BioConvergence LLC Development, Analytical and Testing Services ...
BioConvergence LLC Development, Analytical and Testing Services Overview The Product and Analytical Development Laboratory at BioConvergence LLC offers formulation assistance and technical services to its clients in the pharmaceutical and biotech business sectors. Development and Analytical Services
Pre-Clinical Development services include: o Pre-formulation, Excipient and Formulation Studies of parenteral, oral, ocular, topical and lyophilized formulations Solubility, pH, Degradation, Potency, Thermal Analysis Vehicle delivery studies for poorly water soluble APIs (e.g.: emulsions or suspension) o Process Development Lyophilization cycle development/optimization Particle/droplet size reduction Technology Transfer Analytical Method Development o Method transfer o Optimization o Qualification o Validation o Examples include: UHPLC, HPLC, UV-Vis, CE, etc.
GMP Testing Services
GMP Testing services include: o ICH Thermal Stability Test Programs o Compendial Testing o Raw material testing for manufacturing use o Release and CoA generation o Trials for Solubility, pH, Degradation, Potency, Purity, Reconstitution o Testing of cytotoxic compounds o Thermal Cycling and Excursion Testing o Materials Compatibility Testing (e.g.: infusion sets, IV bags, stoppers, etc.) o Packaging and container component physical inspections
BioConvergence LLC is audited to, and compliant with cGMP and ISO requirements as a service provider to the pharmaceutical, animal health and medical device industries. Founded in 2006, the company is a woman-owned business operating in a 72,000 square foot facility in Bloomington, Indiana, within 90 minutes of both FedEx and UPS hubs. The company’s service lines include supply chain operations, drug formulation development, analytical methods development and testing activities, and labeling and kitting operations.
•
Contact us to discuss requirements: 812.961.1700
•
Website: www.bioc.us
BioConvergence LLC 4320 West Zenith Drive, Bloomington, IN 47404 BSLO-LSO216
•
Pre-Clinical Development services include: o Pre-formulation, Excipient and Formulation Studies of parenteral, oral, ocular, topical and lyophilized formulations Solubility, pH, Degradation, Potency, Thermal Analysis Vehicle delivery studies for poorly water soluble APIs (e.g.: emulsions or suspension) o Process Development Lyophilization cycle development/optimization Particle/droplet size reduction Technology Transfer Analytical Method Development o Method transfer o Optimization o Qualification o Validation o Examples include: UHPLC, HPLC, UV-Vis, CE, etc.
GMP Testing Services
GMP Testing services include: o ICH Thermal Stability Test Programs o Compendial Testing o Raw material testing for manufacturing use o Release and CoA generation o Trials for Solubility, pH, Degradation, Potency, Purity, Reconstitution o Testing of cytotoxic compounds o Thermal Cycling and Excursion Testing o Materials Compatibility Testing (e.g.: infusion sets, IV bags, stoppers, etc.) o Packaging and container component physical inspections
BioConvergence LLC is audited to, and compliant with cGMP and ISO requirements as a service provider to the pharmaceutical, animal health and medical device industries. Founded in 2006, the company is a woman-owned business operating in a 72,000 square foot facility in Bloomington, Indiana, within 90 minutes of both FedEx and UPS hubs. The company’s service lines include supply chain operations, drug formulation development, analytical methods development and testing activities, and labeling and kitting operations.
•
Contact us to discuss requirements: 812.961.1700
•
Website: www.bioc.us
BioConvergence LLC 4320 West Zenith Drive, Bloomington, IN 47404 BSLO-LSO216
•
