New Strategies Required to Meet Changing Needs in the Analytical Services Market

The pharmaceutical analytical services market is growing, but the competition is heating up. (Bio)pharmaceutical companies rely on analytical service providers to provide high-quality support for core testing needs so they can best leverage their internal resources. To meet industry needs for high-quality, rapid, cost-effective testing services, BioDuro is now offering clients an enhanced strategy to access its extensive analytical expertise for the support of discovery, formulation, development and manufacturing activities through new standalone analytical services.

Strong growth with increasing competition

Bioanalytical services accounted for the largest share of the global healthcare analytical testing services market in 2015,¹ reflecting the rising percentage of large-molecule drugs in the pharma industry pipeline — a trend that is expected to continue for the foreseeable future. On the other hand, the batch-release testing segment is expected to grow more than any other segment during the next five years, according to Markets and Markets.¹

North America currently dominates the pharmaceutical analytical testing services market due to the large number of well-established service providers and high-quality standards, as well as rapid growth in the biosimilars and biologics segments in the region.¹ The Asia-Pacific market is growing the fastest, however, due to the cost advantages offered by companies in India and China.¹ There are challenges with outsourcing analytical services to the region, particularly with respect to quality and intellectual property. In China, the former is actively being addressed by China’s Food and Drug Administration, which has issued stricter regulations and begun cracking down on noncompliant companies. These aggressive actions are anticipated to drive additional outsourcing to the country in the future.

The strong growth of the pharmaceutical analytical testing services market has attracted many new entrants, leading to steadily increasing competition for well-established, standalone service providers. Today, many contract development and manufacturing organizations (CDMOs), both large and small, that have analytical capabilities to support their development and manufacturing activities, now offer analytical services and some expertise as well. Numerous smaller firms specializing in analytical services only have also entered the market and compete on pricing and possibly shorter turnaround times.

Outsourcing allows redirection of resources

As the complexity, not only of new drug substances, but also of drug development, formulation and manufacturing processes, continues to increase, (bio)pharma companies are pressured to make maximum use of project resources. Outsourcing of an ever-wider variety of essential analytical functions that don’t require extensive training, expertise or equipment has therefore become the norm.

Analytical method development, including optimization and transfer, analytical method validation, release testing, stability studies and associated testing (e.g., micro testing) and raw material testing, are all core services required by all pharmaceutical companies and most frequently outsourced. By doing so, they free up resources for redirection to address more challenging research and product development issues and/or complex/proprietary activities related to specific products. Release, stability and raw material testing are the most commoditized analytical functions and offer the greatest opportunities for cost savings.

There are a few exceptions where the need for specialized expertise and equipment is driving outsourcing. Demand for extractable and leachable (E&L) testing has grown in recent years as the adoption of single-use technologies has become much more widespread at the commercial scale. Demand for API and product characterization are also on the rise. Both E&L analyses and characterization studies require expensive instruments (mass spectrometers and nuclear magnetic resonance imaging systems) and most companies cannot justify the expense of purchasing and maintaining such equipment and the experts required to conduct the analyses and interpret the results. Outsourcing of this testing, which often is the last testing required prior to filing of a new drug application (NDA), is growing.

Quality, cost and turnaround times matter

While cost savings was initially the main driver for outsourcing in the pharmaceutical industry, today (bio)pharma companies seek much more than just reduced project expenses. Indeed, according to the 2016 Nice Insight CDMO Outsourcing Survey (n=587), improving quality is the number one goal, followed by reducing time to market, increasing efficiency and reducing cost.²

Manufacturers seeking analytical testing service providers look for quality in terms of technical performance — i.e., the quality of the data and work performed — as well as with respect to regulatory compliance. In particular, the ability of an analytical testing outsourcing partner to recognize out-of-specification (OOS) materials very early on in a project and proactively deal with such issues is crucial; if caught at a late stage, OOS issues can lead to the derailment of projects.

