want to be a strategic partner for our customers”
president, Bioprocess, Millipore India
first integrated validation and process development services lab,
popularly known as the Access Lab in Millipore India is shortly
completing five years of stellar service for pharma and biotech
manufacturers in India. During these five years, the scientists and
technologists in this lab have made a measurable difference to the
quality of consultancy available to the biopharma industry and has
helped manufacturers speed up their market entry initiatives. In an
exclusive interview with BioSpectrum Sudhir Kant (SK), president,
Millipore India and MS Mahadevan (MSM), vice president, Bioprocess,
Millipore India, share more insights.
When was the Access
Services Lab opened in India?
was inaugurated by our worldwide chairperson in December 2003. It was
approved in July 2004.
What was the thinking
behind opening the Access Services Lab in India?
Millipore always places the interests of customers before anything
else. Before our Access Lab came into being, Indian biopharma
manufacturers had to go to labs in the US and Europe for their
validation and process development needs. This causes months of delay
at a time when ‘speed to market’ was critical for
their success. The cost incurred was also high due to more expensive
services abroad. In addition customers faced tremendous difficulties in
coordinating and communicating with the labs abroad. Millipore
understood this pain point being faced by its customers and responded
with the world’s first integrated validation and PDS lab in
MSM: The result is that projects that used to take 6-9 months to
complete in labs abroad are now being done in Bangalore where our labs
deliver in 45 days to three months depending on the scope of the
What have been the
achievements of the Access Services Lab over the last five years?
Access Lab is the first one to deliver validation services for
pharmaceutical and biotechnology manufacturers and start a filter
validation lab in India. Through this lab we have worked with more than
30 top biopharmaceutical companies for filter validation and process
development services. We have developed downstream processes for more
than 10 biotech products and have trained more than 700 pharma and
biotech customers through ‘Back to School’ training
and paid certification programs.
What are the services
offered by the Access Services Lab in India?
Millipore has always been at the forefront of validation support,
process development and QA/QC. Millipore makes a measurable difference
with a full range of services spanning validation, process development,
process optimization, project management, microbiology, training and
consultancy. The studies conducted at Millipore include extractable,
bacterial retention, product integrity, filter compatibility and
preservative binding tests. In addition we develop and optimize
processes, we are good at aseptic processing and in
developing/optimizing processes for difficult to manufacture biologics
– particularly recombinant proteins and monoclonal
antibodies. In fact worldwide seven out of every 10 units of MAbs
manufactured involves partnering with Millipore.
Where else does
Millipore Corporation have comparable labs?
Other than India we have labs in Billerica (US), Molsheim (France) and
Yonezawa (Japan). There is no difference in terms of the quality of
infrastructure and expertise. We are more tuned to the specific needs
of Indian customers, the regulatory requirements of advanced highly
regulated markets (US and Europe) are being addressed by Indian
manufacturers. We offer regulatory support and validation services for
both biologics and pharmaceutical customers.
MSM: In addition to similar infrastructure, we have access to the same
database. This is critical for being sure about our data and results.
Our technologists are in regular touch with each other. Many of the
trainings are common with either faculty from abroad coming over or our
people being trained in the US and Europe. Work methods and protocols
are the same. Plus we benefit from the presence of Millipore experts
who consult constantly with regulators.
What has been the
growth of the Access Services Lab in India?
practice we do not share numbers. But we have been on target each year
for the last five years. The return on our initial investment was
recovered in the first nine months and our Compound Annual Growth Rate
(CAGR) has been impressive. Almost all the top 30 Indian manufacturers
have consulted with us and what is gratifying is that a high percentage
keep coming back to us with more projects.
In which areas have
you offered your solutions and services through the Access Lab?
Oncology, opthalmics, recombinant proteins, monoclonal antibodies,
anti-diabetics and sterile active pharmaceutical ingredients (APIs) are
some of the most popular therapeutic areas. There are of course many
other niche areas in addition.
What are the areas
that you feel will emerge in future?
Flexible bioprocessing solutions, mycoplasma, rapid microbiology are
the new areas. We are also looking at an incubation center. In a couple
of months we will organize an advanced training program to teach our
customers to manage people and processes together. Disposables will
become very popular in the coming years. The pace of acceptance is
going to grow fast.
What is the profile
of your technology group?
Millipore has more than 80 years of combined industry experience. We
have a dedicated team of experts who are either PhD holders or have a
master degree in microbiology, biochemistry, pharmacology or chemical
engineering. Millipore has always concentrated on education. We have
regularly been conducting training programs. In partnership with
Eppendorf and Metrohm we have also launched a mobile lab, we have
installed several equipments in it along with the literature. The lab
moves from college to college and educate students by giving them
Ch Srinivas Rao and