BioConvergence LLC
4320 West Zenith Drive
Bloomington, Indiana 47404-7401
Phone (812) 961-1700
Fax (812) 961-1733
info@bioc.us
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CORPORATE MISSION
BioConvergence LLC is an experienced contract service provider offering cGLP parenteral product development, cGMP materials management including cold chain storage, and consulting services to the biotechnology and pharmaceutical industries.
KEY PERSONNEL
Alisa K. Wright, Chief Executive Officer
Lance Wright, Chief Engineering Officer
John Brooks, Chief Operations Officer
Jeff Schwegman, Ph.D., Chief Scientific Officer
Steve Bryant, Business Development & Marketing Manager
COMPANY HISTORY
BioConvergence is a women-owned business with over 150 years of experience in pharmaceuticals and is dedicated to providing best-in-class outsourcing services to the biotechnology and pharmaceutical industries. The company was established in 2004 and our headquarters located in Bloomington, Indiana where our new 50,000-square-foot facility houses a state-of-the-art 30,000-square-foot cGMP warehouse and 2,500-square-foot cGLP laboratory that is designed for the needs of our clients. We have 21 employees.
CORPORATE HIGHLIGHTS
2004 – Company established
2005 – First client project (drug development)
2006 – 50,000 square foot facility completed and validated
2006 – FDA audit performed with ZERO 483 observations
SPECIALTIES
- Parenteral Product Development (lyophilized formulations, solutions, suspensions, and emulsions for both small and large molecules; formulating and processing molecules that are unstable in solution)
- cGMP Materials Management (services for API, intermediates, raw materials, packaging components, delivery devices and product – during development, clinical and commercial phases; validated environmental chambers range from -80ºC to 25º C for storage at frozen, refrigerated and controlled room temperature conditions; validated 21 CFR Part 11 compliant ERP system which tracks inventory transactions and temperature monitoring)
- Consulting Services (clients utilize our experienced quality auditors with experience in conducting regulatory inspections by the FDA, EMEA, MHRA and Health Canada)
- Our e-transparency solution, which is the first of its kind, provides clients real-time secure access to their data found in our research scientists’ laboratory notebooks, ERP material transactions and SOPs. We utilize our electronic laboratory notebook (ELN) system and enterprise resource planning (ERP) system to allow our clients real time access to their information and data
KEY PRODUCTS AND SERVICES
Parenteral Product Development
- Pre-formulation and formulation development
- Process development
- Analytical method development and validation
- Lyophilization cycle development and optimization
- Stability storage and testing
- Pre-clinical and toxicology batch manufacture
- Technology transfer support to clinical and commercial manufacturing sites
- Counterfeit drug detection
cGMP Materials Management
- Sampling, dispensing, component inspection, packaging, monitoring, global shipping
Consulting Resources
- Engineering, validation, operations, quality
