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22 BioProcess International APRIL 2007
Biotechnology in Malaysia
by Scott M. Wheelwright
M
alaysia has a thriving
biotechnology industry that
combines a strong emphasis
on botanical derivatives
with a solid education tradition
established during colonial times. The
country has more than 65 life science
and biotechnology companies that are
supported by 14 academic institutions
and another 24 research institutes (1).
More than 50 government ministries
and organizations are involved in
Malaysian life science activities.
A BRIEF HISTORY
Although ancient human inhabitants
occupied parts of Malaysia tens of
thousands of years ago, its recorded
history begins with early Hindu
kingdoms that thrived from 2,000 to
600 years ago (2). The development of
cities and trading centers resulted
from favorable conditions for sea
travel and natural harbors that
provided shelter and opportunities for
growth through international trade.
The port city of Malacca, south of the
current capital of Kuala Lumpur, rose
to prominence in the early 1400s as
Islamic traders brought a new culture
that flourished.
European traders, seeking a route
to the fabled spice islands (now part of
eastern Indonesia) in the early 1500s,
established colonies in Malaysia to
support their trade. The Dutch built a
massive fort at Malacca, and the
English maintained a fortified trading
center on Penang Island near what is
now the Thai border. Later the British
solidified their hold on the peninsula
and ran extensive tin mining
operations, ultimately establishing
Singapore at the southern tip.
Malaysia gained independence from
Britain in 1957.
One legacy of Malaysia’s colonial
period is a strong English-language–
based education system. Most
university graduates in the country
speak very good English and have
broad scholastic achievements. They
are a well-educated work force with a
good grasp of international business as
well as technical and scientific
fundamentals. The current
government of Malaysia has a solid
infrastructure of laws and civil rights
the protect the freedoms and
opportunities of its citizens.
BIOTECHNOLOGY TODAY
As is the case throughout Asia,
Malaysia has a history of
biotechnology processing for food and
beverages including production of
yogurt, soy sauce, and traditional
foods as well as rice grain for
fermented beverages (3, 4, 5). However,
the use of deep-tank liquid
fermentations has become common
only in recent decades, as has occurred
throughout most of the world.
Government Support: As
recognized by Prime Minister
Abdullah Bin Ahmad Badawi in his
message to participants in
BioMalaysia 2006, “Commercial
biotechnology and life sciences is still
in the initial stage of development in
Malaysia” (6). Several government
initiatives are under way to promote
biotechnology in this country. The
The InnoBio facility for contract manufacturing near Kuala Lumpur.
PHOTO BY SCOTT M. WHEELWRIGHT
Reprinted with permission from BioProcess International 5(4):22-25 (April 2007)
24 BioProcess International APRIL 2007
government has established the
Malaysian Biotechnology Corporation
(BiotechCorp) to promote
development of local biotechnology
(9). The objective of BiotechCorp is
“to identify value propositions in both
R&D and commerce and support
these ventures via financial assistance
and developmental services.”
BiotechCorp is owned by the Ministry
of Finance and is led by a
government-appointed council under
the Ministry of Science, Technology,
and Innovation. Key mandates include
“the nurture and growth of biotech
companies in Malaysia, create a
conducive environment for
biotechnology, and actively promote
foreign direct investments in
biotechnology.”
One way BiotechCorp is executing
its mandate is through the BioNexus
initiative, which has as one of its
objectives creation of a network of
biotech companies and organizations
that build on the existing
infrastructure of universities and
research institutes throughout the
country. Another goal of the
BioNexus program is to create centers
of excellence that focus on particular
areas of research and development.
Already, three such centers have been
established: the Institute of
Agricultural Biotechnology, the
Malaysian Genome Institute, and the
National Pharmaceutical and
Nutraceutical Institute. The first two
are located in Selangor, near Kuala
Lumpur, and the third is located at
the Science University of Malaysia,
which is in Penang to the northwest
of Kuala Lumpur.
The BioNexus initiative allows the
Malaysian government to confer
BioNexus status on selected
companies (both local and foreign),
providing benefits including eligibility
for financial incentives and assistance,
access to shared equipment and
facilities, and administrative support
through BiotechCorp. Substantial tax
incentives are available to companies
qualifying for BioNexus status.
Academic and Research Institutes:
Several major industries in Malaysia
are built around agricultural products
including palm oil, natural rubber,
timber, and rice. The country is also
known for its electronics fabrication
and assembly plants. Economic ties to
agriculture have resulted in much of
the life science research also focusing
on it. In addition to support for local
industry, Malaysia has strong life
science research programs in
nutraceuticals and botanical extracts,
many of which are exported to the
United States and Europe.