Cost does remain a factor, of course, particularly for more commoditized services. However, most customers do not consider cost as an independent determiner of partner selection. Rather, the cost versus value equation is the decision driver. Most clients are willing to pay a premium if the service provider offers measurable added value.

For analytical services perhaps more so than other outsourcing activities, rapid turnaround times are crucial to client success. The results of analytical testing are required before many key decisions in the drug development process can be made. Consequently, analytical service providers can impact the progress of a program at all stages, including formulation-selection manufacturing process decisions and release of clinical trial materials, to name a few.

For smaller and emerging (bio)pharmaceutical companies, the ability to provide regulatory expertise can be a real differentiator when it comes to choosing an analytical testing partner. These firms often require assistance with everything from initial new drug applications and NDA filings to addressing questions raised by the relevant regulatory agencies. Analytical service providers that have a deep understanding of the drug development process and extensive knowledge of regulatory requirements, combined with the ability and willingness to provide customized support, are viewed as offering real added value. These companies also appreciate outsourcing partners — including analytical testing service providers — that offer innovative contract options, including creative risk-sharing, dedicated resources (FTE models) and other financial incentive solutions.

New strategy to leverage discovery and development expertise

As a provider of end-to-end solutions for integrated drug discovery and development, chemistry, DMPK, API synthesis and optimization, formulation development and cGMP manufacture of drug products, BioDuro has extensive analytical testing expertise to support all phases of drug development from discovery to clinical-trial material manufacture. The company is implementing a new strategy to leverage these capabilities to meet the growing demand in the pharmaceutical industry for high-quality, rapid analytical testing support with the introduction of standalone analytical services.

With both discovery- and development-related analytical expertise, BioDuro can support clients across the full development cycle, including studies to support discovery and candidate selection; preclinical to clinical activities, including API synthesis, screening and characterization; preformulation and formulation development; and engineering batch and clinical trial material manufacturing efforts. The analytical data drives several critical decisions as one navigates through several CMC drug development processes. Having an expert analytical team equipped with the right know-how and tool box to accelerate scientifically sound decision-making is essential to any program’s success.

By offering standalone services, the company will be able to leverage its analytical expertise to help clients at early stages of their development projects through late-phase clinical trials. One advantage of the analytical arm of a CRO and CDMO like BioDuro is the ability to better understand the physical, chemical and biological properties of the API and drug product as well as the challenges of the formulation and manufacturing process. This inherent expertise will enable the development and optimization of the analytical methods more effectively and efficiently. With this new strategy, BioDuro is also removing most of the barriers generally in place with standalone analytical contract organizations that support different phases of drug development.

Often not well-equipped with knowledge of background information on and experience with the API and dosage form process development, a contract analytical testing laboratory can be handicapped when it comes to selecting the best analytical approach to develop methods, or troubleshooting atypical or out-of-specifications analytical data, among other things. The extensive collaboration approach at the company — along with centers of excellence in chemistry, DMPK, solubility and bioavailability enhancement — will facilitate problem resolution, allowing the identification of analytical problems early on in a project before they become significant issues. As a result, the negative impact that analytical challenges can have on the overall program’s quality, timelines and costs can be minimized.

New clients can also use the standalone analytical services as an effective mechanism for evaluating BioDuro as an outsourcing partner for formulation development, manufacturing and other services. Consequently, the new standalone strategy is anticipated to help grow BioDuro’s business by utilizing various entry points within its continuum of service offerings. Expanding the analytical strategy from being a purely support function to a critical driver of the rest of the business functions within BioDuro is particularly aimed at enhancing the value that the company can provide to its customers.

As a key differentiator, being a smaller CDMO with niche areas of expertise, BioDuro is highly nimble and responsive and capable of forming deep collaborations with smaller/emerging (bio)pharma companies that desire flexibility and responsiveness from their partners and require additional technical and program management support. With its deep knowledge of the drug discovery and CMC drug development process, including its challenges and barriers to success, BioDuro is able and willing to help these partners fill in the gaps in order to accelerate development times.

