MANUFACTURERS OF PHARMACEUTICALS AND DIAGNOSTICS CONTRACT MANUFACTURING SERVICE PROVIDERS

Biomanufacturing in North Carolina C O M PA N Y PRODUCTS L O C AT I O N C O M PA N Y SERVICES L O C AT I O N

Biotechnology companies throughout North Carolina are using living cells to
produce medicines, vaccines, diagnostics, enzymes, amino acids, veterinary Alpharma USPD Pharmaceuticals Lincolnton Broad range of analytical and manufacturing
medicines and related products that improve our lives, create jobs and boost our AaiPharma services Wilmington
Banner Pharmacaps Pharmaceutical gel caps High Point
economy. The making of these biological products is called biomanufacturing or Cardinal Health Analytical services Morrisville
bioprocessing. Baxter Healthcare IV
Systems Intravenous solutions Marion Bulk chemical synthesis, fill and finish, and
North Carolina is a national leader in this DSM Pharmaceuticals aseptic filling services Greenville
“North Carolina’s Bespak Drug-delivery devices Apex
growing industry. Sixteen companies have Sterile solutions and emulsions for infusion and
business climate, low biomanufacturing operations in North BioMerieux Diagnostic kits Durham Hospira nutrition therapy Clayton
tax burden and high- Carolina, and at least 30 other companies Carolina Medical Products Ointments, powders, non-injectable solutions Farmville Development and manufacture of topical
skill work force make are engaged in related manufacturing of
Cytosol Ophthalmics Sterile balanced salt solutions Lenoir Harmony Labs pharmaceuticals and cosmeceuticals Landis
this region an attractive pharmaceuticals, diagnostics and medical de-
Eisai Pharmatechnology Alzheimer’s drug RTP LabCorp Clinical laboratory services RTP, Burlington
vices. These companies employ an estimated
place for industries 20,000 people. In addition, tens of thousands Metrics Analytical services Greenville
Broad range of products in solid, oral dosage
like biotechnology and of North Carolinians work in companies that Eon Labs forms Wilson Pharmacore Organic chemical synthesis High Point
biomanufacturing.” provide goods and services in support of bio-
GBF Medical Group Diagnostic kits Greensboro
manufacturing and related pharmaceutical Pisgah Labs Organic chemical synthesis Pisgah Forest
— NORTH CAROLINA GOVERNOR
MIKE EASLEY manufacturing. GlaxoSmithKline Drug formulation and packaging Zebulon
Industry, government and academia are working to plan and implement a na-
Hospira Injectable solutions and drugs Rocky Mount
Biomanufacturing jobs pay well. Entry- tionally unique training program through the North Carolina Biomanufacturing
level bioprocess technicians typically earn $25,000 to $30,000 and move up Leiner Health Products OTC pharmaceuticals Wilson and Pharmaceutical Training Consortium, a partnership of universities, commu-
to $50,000 after five years. The average salary for these positions in North Medtox Diagnostics Drug testing kits Burlington nity colleges, industry and the Biotechnology Center. The program will address
Carolina is well above the average pay for other manufacturing jobs, which are training across all the relevant scientific, technical and engineering disciplines at
generally declining in number. In 2003, the average annual wage for employees Merck Manufacturing Pharmaceuticals Wilson all levels from Certificate or Associate Degree to Ph.D. The goal is to train 2,000
at biopharmaceutical manufacturing businesses in North Carolina was $70,567, Microban Products Anti-microbial polymeric additives Huntersville to 3,000 students each year.
according to the N.C. Employment Security Commission.
NittaGelatin USA Gelatin powder for pharmaceuticals and food Fayetteville North Carolina State University in Raleigh will build and equip a $36 million
Novo Nordisk Biomanufacturing Training and Education Center (BTEC) scheduled to open
A growing industry Pharmaceutical Industries Human insulin formulation and sterile filling
Purdue Pharmaceuticals Pain relief and asthma drugs
Clayton
Wilson
in January 2007. Plans call for a 100,000-square-foot plant that will provide
hands-on experience in a pilot scale, Good Manufacturing Practices (GMP) en-
As more biopharmaceuticals and other products of biotechnology move from vironment similar to an industrial setting. North Carolina Central University in
the laboratory to the marketplace, the demand for biomanufacturing capacity is Shionogi Qualicaps Pharmaceutical gel caps Whitsett Durham will receive $19.1 million for the Biomanufacturing Research Institute
expected to increase. North Carolina is well positioned to capture a large share TriPath Imaging Burlington and Technology Enterprise (BRITE) to open in January 2007. BRITE will in-
of this growing market. The North Carolina (+ TriPath Oncology) Medical reagents (Durham) clude a 65,000-square-foot research laboratory and classroom facility that will
Biotechnology Center, in partnership with conduct research, teach and train at all levels in biotechnology and biomanufac-
Tyco Healthcare
the state Department of Commerce and other turing. The North Carolina Community College System will receive $9.4 million
Mallinckrodt Acetaminophen Raleigh
organizations, is aggressively promoting the re- for BioNetwork, a network of six centers statewide that will train workers in
tention, expansion, and attraction of biomanu- Vintage Pharmaceuticals Pharmaceuticals Charlotte
biotechnology, pharmaceutical and life sciences and will channel students into
facturing companies. the BTEC and BRITE programs for additional training.
In recent years three major biopharmaceuti- Other biomanufacturing plants with established operations in North Carolina Funding is being provided by the non-profit Golden LEAF, a foundation that
cal manufacturers — Diosynth RTP, Biogen also have expanded. They include Wyeth Vaccines, which operates one of underwrites economic development activities using half of the state’s tobacco
Idec and Merck & Co. — were brought to the world’s largest vaccine facilities in Sanford, and Newco Plasma Services settlement money. Golden LEAF committed $60 million in 2003. The General
North Carolina. Diosynth, one of the world’s Biotherapeutics (formerly Bayer), which operates the world’s largest blood
largest contract biomanufacturers, carries out fractionation plant in Clayton. Several new biomanufacturing plants also are
process development and drug production for coming online in North Carolina. In 2004 Biolex opened a therapeutic protein
biopharmaceutical companies. Biogen Idec, biomanufacturing plant in Pittsboro, Embrex dedicated a poultry vaccine plant
which operates one of the world’s largest cell- in Laurinburg, AlphaVax announced plans to build a human vaccine plant in
culture facilities, manufactures the multiple Durham, and KBI BioPharma, a contract biomanufacturer, opened biopharma-
sclerosis drug Avonex® and the psoriasis drug ceutical development services laboratories in Durham.
Amevive®. Together, these two companies
have created about 1,000 new jobs for North
Carolinians, and both continue to expand.
Merck broke ground in October 2004 for a
Preparing the work force
Biomanufacturing plants are complex operations that typically run 24 hours
vaccine-manufacturing plant in Durham that is
a day, seven days a week, under stringent regulation by the Food and Drug
expected to employ at least 200 people when it
Administration. Having highly trained technicians who can operate these plants
comes online in 2008.
efficiently and in compliance with FDA rules is crucial to the growth and success
of biomanufacturing companies.
 Assembly is expected to provide ongoing opera-
Building a biomanufacturing community tional funds. Industry is providing millions of dol-
lars of in-kind services and equipment.