Several universities have strong
teaching and research programs in the
fundamental life sciences and in
engineering. Graduates of these
programs are well trained in the
science and techniques required for
successful work in biotechnology
research and development laboratories.
Private Enterprise: Of the more
than 65 companies listed in the
BiotechCorp directory, two-thirds are
engaged in healthcare and related
technologies including sophisticated
areas such as bioinformatics. The
remaining one-third of companies are
focused on agriculture.
Development of bioinformatics in
Malaysia is an outgrowth of a strong
national infrastructure supporting
communications technology.
Successful entrepreneurs in
information technology related to
electronics have brought their skills to
bear on challenges faced by life
science researchers, including
intelligent data analysis, pattern
relationship recognition, and project
management solutions for clinical
development programs.
Several companies are developing
novel pharmaceutical products. One of
these, Bioven, has established
relationships with multiple institutes
in Cuba and is actively developing
products from those Cuban partners
for approval and distribution in
Malaysia and elsewhere. Another,
Duopharma, manufactures more than
300 items for use in Malaysia and for
export, including small-volume
injectables and generic
pharmaceuticals. GENERTI
Biosystems fabricates molecular
diagnostics and is focused on blood
disorders. Additionally, two
companies have recently been
The country of Malaysia is located in southeast Asia, divided roughly in half between the
Malay Peninsula south of Thailand and the northwest part of the island of Borneo, which it
shares with Indonesia. The coastline of Malaysia is about double that of California; however,
the total land area is slightly smaller than California’s (4, 7). At 26 million (as of 2005),
Malaysia’s population is about three quarters of California’s, and it is expected to grow to 32
million over the next 10 years (8). UNITED STATES CENTRAL INTELLIGENCE AGENCY (WWW.CIA.GOV).
The 88-story Petronas Towers of Kuala
Lumpur. PHOTO BY SCOTT WHEELWRIGHT.
APRIL 2007 BioProcess International 25
established to provide contract
manufacturing services to the global
biopharmaceutical industry. Alpha
Biologics and Inno Biologics are
preparing to open their doors to
clients in the near future.
Inno Biologics (also referred to as
InnoBio) is under the direction of
Mohd Nazlee Kamal, who has over 20
years experience in the biotechnology
industry and holds a PhD in chemical
engineering from the University of
Queensland in Brisbane, Australia.
The InnoBio facility contains
60,000 ft2 of laboratories, offices, and
manufacturing space. The GMP
production areas, which total 6,000 ft2,
were built as modules in Germany,
where they were fully assembled and
inspected by local regulatory
authorities, transported to a site in
Malaysia just south of Kuala Lumpur,
and reassembled as an integrated
facility. InnoBio provides animal cell
culture services that include genetic
constructs, host and cell line
development, process development and
scale-up, analytical methods
development and validation, and
CGMP manufacturing of bulk drug
substances for use in clinical trials. The
company’s largest bioreactor has a
volume of 1,000 L.
Alpha Biologics is under the
direction of Simon Saxby, who has
over 25 years experience in the
biotechnology industry including the
design, construction, and operation of
CGMP-compliant contract
manufacturing facilities. This
company is located on the island of
Penang to the northwest of Kuala
Lumpur. Alpha Biologics provides
animal cell culture services that
include cell line development, process
and analytical methods development,
and CGMP manufacturing of bulk
drug substances for use in clinical
trials in their 50,000-ft2 facility. The
company also has a development
center in Cambridge in the United
Kingdom.
MALAYSIA’S BIOTECH FUTURE
Malaysia has a solid education
infrastructure with academic and
government support driving a small
but growing biotechnology industry.
Private enterprises are building on the
local industrial capabilities in
information technology,
communications, and agriculture to
develop life science products for the
local and for global markets. The
establishment of contract
manufacturing companies that provide
process development and CGMP
production for biopharmaceuticals will
increase attention on the region.
REFERENCES
1 Biotechcorp Directory. Malaysian
Biotechnology Corporation: Kuala Lumpur,
Malaysia, 2006.
2 Malaysian Timeline. interKnowledge
Corp., 2006; www.geographia.com/Malaysia/
timeline.htm.
3 Arujanan M. Biotechnology In Malaysia.
Malaysian Biotechnology Information Center:
Monash University Malaysia, Selangor,
Malaysia, 2007; www.bic.org.my/
?action=localscenario&do=biotechnology.
4 United Nations Development Program
Malaysia, 2007; www.undp.org.my/index.
php?navi_id=27.