Conclusion

Demand for analytical testing support is growing within the pharmaceutical industry as biopharmaceutical companies seek to maximize the use of internal resources for highly complex and proprietary activities. BioDuro, with both discovery and development components, has analytical expertise not typically found at other CDMOs that enables the establishment of analytical strategies and the resolution of analytical method challenges earlier on in the development cycle for reduced client-program risk in a more cost-effective manner.

References

  1. Healthcare Analytical Testing Services Market worth 4.13 Billion USD by 2021. Markets and Markets. 30 May 2016. Web.
  2. The 2016 Nice Insight Contract Development & Manufacturing Survey. 2016.

About The Authors

Magdalena Mejillano, Executive VP and General Manager, CMC Solutions, BioDuro

Magdalena Mejillano is a proven industry leader with over 22 years of experience managing analytical contract organizations. She led the significant and consistent growth of PPD’s cGMP laboratory for 19 years, where it became well-renowned for its breadth and depth of analytical capabilities. Prior to joining BioDuro, she served as a management consultant at Bristol-Myers Squibb’s commercial biologics division, leading business process improvement initiatives. At BioDuro, she heads up the global CMC business — including formulation, analytical and clinical trial material manufacturing — and is based in San Diego, CA.
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Lijun Duan, Associate Director of Analytic Development, BioDuro

Lijun Duan has over 10 years of technical and leadership experience in analytical development in the pharmaceutical industry. As Associate Director of Analytical Development at BioDuro, he leads an analytical team with his expertise in analytical methods development and GMP regulatory compliance in different drug product development stages. Prior to joining BioDuro, Lijun was a Senior Group Leader at PPD, managing an analytical group to provide quality analytical method development, validation and quality control testing services to clients in the pharmaceutical industry.
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David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicky Traded and Private companies in the fields of Phammaceuticals, Animal Health and Biotechnology as a Board Member. The last 30 years of his xperience has been in China, Taiwan and Hong Kong building successful igh growth businesses. David Has been Chaiman and CEO for Greater China for Sanofi and Boehringer – Ingelheim as well as the Janssen Corporation since 1991 in China. During this time he build high Growth ousinesses in China through diversified strategies in Innovative Pharmaceuticals. branded Generics. Biotechnology. and Animal Healthcare.

Key highlights in this period indluded building of the first Westem Multinational Biotechnoloqy C.M.O. facility as well as obtaining the first Test CM.OJ MAHI license. Establishment of a number of High tech Vaccine Plants, and R and D facilities in in the field of Animal Health. Signing and development of numerous JV’s as well as Wholly owned Subsidiaries. Mergers and Acquisitions across Phamaceutical’s. Animal Health. and Biotechnology industries

David’s achievement’s in the Healthcare industry and it Growth and development in China is widely recognized By the Chinese Govemnment and the City of Shanghai In 2013 he was awarded the Silver Magnolia ollowed in 2015 the Gold Magnolia award. This was then followed by being awarded in 2017 the Honorary Citizen of Shanghai by 40th People’s Municipal Congress of Shanghai. David Holds a Business Science Degree

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Filippo
Filippo de Vecchi

Director, Advent Partner

Filippo de Vecchi joined Advent in February 2000. He started in the Advent São Paulo office, then moved to Milan in 2002, in 2012 set up the Advent office in Shanghai and in 2016 set up the Hong Kong office. Before joining Advent, he was a senior consultant with Value Partners, in São Paulo and Milan, focusing on strategy and organization in the automotive, energy, cable and media sectors. He began his career at Wasserstein Perella & Co., working as an analyst in the Mergers and Acquisitions department in London and New York. Filippo holds an undergraduate degree cum laude in Economics, with a major in Business Administration, from the LUISS University and an MBA from Columbia Business School, where he currently serves as a member of the Board of Overseers.

