Highly Synergistic Transaction Augments BioAgilytix’s Ability to Support All Phases of Large Molecule Biotherapeutic and Biosimilar Global Studies; Onboards IPM’s Renowned Immunogenicity, PK, and PD Expertise
Combination Brings the Rigor of Science, Service, and Quality for Which Both BioAgilytix and IPM are Known to Clients on Both Continents; IPM to Become BioAgilytix’s European Headquarters
FEBRUARY 22, 2016—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the acquisition of IPM Biotech, a German-based bioanalytical contract research laboratory renowned for its expertise in large molecule bioanalysis, particularly in the area of immunogenicity. The transaction not only expands BioAgilytix’s global footprint, with IPM’s newly planned GLP laboratory facility as its European headquarters, but also brings on board IPM’s rich immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) expertise to complement BioAgilytix’s world-class capabilities in biomarkers, cell-based assays, and immunogenicity & pharmacokinetics. Each company has experienced successful organic growth through a strong commitment to scientific quality, and together will offer this same rigor of science and service to customers across continents, with expanded capabilities to support all phases of large molecule global studies.
As a GLP/GMP laboratory specializing in assay development and validation for biotherapeutics, BioAgilytix has forged a premier reputation for solving complex large molecule challenges, and already boasts an impressive customer base. BioAgilytix leadership sees the integration of IPM’s scientific team and technologies as the next step in more fully serving its customers’ global study needs. “BioAgilytix is currently a trusted partner to 21 of the top 25 global pharmaceutical and biotech companies,” said Dr. Afshin Safavi, Founder and Chief Scientific Officer of BioAgilytix. “The addition of IPM’s deep scientific expertise and European presence will enable us to more easily support these customers, and new global clients, who have sites on both continents – particularly in Phase II and III trials.”
In addition to providing a site for BioAgilytix’s European headquarters, the acquisition integrates the IPM Biotech team’s specialized expertise in immune mediated diseases and disorders. Led by co-founder Dr. Arno Jens Kromminga, a highly esteemed pioneer and leader in immunological assays, IPM was involved in the first cases of immunogenicity and brought the first biosimilar erythropoietin (EPO) to approval in Europe. The company also supported the first biosimilar EPO submission in the U.S. “The 20+ years of experience IPM brings in assay development and validation work for immunogenicity, PK, and PD is a perfect complement to BioAgilytix’s best-of-breed large molecule bioanalytical capabilities,” said Dr. Kromminga. “As a merged company we will truly be the most scientifically advanced CRL, capable of supporting global studies for any type of large molecule need.”
Jim Datin, Chief Executive Officer of BioAgilytix, noted that while IPM Biotech is continuing operations at its current GLP laboratory, construction of a new advanced laboratory facility is also underway. This new site will add GMP certification, and expand IPM’s capacity to more than triple its size by the end of the year. “When completed this fall, IPM’s new facility will be the most technologically advanced bioanalytical laboratory in Europe supporting biotherapeutics development. We will be duplicating the expert resources and extensive platforms already available in BioAgilytix’s premier U.S. laboratory, making it our European headquarters. This gives customers in both North America and Europe ready access to our top-caliber scientific expertise and technology – plus the additional specialized services that the IPM team brings to the table.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. Located in North Carolina’s Research Triangle area, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, and GLP, as well as product release testing under GMP.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 21 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
About IPM Biotech
IPM Biotech is a science-driven bioanalytical contract research laboratory specializing in immune mediated diseases and disorders. The German-based GLP laboratory combines novel technologies with deep scientific expertise in immunological interactions to develop and validate a wide range of assays for sensitive and specific quantitation of biological drugs.
A leader in the areas of immunology and erythropoietin, IPM was involved in the first cases of immunogenicity, brought the first biosimilar EPO to approval in Europe, and supported the first biosimilar EPO submission in the U.S.