5 Fermented Cereals: A Global Perspective.
Food and Agricultural Organization of the
United Nations: Rome, Italy, 1999; www.fao.
org/docrep/x2184e/x2184e09.htm.
6 Y.A.B. Dato’ Seri Abdullah Haji
Ahmad Badawi, Prime Minister of Malaysia.
Message: BioMalaysia 2006 Conference and
Exhibition, December 2006, Kuala Lampur.
7 California Facts and Figures. The
Columbia Electronic Encyclopedia, 6th Edition.
Lagasse P, Ed. Columbia University Press:
New York, NY, 2007. www.infoplease.com/
ce6/us/A0857124.html.
8 California Quick Facts from the US
Census Bureau, 2007; http://quickfacts.census.
gov/qfd/states/06000.html.
9 Malaysian Biotechnology Corporation,
2007; www.biotechcorp.com.my. 
Scott M. Wheelwright, PhD, is president
of Strategic Manufacturing Worldwide, Inc.,
13119 Glen Brae Drive, Saratoga, CA 95070,
1-408-420-5352, info@smwbiotech.com.
Artist rendering of Alpha Biologics facility
in Penang. COURTESY OF ALPHA BIOLOGICS.
SMW Overview »
SMW provides consulting services to biotechnology companies,and related industries,in the areas of
process development and manufacturing. From R&D to Phase 3 to distribution,SMW is uniquely quali-
fied to help commercialize your products. We provide technical expertise, with the discipline of
project management, to help speed critical therapies to market.
SMW Services »
Process Development
• Strategy and planning
• Design
• Assay method development
• Technology transfer
• Scale-up
• Optimization
• Transfer to manufacturing
Manufacturing – pilot through commercial
• Strategy and planning
• Resource allocation
• Compliance with cGMP
• Risk analysis and reduction
• Chemistry, Manufacturing and Controls
document preparation
• Technology transfer
• Facility Construction
SMW Strengths »
• Over 20 years corporate experience
• Expertise in the areas of yeast and bacteria fermentation,
monoclonal antibodies, proteins, and viruses
• Background in oncology, infectious disease, cardiovascular,
wound healing, angiogenesis, and vaccine products
• Specialty focus in facilitating outsourcing
• International expertise: United States, Asia, Japan and Europe
• Global experience with regulatory bodies, including FDA,
EU/EMEA, MHLW and WHO
• Fluency in Japanese and English
We work with companies of all sizes and budgets.
Please contact us for more information:
Scott M.Wheelwright,Ph.D.
info@smwbiotech.com
408.420.5352
www.smwbiotech.com
StrategicManufacturingWorldwide,Inc.
Bringing Products to Market

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Biotechnology In Malaysia

  • 1. 22 BioProcess International APRIL 2007 Biotechnology in Malaysia by Scott M. Wheelwright M alaysia has a thriving biotechnology industry that combines a strong emphasis on botanical derivatives with a solid education tradition established during colonial times. The country has more than 65 life science and biotechnology companies that are supported by 14 academic institutions and another 24 research institutes (1). More than 50 government ministries and organizations are involved in Malaysian life science activities. A BRIEF HISTORY Although ancient human inhabitants occupied parts of Malaysia tens of thousands of years ago, its recorded history begins with early Hindu kingdoms that thrived from 2,000 to 600 years ago (2). The development of cities and trading centers resulted from favorable conditions for sea travel and natural harbors that provided shelter and opportunities for growth through international trade. The port city of Malacca, south of the current capital of Kuala Lumpur, rose to prominence in the early 1400s as Islamic traders brought a new culture that flourished. European traders, seeking a route to the fabled spice islands (now part of eastern Indonesia) in the early 1500s, established colonies in Malaysia to support their trade. The Dutch built a massive fort at Malacca, and the English maintained a fortified trading center on Penang Island near what is now the Thai border. Later the British solidified their hold on the peninsula and ran extensive tin mining operations, ultimately establishing Singapore at the southern tip. Malaysia gained independence from Britain in 1957. One legacy of Malaysia’s colonial period is a strong English-language– based education system. Most university graduates in the country speak very good English and have broad scholastic achievements. They are a well-educated work force with a good grasp of international business as well as technical and scientific fundamentals. The current government of Malaysia has a solid infrastructure of laws and civil rights the protect the freedoms and opportunities of its citizens. BIOTECHNOLOGY TODAY As is the case throughout Asia, Malaysia has a history of biotechnology processing for food and beverages including production of yogurt, soy sauce, and traditional foods as well as rice grain for fermented beverages (3, 4, 5). However, the use of deep-tank liquid fermentations has become common only in recent decades, as has occurred throughout most of the world. Government Support: As recognized by Prime Minister Abdullah Bin Ahmad Badawi in his message to participants in BioMalaysia 2006, “Commercial biotechnology and life sciences is still in the initial stage of development in Malaysia” (6). Several government initiatives are under way to promote biotechnology in this country. The The InnoBio facility for contract manufacturing near Kuala Lumpur. PHOTO BY SCOTT M. WHEELWRIGHT Reprinted with permission from BioProcess International 5(4):22-25 (April 2007)