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Andrew Li
Andrew Li

Director, Advent Partner

Andrew Li joined Advent in 2012. He previously worked at Warburg Pincus, HSBC PE, Solera Capital and Credit Suisse where he focused on the retail and consumer, healthcare, industrial, and energy sectors. Andrew has worked in finance and private equity throughout the U.S. and China since 1999. Andrew holds a BA from Middlebury College and an MBA from Harvard Business School.    

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Michael Miltenberger
Michael Miltenberger

Director, Advent Partner

Michael Miltenberger  joined Advent in 2011 as an associate on the healthcare team. Following business school, he rejoined Advent’s Boston office, focusing on healthcare investments. Prior to Advent, Michael was a consultant at McKinsey & Company in their Washington DC office, serving a range of healthcare and private equity clients. Michael earned a BA, cum laude, from Harvard College and an MBA from Harvard Business School, graduating with High Distinction as a Baker Scholar and a Harvey Fellow.

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Masood Tayebi
Masood Tayebi, PhD

Director, Operating Partner

Dr. Masood Tayebi is the Founder of BioDuro. He currently serves as CEO of a nationwide real estate portfolio and is a Partner and Chief Executive Officer of the Bridgewest Group. Prior to BioDuro, Dr. Tayebi was Co-Founder and Chairman of Wireless Facilities, Inc. (NASDAQ: WFI), a global leader in telecommunications outsourcing.

Achievements
  • Co-Founder of Wireless Facilities, Inc.

  • Co-Founder of BioAtla, LLC

  • Recipient of the Ernst and Young 2000 Entrepreneur of the Year award in San Diego

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Kewen Jin
Kewen Jin, PhD

Director, Operating Partner

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Amit patel
Amit Patel

Director, Operating Partner

Amit Patel has twenty years of healthcare industry experience with publicly-traded, private equity-backed, and start-up companies in the capacity of executive, board member, advisor, and investor.  He is currently Executive Chairman of Azurity Pharmaceuticals (a NovaQuest Capital Management portfolio company) and a board member at BioDuro (Advent International portfolio company), Tergus Pharma (Great Point Partners portfolio company) and Calyptus Pharma.  Recently, Amit was SVP & President of Dosage Form Solutions at Capsugel, a KKR portfolio company (purchased from Pfizer in 2011 and sold to Lonza in 2017).   

Prior to Capsugel, he worked at Dr. Reddy’s Laboratories, Inc. as EVP & Head of North America, and SVP & Head of Global Corporate Development & Strategic Planning. Earlier, Amit was VP of Corporate Development at CTIS, Inc., and Co-founder & CEO of MedOnTime, Inc. (acquired by CTIS).  He started his career as a strategy consultant with Marakon Associates. Amit holds an M.B.A. degree from Harvard Business School, a B.S. degree in Economics from the Wharton School of Business, University of Pennsylvania, and a B.A.S. degree in Systems Engineering from the Moore School of Engineering, University of Pennsylvania.

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Haijun Dong
Haijun Dong

Chief Executive Officer

Dr. Haijun Dong currently serves as global CEO of BioDuro-Sundia. He previously was CEO for over 5 years at PharmaBlock Sciences Inc., a public company listed in the Shenzhen Stock Exchange (300725.SZ). The positions he held prior to PharmaBlock includes, among others, Senior Scientist at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut; Senior Principal Scientist at Roche in Nutley, New Jersey; Head of DMPK and Drug Safety at Roche China R&D Company in Shanghai; Chief Operating Officer of Eli Lilly China R&D Center in Shanghai.

Dr. Dong received his PhD in organic chemistry from the University of Washington in Seattle, Washington, and MBA from China Europe International Business School in Shanghai. 