Biomanufacturing
The state’s work force training initiative is part of a highly capable infra-
structure that supports the biomanufacturing industry in North Carolina In addition to this training initiative, the
and makes the state an attractive location for biomanufacturing com- Biotechnology Center has worked with indus-
panies. The biomanufacturing community includes several architecture, try and the North Carolina Community College
construction, engineering, instrumentation System to develop the BioWork© course for training
entry level bioprocess technicians in bioprocess,
“We’re determined that and consulting firms that design, build,
pharmaceutical, and chemical manufacturing. This
North Carolina will upfit and validate bioprocessing plants in 128-hour course, taught by the community colleges,
have the world’s best- compliance with FDA requirements. It also covers basic science, cGMP, and manufacturing
trained work force for includes a dynamic chapter of the Society
of Life Science Professionals, a large
technology, giving students the background they
need to learn quickly and effectively on the job.
A HIGH GROW TH I N DUS TRY
biomanufacturing.” The course is offered to the public and is used by
— DR. LESLIE ALEXANDRE,
PRESIDENT AND CEO
and active chapter of the International
Society of Pharmaceutical Engineers, and
companies for in-house training of new hires and
incumbent workers.
FOR NORTH CAROL I N A’S
NORTH CAROLINA
BIOTECHNOLOGY CENTER.
a Bioprocessing and Process Development
Focus Group. The Focus Group, sponsored
by the Biotechnology Center, provides a dedicated forum for process
Several community colleges have Associate of
Applied Science degree programs in biotechnology;
21S T CEN T URY ECO NOMY
bioprocess, chemical, and pharmaceutical manufac-
development scientists and engineers in the state to discuss issues,
turing technology; and laboratory technology. And
challenges and developments in biomanufacturing. Other specialized many university departments across the state have
networking groups for entrepreneurs and scientists further enrich the B.S. degrees or areas of concentration in all the
intellectual infrastructure. foundational disciplines supporting bioprocess and
pharmaceutical manufacturing.

BIOMANUFACTURERS The state’s training initiatives have earned wide

recognition for North Carolina’s biotechnology
C O M PA N Y PRODUCTS L O C AT I O N work force. The Milken Institute’s 2004 Biotech
Ajinomoto USA Amino Acids Raleigh Index report ranked the Research Triangle area
No. 1 in the nation in human capital and biotech-
AlphaVax Vaccines Durham
nology work force.
Archer Daniels Midland Citric acid Southport
Argos Therapeutics Therapeutic vaccines Durham
Research
Contact us
Biogen Idec Multiple sclerosis and psoriasis drugs Triangle Park For more information about biomanufacturing
Biolex Therapeutic proteins Pittsboro opportunities in North Carolina, contact Dr. Ken
Tindall, Senior Vice President for Science and
Corn Products Business Development. For information on work
International High-fructose corn syrup and starch Winston-Salem
force training, contact Dr. Kathleen Kennedy, Vice
Research President of Education and Training.
Diosynth RTP Contract biopharmaceutical manufacturing Triangle Park
Embrex Poultry vaccines Laurinburg
Greer Laboratories Allergenic extracts, vaccines Lenoir
I M A G E S CO U R T E S Y O F B I O G E N I D E C , B I O L E X , D I O S Y N T H , A N D E M B R E X

KBI BioPharma Contract biopharmaceutical manufacturing Durham

Merck & Co.* Vaccines Durham
MWG Synthetic nucleic acids High Point
Newco Plasma Services
Biotherapeutics Blood and plasma-related therapeutics Clayton
Novozymes Industrial enzymes Franklinton
Wyeth Vaccines Vaccines Sanford

* Merck broke ground in October 2004 with a 2008 completion date. 15 TW Alexander Drive • PO Box 13547
Research Triangle Park, NC 27709-3547

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919-541-9366 • fax 919-990-9544

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