  • 2. 24 BioProcess International APRIL 2007 government has established the Malaysian Biotechnology Corporation (BiotechCorp) to promote development of local biotechnology (9). The objective of BiotechCorp is “to identify value propositions in both R&D and commerce and support these ventures via financial assistance and developmental services.” BiotechCorp is owned by the Ministry of Finance and is led by a government-appointed council under the Ministry of Science, Technology, and Innovation. Key mandates include “the nurture and growth of biotech companies in Malaysia, create a conducive environment for biotechnology, and actively promote foreign direct investments in biotechnology.” One way BiotechCorp is executing its mandate is through the BioNexus initiative, which has as one of its objectives creation of a network of biotech companies and organizations that build on the existing infrastructure of universities and research institutes throughout the country. Another goal of the BioNexus program is to create centers of excellence that focus on particular areas of research and development. Already, three such centers have been established: the Institute of Agricultural Biotechnology, the Malaysian Genome Institute, and the National Pharmaceutical and Nutraceutical Institute. The first two are located in Selangor, near Kuala Lumpur, and the third is located at the Science University of Malaysia, which is in Penang to the northwest of Kuala Lumpur. The BioNexus initiative allows the Malaysian government to confer BioNexus status on selected companies (both local and foreign), providing benefits including eligibility for financial incentives and assistance, access to shared equipment and facilities, and administrative support through BiotechCorp. Substantial tax incentives are available to companies qualifying for BioNexus status. Academic and Research Institutes: Several major industries in Malaysia are built around agricultural products including palm oil, natural rubber, timber, and rice. The country is also known for its electronics fabrication and assembly plants. Economic ties to agriculture have resulted in much of the life science research also focusing on it. In addition to support for local industry, Malaysia has strong life science research programs in nutraceuticals and botanical extracts, many of which are exported to the United States and Europe. Several universities have strong teaching and research programs in the fundamental life sciences and in engineering. Graduates of these programs are well trained in the science and techniques required for successful work in biotechnology research and development laboratories. Private Enterprise: Of the more than 65 companies listed in the BiotechCorp directory, two-thirds are engaged in healthcare and related technologies including sophisticated areas such as bioinformatics. The remaining one-third of companies are focused on agriculture. Development of bioinformatics in Malaysia is an outgrowth of a strong national infrastructure supporting communications technology. Successful entrepreneurs in information technology related to electronics have brought their skills to bear on challenges faced by life science researchers, including intelligent data analysis, pattern relationship recognition, and project management solutions for clinical development programs. Several companies are developing novel pharmaceutical products. One of these, Bioven, has established relationships with multiple institutes in Cuba and is actively developing products from those Cuban partners for approval and distribution in Malaysia and elsewhere. Another, Duopharma, manufactures more than 300 items for use in Malaysia and for export, including small-volume injectables and generic pharmaceuticals. GENERTI Biosystems fabricates molecular diagnostics and is focused on blood disorders. Additionally, two companies have recently been The country of Malaysia is located in southeast Asia, divided roughly in half between the Malay Peninsula south of Thailand and the northwest part of the island of Borneo, which it shares with Indonesia. The coastline of Malaysia is about double that of California; however, the total land area is slightly smaller than California’s (4, 7). At 26 million (as of 2005), Malaysia’s population is about three quarters of California’s, and it is expected to grow to 32 million over the next 10 years (8). UNITED STATES CENTRAL INTELLIGENCE AGENCY (WWW.CIA.GOV). The 88-story Petronas Towers of Kuala Lumpur. PHOTO BY SCOTT WHEELWRIGHT.