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Teo Nee Chuan
Teo Nee Chuan

Chief Financial Officer

Teo Nee Chuan joined us in May 2021 as chief financial officer. Prior to joining us, he was chief financial officer of Huazhu Group from November 2015 to May 2021, and was the chief financial officer for Rnomac International Limited, from November 2011 to August 2015. Mr. Teo worked in DDB Greater China Group, was appointed as the chief financial officer in September 2009, and was additionally appointed as the director of operations in January 2011. He previously served in Focus Media Group and was appointed as the financial deputy director in June 2007. Prior to that, from September 1994 to May 2007, Mr. Teo worked at Ernst & Young and Ernst & Young Business Services Ltd. in various positions in Kuala Lumpur and Toronto, including as a senior manager in the Transaction Advisory Services. Mr. Teo has been an independent director of 111, Inc. (a company listed on the NASDAQ, ticker symbol: YI) since September 2018. Mr. Teo received his Bachelor of Science in Accounting and Financial Analysis degree from The University of Warwick in the United Kingdom in July 1994. He is a Chartered Certified Accountant in the United Kingdom, who has obtained his qualification in July 1998 from The Association of Chartered Certified Accountants, and is a Certified Public Accountant in the United States and Hong Kong, who has obtained his qualification from American Institute of Certified Public Accountants in May 2002 and Hong Kong Society of Accountants in October 2003, respectively.

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TJ
TJ Deng, PhD

President, Discovery

Dr TJ Deng joined BioDuro in the initial stages of the company and helped BioDuro grow to an industry leading discovery services organization. He established and managed several scientific departments, including DMPK, before transitioning to a leader of the business and operations functions. Prior to joining BioDuro, Dr. Deng spent six years at PPD, in positions with increasing responsibilities from scientist to scientific manager.

Achievements

 

 

  • Developed the extractable/leachable capabilities at PPD
  • 18 years industry experience

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Kent Payne
Kent M. Payne, PhD

Chief Executive Officer

Kent is distinguished as a business operator and leader in areas of sales, commercial manufacturing and product development. He has extensive executive experience in M&A as well as successfully running, start up, growth and turn around businesses. This includes both Fortune 500 and Private Equity environments. He combines strong business leadership, successful P&L track record, and technical background to strategically lead and grow enterprise value across Biotechnology and Pharmaceutical market segments. He has successfully led the geographic expansion of businesses into Europe, Asia, and South America in addition to the United States.  He currently serves as CEO for BioDuro-Sundia, LLC (an Advent International company). He also currently serves as a board member for Goodwin Biotechnologies (a Signet Healthcare company). 

Prior Roles

  • President, Global CMC Solutions BioDuro-Sundia, a global
    CRDMO
  • CEO Socorro Pharmaceuticals, LLC, a generic pharmaceutical
    company
  • President Americas, Qualicaps Inc.(a Mitsubishi Chemical Holdings subsidiary)
  • Principal Consultant and Partner at CoreFactor LLC, providing executive strategic, licensing and operational advisory services to clients.
  • Vice President/General Manager Catalent Pharma Solutions, Inc. (a Blackstone Group company formed in 2007, formerly part of Cardinal Health)
  • Progressive leadership responsibility at: Novartis, Monsanto and G.D. Searle.  

Prior Brand Position

  • Board Advisor Vitruvias Therapeutics
  • Board Member Qualicaps, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board member Technophar, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board Advisor, Corporate Strategy Office, Life Science Institute
    Inc. (a wholly owned subsidiary of Mitsubishi Chemical Holdings)
  • Non-executive Chair and Board Member PDS Biotechnology·        (PDSB: NASDAQ)

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John Phillips
John Phillips

Vice President, Business Development (US & EU)

Coming soon…

Achievements

 

  • Coming soon…

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Roy Xu
Roy Xu

Chief Strategy Officer

Roy has over 25 years of healthcare industry experience.  He started his career as an orthopedic surgeon.  Roy joined Eli Lilly as a sales rep in 1997.  Since then he has had various roles in market research, business intelligence, BU head, strategy, regional general management, business development etc., both at Eli Lilly and Boehringer Ingelheim (BI).  Roy also spent more than two years in Germany where he was BI’s Director of Corporate Business and Enabling Strategy.

Roy obtained a bachelor’s degree in Clinical Medicine at Zhejiang Traditional Chinese Medicine University, and an MBA from Zhejiang University.

