BioAgilytix
BioAgilytix is a contract research organization (CRO) focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics.[1] As a CRO with its global headquarters in Durham, North Carolina, BioAgilytix provides testing to support biomolecular studies and drug development programs and focuses on diagnostic and development services such as pharmacokinetics (PK), immunogenicity and biomarkers. Diagnostic testing services are provided via the company’s CLIA-certified, CAP-accredited laboratory in Boston, MA.[2][3][4][5]
Bioanalytical capabilities are provided by BioAgilytix’s lab services, including discovery, pre-clinical/clinical development, manufacturing and post-marketing surveillance. The company employs scientists in the US, Europe and Australia, with a focus on assay development, qualification and validation.[6]
BioAgilytix provides clinical assays, diagnostics, and viral and antibody testing services.[7] The company has also supported innovations in the development of drugs and promising clinical candidates in the areas of oncology, neurology, metabolic and autoimmune diseases.[8]
BioAgilytix also is responsible for advancing cell and gene therapies.[9] Support for CAR T therapy programs has allowed the company to contribute to the field of cellular immunotherapies that utilize modified T lymphocytes to treat certain types of cancer.[10]
The global collective of labs is home to a range of equipment for large and small molecule bioanalysis, including Meso Scale Discovery Electrochemiluminescence (MSD-ECL), flow cytometry, real-time PCR/quantitative PCR (PCR) for preclinical/clinical drug development and advanced laboratory automation systems.[1]</ref>
In addition, the company offers plant-based biotechnology and agriculture-related bioanalytical services, supporting field trials under non-GLP and GLP.[1]</ref> It supports research and development with data analysis, protein expression testing, and by defining methods, reagent qualifications and method transfer protocols.[11] These services are designed to support simpler, more efficient crop production and management.[12]
| Bioanalytical Laboratory | |
| ISIN | 🆔 |
| Industry | Contract Research Organization
Biotechnology Pharmaceuticals Life Science Bioanalysis Diagnostic Testing Agricultural Biotechnology |
| Founded 📆 | 2008 |
| Founder 👔 | |
| Headquarters 🏙️ | Durham, North Carolina (USA Headquarters) Hamburg, Germany (European Headquarters) |
Area served 🗺️ | |
Key people | Jim Datin (President & Chief Executive Officer)
Sean Blake (Chief Information Officer) Dominic Marasco (Chief Commercial Officer) Mark Bethers (Senior Vice President, HR) Thomas Zajkowski (Chief Financial Officer) |
| Services | Large Molecule Bioanalysis
Small Molecule Bioanalysis Biomarkers Immunogenicity Pharmacokinetics Cell-Based Assays Diagnostic Testing Services |
| Members | |
Number of employees | 850+ Worldwide |
| 🌐 Website | https://www.bioagilytix.com/ |
| 📇 Address | |
| 📞 telephone | |
History
BioAgilytix was launched in 2008 with a team of 10 employees, in Durham, NC. Dr. Afshin Safavi is a co-founder and board member of BioAgilytix. Prior to founding BioAgilytix, he was the Director of Ligand Binding and Immunoassay, operating under GLP at AAIPharma. Dr. Safavi was a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International.[13]
2016 IPM Biotech Acquisition
In 2016, BioAgilytix acquired IPM Biotech, a German bioanalytical contract research laboratory that focuses on immune-mediated diseases and disorders. The acquisition assisted in BioAgilytix’s immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK) capabilities to support large molecule global studies. It also provided the company with IPM Biotech’s GLP laboratory, which became its European headquarters.[14]
2017/2018 Expansion
The BioAgilytix facility increased in size by 21,000 square feet, doubling its cell culture facility. The company then revealed an expansion of its Durham headquarters in Fall 2018. The renovation of a 21,173 square foot building next to the company’s existing structure provided more lab space. At the time, the project expanded the organization’s campus to a total of 69,000 square feet. It was named a 2018 Leaders in Diversity Award winner by Triangle Business Journal.[15]
Cambridge Biomedical Acquisition
BioAgilytix announced the acquisition of contract research organization Cambridge Biomedical in November 2019. The acquisition added Cambridge Biomedical’s CLIA-certified, CAP-accredited, GLP-compliant facility to the organization, along with its bioanalytical scientists. In kit production, diagnostics and a molecular suite of PCR platforms were made available to BioAgilytix customers as well.[16]
2020-2021 Expansion
In October 2020, BioAgilytix announced plans to add 878 jobs to its Durham location. It invested $61.5 million in its global headquarters, funded in part by a Job Development Investment Grant (JDIG), a 12-year agreement that also authorized a potential reimbursement of up to $18,885,000, accounting for newly generated tax revenue.[17]
MicroConstants Acquisition
