Rose BioSolutions is an advanced therapy CDMO providing human immune and stem cells, biospecimens, plasmid DNA, viral vectors, and cell therapy manufacturing. Its integrated capabilities support research, process development, clinical manufacturing, and commercial production.
FDA Registration for Blood and HCT/P
Registration
AABB Accreditation
Good Manufacturing Practice (GMP)
Compliance program
Good Tissue Practice (GTP)
Compliance program
CLIA Requirements
Compliance program
MHRA Investigational Medicinal Products Production License
Registration
FDA Compliance
Compliance program
European Medicines Agency (EMA) Compliance
Compliance program
Health Canada Compliance
Compliance program
GMP
Quality certification
GTP
Quality certification
MHRAIMPPRODUCTIONLICENSE
Quality certification
FDA
Quality certification
EMA
Quality certification
IDT BiologikaFounded in 1921, IDT Biologika is a Dessau-Rosslau-based global CDMO that develops and manufactures vaccines, viral vectors, biologics and sterile injectables from early development through commercial supply. Its particular strength is more than a century of experience working with live viruses, supported by BSL-2 facilities, integrated process development and manufacturing, and in-house quality and analytical services. Now part of SK bioscience, the company employs about 1,600 people and serves pharmaceutical and biotechnology customers as well as governments worldwide.ROCKVILLE, MD
CoJourneyCoJourney is a cell and gene therapy contract development and manufacturing organization that develops and produces plasmids, viral vectors, sgRNA and exosomes from process development through GMP manufacturing and analytical testing. Its distinctive Zero Chrom® column-free plasmid platform is designed for high-purity production while reducing purification time and contamination risk. With more than two decades of team experience, FDA/EMA/NMPA-compliant facilities in Hangzhou and over 100 customers served, CoJourney supports programs from early development through clinical and commercial supply.HORSHAM, PA
Advanced BioScience Laboratories (ABL), IncFrom its Rockville base, Advanced BioScience Laboratories (ABL) develops and manufactures viral products for vaccines, gene therapies, oncolytic therapies and immunotherapies as a contract development and manufacturing organization. ABL brings more than 60 years of experience working with industry, government and academic partners, including over 30 years focused on viral-vector development and GMP production. Its Rockville facility is ISO 9001 accredited for viral drug-substance and aseptically prepared drug-product manufacturing, and the company has translated more than 100 processes from the laboratory bench into GMP suites.POTOMAC, MD
WuXi BiologicsWuXi Biologics is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions for biologics discovery, development, and manufacturing. The company provides integrated services from concept to commercialization, including mammalian and microbial production systems, and operates a global network of cGMP facilities.NORTH RHINE-WESTPHALIA, DE