  • 3. APRIL 2007 BioProcess International 25 established to provide contract manufacturing services to the global biopharmaceutical industry. Alpha Biologics and Inno Biologics are preparing to open their doors to clients in the near future. Inno Biologics (also referred to as InnoBio) is under the direction of Mohd Nazlee Kamal, who has over 20 years experience in the biotechnology industry and holds a PhD in chemical engineering from the University of Queensland in Brisbane, Australia. The InnoBio facility contains 60,000 ft2 of laboratories, offices, and manufacturing space. The GMP production areas, which total 6,000 ft2, were built as modules in Germany, where they were fully assembled and inspected by local regulatory authorities, transported to a site in Malaysia just south of Kuala Lumpur, and reassembled as an integrated facility. InnoBio provides animal cell culture services that include genetic constructs, host and cell line development, process development and scale-up, analytical methods development and validation, and CGMP manufacturing of bulk drug substances for use in clinical trials. The company’s largest bioreactor has a volume of 1,000 L. Alpha Biologics is under the direction of Simon Saxby, who has over 25 years experience in the biotechnology industry including the design, construction, and operation of CGMP-compliant contract manufacturing facilities. This company is located on the island of Penang to the northwest of Kuala Lumpur. Alpha Biologics provides animal cell culture services that include cell line development, process and analytical methods development, and CGMP manufacturing of bulk drug substances for use in clinical trials in their 50,000-ft2 facility. The company also has a development center in Cambridge in the United Kingdom. MALAYSIA’S BIOTECH FUTURE Malaysia has a solid education infrastructure with academic and government support driving a small but growing biotechnology industry. Private enterprises are building on the local industrial capabilities in information technology, communications, and agriculture to develop life science products for the local and for global markets. The establishment of contract manufacturing companies that provide process development and CGMP production for biopharmaceuticals will increase attention on the region. REFERENCES 1 Biotechcorp Directory. Malaysian Biotechnology Corporation: Kuala Lumpur, Malaysia, 2006. 2 Malaysian Timeline. interKnowledge Corp., 2006; www.geographia.com/Malaysia/ timeline.htm. 3 Arujanan M. Biotechnology In Malaysia. Malaysian Biotechnology Information Center: Monash University Malaysia, Selangor, Malaysia, 2007; www.bic.org.my/ ?action=localscenario&do=biotechnology. 4 United Nations Development Program Malaysia, 2007; www.undp.org.my/index. php?navi_id=27. 5 Fermented Cereals: A Global Perspective. Food and Agricultural Organization of the United Nations: Rome, Italy, 1999; www.fao. org/docrep/x2184e/x2184e09.htm. 6 Y.A.B. Dato’ Seri Abdullah Haji Ahmad Badawi, Prime Minister of Malaysia. Message: BioMalaysia 2006 Conference and Exhibition, December 2006, Kuala Lampur. 7 California Facts and Figures. The Columbia Electronic Encyclopedia, 6th Edition. Lagasse P, Ed. Columbia University Press: New York, NY, 2007. www.infoplease.com/ ce6/us/A0857124.html. 8 California Quick Facts from the US Census Bureau, 2007; http://quickfacts.census. gov/qfd/states/06000.html. 9 Malaysian Biotechnology Corporation, 2007; www.biotechcorp.com.my.  Scott M. Wheelwright, PhD, is president of Strategic Manufacturing Worldwide, Inc., 13119 Glen Brae Drive, Saratoga, CA 95070, 1-408-420-5352, info@smwbiotech.com. Artist rendering of Alpha Biologics facility in Penang. COURTESY OF ALPHA BIOLOGICS.
  • 4. SMW Overview » SMW provides consulting services to biotechnology companies,and related industries,in the areas of process development and manufacturing. From R&D to Phase 3 to distribution,SMW is uniquely quali- fied to help commercialize your products. We provide technical expertise, with the discipline of project management, to help speed critical therapies to market. SMW Services » Process Development • Strategy and planning • Design • Assay method development • Technology transfer • Scale-up • Optimization • Transfer to manufacturing Manufacturing – pilot through commercial • Strategy and planning • Resource allocation • Compliance with cGMP • Risk analysis and reduction • Chemistry, Manufacturing and Controls document preparation • Technology transfer • Facility Construction SMW Strengths » • Over 20 years corporate experience • Expertise in the areas of yeast and bacteria fermentation, monoclonal antibodies, proteins, and viruses • Background in oncology, infectious disease, cardiovascular, wound healing, angiogenesis, and vaccine products • Specialty focus in facilitating outsourcing • International expertise: United States, Asia, Japan and Europe • Global experience with regulatory bodies, including FDA, EU/EMEA, MHLW and WHO • Fluency in Japanese and English We work with companies of all sizes and budgets. Please contact us for more information: Scott M.Wheelwright,Ph.D. info@smwbiotech.com 408.420.5352 www.smwbiotech.com StrategicManufacturingWorldwide,Inc. Bringing Products to Market