In 2021, San Diego-based MicroConstants, a provider of bioanalytical testing services, method development, validation, and sample analysis for small and large molecule therapeutics and biomarkers using LC/MS/MS, HPLC, immunoassay (including multiplexing and high sensitivity SIMOA) and qPCR techniques, signed an agreement to become part of BioAgilytix. Financial details of the acquisition were not announced. MicroConstants will now be known as BioAgilytix San Diego.[18]
360biolabs® Acquisition
In 2021, following Australian Foreign Investment Review Board (“FIRB”) approval, BioAgilytix officially closed the purchase of 360biolabs®. The acquisition of the company, now known as 360biolabs, a BioAgilytix company, expands BioAgilytix’s capabilities into first-in-human trials (FIH), early-phase clinical trials and adds additional capacity by joining 360biolabs® in Melbourne and Brisbane with its existing laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California and Hamburg, Germany.[19]
Awards
2010 - BioAgilytix was named a finalist for North Carolina Companies to Watch by The Council for Entrepreneurial Development (CED)[20]
2010 - BioAgilytix was named winner of Best Places to Work by the TRIANGLE BUSINESS JOURNAL.[21]
2011 - BioAgilytix was named winner of Best Places to Work by the TRIANGLE BUSINESS JOURNAL.[22]
2011 - BioAgilytix receives the Fast 50 award (#11) by TRIANGLE BUSINESS JOURNAL.[23]
2014 - BioAgilytix was awarded CRO of the Year by the TRIANGLE BUSINESS JOURNAL[24]
2014 - BioAgilytix was named winner of Leaders in Diversity award by the TRIANGLE BUSINESS JOURNAL[25]
2014 - BioAgilytix was ranked #13 for TRIANGLE BUSINESS JOURNAL’s Fast 50 award.[26]
2016 - BioAgilytix named as a finalist for 2016 Scrip Awards for Best CRO[27]
2018 - BioAgilytix was named Leaders in Diversity Award winner by the TRIANGLE BUSINESS JOURNAL[28]
2018 - BioAgilytix ranked #24 for the Fast 50 Award by the TRIANGLE BUSINESS JOURNAL[29]
2018 - BioAgilytix ranked #1833 overall for Fastest Growing Private Companies in America by INC 5000.[30]
2019 - BioAgilytix ranked #32 TRIANGLE BUSINESS JOURNAL’s Fast 50 award.[31]
2020 - BioAgilytix is named #24 Fast 50 Award by the TRIANGLE BUSINESS JOURNAL.[32]
2020 - BioAgilytix named Fastest Growing Private Companies in America (#2951) by INC. 5000.[33]
2021 - BioAgilytix named winner of the Leaders in Diversity Awards by the TRIANGLE BUSINESS JOURNAL.[34]
2021 - BioAgilytix was named INC. 5000’s Fastest-Growing Private Company in America (#1939 overall).[35]
Locations
USA Headquarters - Durham, NC
BioAgilytix’s USA headquarters, in North Carolina’s Research Triangle Park, has the capacity to support discovery, preclinical, clinical and manufacturing trial phases. Scientists, Quality Assurance professionals and other technological experts contribute to R&D at this 78,600+ square foot facility.[36]
Location: 2300 Englert Drive, Durham, NC, 27713[37]
Boston Lab - Boston, MA
BioAgilytix’s Boston Laboratory is an 18,453 square foot facility that houses BioAgilytix Diagnostics, a New York State-licensed Boston laboratory that is CLIA-certified and CAP-accredited. Using FDA-cleared assays and laboratory-developed tests (LDTs), the lab performs infectious disease, parasite-borne infection and vitamin testing as well as diagnostic immunology.[38]
Location: 1320 Soldiers Field Road, Boston, MA 02135[39]
EU Headquarters - Hamburg, Germany
At BioAgilytix’s EU headquarters, advanced laboratory facilities are focused on assay development and validation, sample analysis and lot release testing. Biomarker services support global disease studies. Operational since 1996, the Hamburg lab is currently at 17,620 square feet in size.[40]
Location: Lademannbogen 10, 22339 Hamburg, Germany[41]
BioAgilytix San Diego - San Diego, CA
In 2021, BioAgilytix acquired MicroConstants, now known as BioAgilytix San Diego. In addition to its West Coast location, the new lab provides method development, validation, and sample analysis for small and large molecule therapeutics and biomarkers. The business focuses on bioanalytical testing services with over 20 years of experience and will complement BioAgilytix’s contract research services for the pharmaceutical and biotech industry.[42]
Location: 9050 Camino Santa Fe, San Diego, CA 92121[43]
360biolabs, a BioAgilytix company - Melbourne & Brisbane, Australia
BioAgilytix Labs, LLC, recently announced that it has acquired 360biolabs®, a Contract Research Organization in Melbourne, Australia. Located in Australia’s biomedical and clinical research hub, 360biolabs offers virology and immunology services, with BSL 2 and 3 laboratories, biomarker and immune monitoring capabilities with a flow cytometry suite, molecular biology PCR suite and bioanalytical LC-MS/MS small molecule capabilities.[44]
Location: 85 Commercial Rd, Melbourne VIC 3004, Australia[45]
Location: 37 Kent St. Woolloongabba, Queensland, 4102 Australia[46][48]
References
- ↑ 1.0 1.1 1.2 "Gov. Cooper Announces 878 New Jobs for Durham Expansion" (PDF). Sync News & Opportunities From N.C. Commerce. December 14, 2020.
