Service overview


To discuss your project
please contact
info@iba-go.com



cGMP: Current Good Manufacturing Practice is a set of rules to ensure identity, potency, safety and purity of the product.








cGMP processes are carried out in respective clean rooms

IBA Biologics offers a variety of custom services (non-cGMP or cGMP on demand)

Consulting
Based on our expertise and knowledge in process development we are ready to assist you with an on-site analysis and evaluation of your project.

Construction of stable recombinant strains and cell lines
Strains and cell lines for the production of biologically active recombinant proteins using IBA’s world-wide patented Strep-tag® technology.

Vector construction
Vector construction for an efficient delivery of the gene of interest in a given cell line according to customer-specified needs.

Quality control
Development and validation of analytical procedures for the determination of identity, purity, safety, potency and content for in-process control and lot release testing.

Production of pre-clinical material for toxicological investigations
Process design and optimization for a rapid change-over to a production for clinical phases.

Production of clinical material for all phases of clinical trials
Complete process validation; production of bulk active pharmaceutical ingredients (API).

Microbial fermentation and cell culture
Production of non-cGMP-grade and cGMP-grade bulk material in BL1 and BL2 culture adaptation to serum-free or protein-free media; process development; optimization and scale-up; process validation; cultivation and primary separation options for microbial processes from laboratory scale up to production scale; cultivation in various bioreactor geometries.

Downstream processing (DSP)
Primary separation, purification and polishing of proteins and nucleic acids. The comprehensive range of downstream processing services we offer include laboratory, pilot and production scale: cell harvesting and disruption; recovery and solubilization of inclusion bodies; microfiltration and ultrafiltration; chromatography (size exclusion, ion exchange, affinity); formulation, freeze drying and lyophylization.



Order information
for a quote please contact info@iba-go.com



top