Achievements

 

  • 25 years of healthcare industry experience including Eli Lily and Boehringer Ingelheim. 
  • Former Director of Corporate Business & Enabling Strategy at oehringer Ingelheim in Germany.

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San Diego

San Diego - BioDuro-Sundia

Our San Diego site is our corporate headquarters. The facility is home to BioDuro-Sundia’s drug product development technologies and has 9 GMP clean rooms. Development and manufacturing operations are conducted for projects up to Phase III clinical trials.

Size: 44,000 sq. ft.
Featured capabilites: Tableting, Coating, Hot Melt Extrusion, Spray Dried Dispersion

11011 Torreyana Rd.
San Diego
CA 92121
United States

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Beijing

BioDuro Beijing

Operating since 2006, our Beijing site is home to BioDuro-Sundia’s first wet chemistry operations. With 300 regular fume hoods and 18 scale-up chemistry hoods the Beijing facility houses most of BioDuro’s chemistry operations, while also hosting labs for biology and monoclonal antibody discovery.

Size: 100,000 sq. ft. 
Featured capabilities: Radioactivity Lab, Monoclonal Antibody Discovery, Medicinal Chemistry

No. 29 Life Science Park Road
Changping District Beijing,
102206
P.R. China

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Shanghai-Waigaoqiao

BioDuro- Shanghai Facility

Established in 2012, BioDuro-Sundia’s Shanghai facility has been growing with its departments. The cutting edge facility contains labs for ADME, bioanalysis, in vitro assays and translational research. The site includes a 18,000 sq. ft vivarium and 20,000 sq. ft of office space.

Size: 92,000 sq. ft.
Featured capabilities: Scale-up Chemistry, Discovery Biology, DMPK, In Vivo Pharmacology

No. 233 North Fu Te Road
Waigaoqiao Free Trade Zone
Shanghai, 200131
P.R. China

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Cathy Yen
Cathy Yen

Director, Operating Partner

Cathy joined the Board of Directors of BioDuro-Sundia in 2020, with the Advent-led acquisition of Sundia and creation of BioDuro-Sundia. Prior to that, she was Chairman of the Board at Sundia Meditech Group, where she was the key architect of Sundia’s strategic vision and growth. Under her leadership, Sundia solidified its position as one of the leading pre-clinical CROs in China.

Prior to Sundia, Cathy had a distinguished career as a seasoned venture capitalist, having led numerous investments in high-growth companies in Asia. Cathy served as a Partner of AsiaVest Partners, TCW/YFY Ltd., a global venture capital firm, for over a decade, Vice President at Global Financial Services, Vice President at Crimson Ventures/Chinatrust Bank and Senior Manager at Fortune Capital. She brings over 20 years of experience in corporate finance, accounting, strategic planning and private equity investments. 

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Wuxi

Wuxi - BioDuro

Established in 2019, BioDuro-Sundia’s fully integrated discovery facility located at the heart of Jiangsu Wuxi Life Science & Technology Industrial Park with plans of growing staff to 1000+ scientists.

Size: 300,000 sq. ft.
Featured capabilities:
Discovery Chemistry & Biologics, Biology, DMPK, Pharmacology, CMC Services

no.1699,Huishan avenue
Huishan Economic 
Development Zone,Wuxi
P.R. China

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Hebei

Hebei - Sundia

Established in 2011, this pilot plant this handles mg to kg scale up.

Size: 45,208 sq. ft.

Featured capabilities: SFFS Chemistry: mg to kg scale up
(150 hood)

238 Changjiang Road
Shijiazhuang,
Hebei province
P.R. China

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Taiwan,China

Taiwan Sundia

Our site in Taiwan, China supports Discovery Biology and Chemistry.

Size: 3,352sq.ft.
Featured capabilities: Chemistry;Biology

7F, No. 107, Sec. 4
Ren Ai Road,
Da-an District,
Taipei, Taiwan, China

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