of presentations with case study
examples and a live demonstration of microcarrier preparation
for use with the WAVE™ bioreactor system.
There was a lively and informative Q&A session followed by a
drinks reception and a wonderful networking dinner sponsored by
PALL at Mele & Pere.
• Linked to the VISION core course, we are currently planning an
Upstream event with GE on the 21st May 2013.
7
enVISION events
Focus on…
Photos from
past events…
Liz Cullen,
Vision
Administrator
Core Course
22-24th May 2013
Leadership is about making things
happen, putting your stamp on
the future.
Our intensive Core Module has been designed to equip you
with the business related skills and knowledge you need. Over a
period of three days, sector-specific talks from thought leaders,
facilitated case studies and interactive problem-solving exercises
will enable you to enhance your capabilities.
Highlights include:
• Pathfinder: Executive Networking Workshop
• Theme 1: Changing Life Cycle and Alternative Business Models
• Theme 2: Leadership and Innovation
• Theme 3: Internal and External Risks and Supply Chain
A range of expert speakers drawn from
Europe and the US will include:
• Professor Steve Arlington, Partner, Head of Life Sciences
Practice, PriceWaterhouseCoopers
• Prof Barry Buckland , CEO of BiologicB
• Dr Gunter Jagschies, Senior Director Strategic Customer
Relations Leader, GE
• Dr Alain Pralong, Vice President New Product Introduction
and Industrialisation, GSK
• Dr Andrew Ramelmeier, Vice President of Manufacturing
& Facilities, BioMarin
• Vicki Salmon, Partner, IP Asset LLP
• Dr Michelle Scott, Partner, Unicorn Biologics
• Dr. Rahul Singhvi, President, Managing Partner Axella, LLC
After Dinner Talk
Industry – Academic Partnership:
A Boston Hub Enterprise Success Story
• Dr Suzy Farid, Reader, UCL Biochemical Engineering
• Dr Neil Weir, Senior Vice President of Discovery, UCB
Charles Cooney, Professor of Chemical and Biochemical
Engineering and Faculty Director of the Deshpande Center, M.I.T.
FREE EVENT FOR
CORE COURSE DELEGATES
8
Proposed VISION Briefing
Speakers for 2013–14:
• Jo Pisani, Partner, PriceWaterhouseCoopers
• Michelle Scott, Founding Partner, Unicorn Biologics
On the 21st May 2013, we are hosting a VISION-GE free event “European
Upstream Tour 2013”. Core Course delegates are welcome to participate.