Oligo Factory Achieves ISO 13485 Certification for Holliston, MA site, Strengthening Support for Molecular Diagnostics
Oligo Factory is an ISO 13485 certified and GMP compliant oligonucleotide CMO in Holliston, MA
With ISO 13485 certification, customers can further trust in the reliability and consistency of our products, empowering them to drive advancements in diagnostics and personalized medicine”
HOLLISTON, MA, USA, June 13, 2024 /EINPresswire.com/ -- Oligo Factory proudly announced today that its Holliston, MA facility has received ISO 13485:2016 certification, marking a significant milestone in its dedication to quality systems that support its clients through custom oligonucleotide solutions.— Chris Boggess, CEO
The attainment of ISO 13485 certification underscores Oligo Factory's commitment to quality, reliability, and compliance in supporting the diagnostics and medical device industry. This certification extends the firm's capability to manufacture and supply essential custom raw materials, including primers, probes, and other oligonucleotides crucial for diagnostic assays.
"In the rapidly evolving fields of molecular diagnostics and precision medicine, oligonucleotides are emerging as vital tools that enhance our ability to detect, diagnose, and treat various diseases with unprecedented precision. Oligo Factory is proud to have supported these customers for almost two decades. We look forward to enabling more advancements with this new level of quality certification." said Oligo Factory CEO, Chris Boggess.
Growth and Expansion
Founded in 2006, Oligo Factory relocated in 2023 to a new purpose-built facility with over 13,000 square feet of laboratory and office space, significantly increasing oligo synthesis capacity by 12-fold and purification and lyophilization capabilities by 10-fold. The ISO 13485 certification complements its GMP ICH Q7 compliance announced in December 2023.
About Oligo Factory, Inc.
Specializing in large-scale custom DNA and RNA oligonucleotide manufacturing (from milligrams to kilograms), Oligo Factory serves clients in life sciences, therapeutics, and diagnostics. The Oligo Factory team includes skilled chromatographers, synthesis chemists, instrumentation engineers and commercialization specialists with more than 30 years of combined experience all dedicated to creating high-quality oligos and providing individualized service for every customer.
Chris Boggess, CEO
Oligo Factory, Inc.
+1 508-275-3561
press@oligofactory.com
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