Regulatory agencies require microbial cell bank manufacturers to ensure continued stability and safety of cell lines that produce products for human use. Avance Biosciences, Inc. offers comprehensive services for bacterial cell lines at all stages of production under GMP/GLP regulatory compliance. All services can be performed at research grade or under GLP and GMP regulations promulgated by the US FDA (21 CFR Part 58 and Part 210/211), OECD, European Commission, and Japanese agency.
Avance Biosciences has been providing microbiological services of all types since the inception of our company. We are extremely experienced in all types of services including marker retention, lytic and lysogenic phage detection, bacterial viability determination, strain identity testing, purity testing, API 20E identification, and gram staining. Additional testing is available.
All Avance Services Include
Experienced scientists functioning as project managers or study directors
Controlled laboratory environment to prevent cross-contamination
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Projects customized and tailored to suit your needs
Independent quality unit assuring regulatory compliance
Transparent process flow and weekly report on project progress
Professional project reports ready for regulatory filing
Fast turn-around time & Competitive pricing