Bio-Process Engineering, Testing, Development and Consulting
ISO 9001:2015 Accredited
Bio-Process Engineering, Testing, Development and Consulting
ISO 9001:2015 Accredited
About Us
Our Expertise
bioX provides "Best of Breed" Bio-Process Engineering, Testing, and Development and Early Phase Contract Manufacturing Services. From Analytical Development and Methods Qualification to Feasibility through Detail Design, bioX is a single-source solutions provider.
bioX is the industry leader in Single-Use Technology (SUT) consulting services, including defendable SUT program deployment. The bioX Applications Lab conducts USP/ASTM/ISO product release, physical/mechanical, biological and chemical testing services. bioX also provides pilot-scale manufacturing process feasibility testing and manufacturing operations expertise.
bioX provides early stage Contract and Development Manufacturing Organization (CDMO) services and have a proven track record with multiple end users from Cell Banking through DP bottling.
Project Sectors
Cell and Gene Therapies (CGT)
Enzyme Replacement Therapies (ERT)
mRNA, siRNA, tRNA
Microbiome
ADC
Exosomes
ATMPs
Monoclonal Antibodies (mAb)
Polysaccharide MFG
Materials and Equipment Development
Physical/Mechanical Testing
Chemical Compatibility Testing
Bio-Compatibility/Hemolysis Testing
Cleaning Efficacy
bioX's Quality Policy per ISO9001:2015
bioX is committed to delivering innovative, safe, and effective biotech solutions through scientific excellence, regulatory compliance, and continuous improvement in our process development, product development, and engineering services. This is managed through our 21CFR Part 11 and ISO 9001:2015 compliant Quality Management System (QMS).
About Us
Located in the Greater Boston Area, bioX delivers agile, focused, and relevant Process and Quality Engineering consulting on a global scale. bioX is the industry leader in Single-Use Technology (SUT) consulting. bioX runs a 14,000 sq/ft, ISO-7 applications lab to stress test any bio-process unit operation or execute an entire pilot scale manufacturing feasibility campaign. bioX is an ISO 9001:2015 accredited organization.