- ↑ "22D0926993 CLIA NUMBER - Bioagilytix Diagnostics". healthprovidersdata.com. Retrieved 2021-11-10.
- ↑ "22D0926993 CLIA NUMBER - Bioagilytix Diagnostics". healthprovidersdata.com. Retrieved 2021-11-10.
- ↑ "The 9 fastest-growing lab companies". www.beckershospitalreview.com. Retrieved 2021-11-10.
- ↑ "Caledonia Investments acquires minority stake in BioAgilytix". QuotedData. 2019-03-07. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2020/12/07/fast-growing-companies-raleigh-durham-are-hiring.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ Marusina Ph.D., Kate (May 1, 2016). "Paving the Road for Clinical Biomarkers". Genetic Engineering & Biotechnology News.
- ↑ www.cms.gov https://www.cms.gov/apps/clia/clia_start.asp?CLIANum=22D0926993&isSubmitted=clia2. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Accredited Laboratory and Biorepository Directory". College of American Pathologists. Retrieved 2021-11-10.
- ↑ "22D0926993 CLIA NUMBER - Bioagilytix Diagnostics". healthprovidersdata.com. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2018/09/20/durham-s-bioagilytix-continues-durham-expansion.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Life science firm BioAgilytix is adding 878 jobs in Durham, investing $61.5M | WRAL TechWire". 2020-10-29. Retrieved 2021-11-10.
- ↑ WTVD (2020-10-29). "RTP expansion will bring 878 new jobs to local biotech company with $96K average salary". ABC11 Raleigh-Durham. Retrieved 2021-11-10.
- ↑ Writer, GEN Staff (2016-02-22). "BioAgilytix Acquires IPM Biotech". GEN - Genetic Engineering and Biotechnology News. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2018/09/20/durham-s-bioagilytix-continues-durham-expansion.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Triangle-based BioAgilytix Acquires Cambridge CRO, Plans Hiring, More Acquisitions | North Carolina Biotechnology Center". www.ncbiotech.org. Retrieved 2021-11-10.
- ↑ "Life science firm BioAgilytix is adding 878 jobs in Durham, investing $61.5M | WRAL TechWire". 2020-10-29. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2021/08/18/bioagilytix-buys-microconstants.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "360biolabs purchased by international contract research laboratory BioAgilytix Labs". Alfred Research Alliance. 2021-08-17. Retrieved 2021-11-10.
- ↑ "Council for Entrepreneurial Development names '25 companies to watch' | WRAL TechWire". 2011-08-08. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/stories/2010/09/20/daily50.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2011/08/30/tbj-unveils-2011-best-places-to-work.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/print-edition/2011/11/18/11---bioagilytix-labs-inc.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/print-edition/2014/05/23/life-sciences-awards-bioagilytix-labs.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/blog/2014/08/tbj-2014-leaders-in-diversity-awards-winners.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2014/11/18/2014-fast-50-winners-revealed.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "San Diego CRO named as finalist for 2016 Scrip Awards Best CRO – Niche Providers!". Biocom CRO. 2016-09-27. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2018/09/28/2018-leaders-in-diversity-awards-winners-companies.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2018/11/09/2018-fast-50-awards-winners-21-30.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "15 Fastest Growing Private Life Science Companies in the US (BioSpace.com) | BioPoint, Inc". 2018-08-23. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2019/11/21/tbjs-fast-50-award-winners-31-40.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2020/12/04/2020-fast-50-awards-no-24-bioagilytix.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Everything You Need to Know to Start and Grow Your Business". Inc.com. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2021/09/09/2021-leaders-in-diversity-awards-bioagilytix-labs.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Check out BioAgilytix Labs on Inc.com". Inc.com. Retrieved 2021-11-10.
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2020/10/29/bioagilytix-picks-durham-over-massachusetts-for-8.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ "Scientist - outsource everything but the genius". Scientist.com. Retrieved 2021-11-10.
- ↑ https://www.signalhire.com/companies/cambridge-biomedical-inc
- ↑ "Bioagilytix Labs, LLC". www.buzzfile.com. Retrieved 2021-11-10.
- ↑ "BioAgilytix acquires IPM Biotech". www.manufacturingchemist.com. Retrieved 2021-11-10.
- ↑ https://www.dnb.com/business-directory/company-profiles.bioagilytix_europe_gmbh.4428c2d708561847503a9bd3f5c148e7.html
- ↑ www.bizjournals.com https://www.bizjournals.com/triangle/news/2021/08/18/bioagilytix-buys-microconstants.html. Retrieved 2021-11-10. Missing or empty
|title=(help) - ↑ https://www.dnb.com/business-directory/company-profiles.microconstants_inc.dbcdbb53fc1ee9d055f86f14b2a3ce61.html
- ↑ https://www.contractlaboratory.com/labclass/directories/laboratories.cfm?360biolabs&i=1BFD9547C2A191DB8953C4645B5D3E62
- ↑ https://www.dnb.com/business-directory/company-profiles.360_biolabs_pty_ltd.b725d92c1a27e1db6301bdebd79037b0.html
- ↑ https://www.tri.edu.au/contact
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