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BioConvergence

Dec 1, 2006
BioPharm International
Volume 19, Issue 12

Company Description

BioConvergence is a contract service provider offering cGLP parenteral product development, cGMP materials management including cold chain storage, and consulting services to the pharmaceutical industry. 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.

Located in Bloomington, Indiana, BioConvergence is a women-owned business with over 150 years of experience in pharmaceuticals and is dedicated to providing best-in-class outsourcing services. Our scientific expertise and substantial development experience, along with our quality-by-design strategy, contribute to the development of safe, effective, and stable products meeting regulatory requirements.

Biopharmaceutical Techniques Supported

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

Markets Served

BioConvergence partners with biotech and pharmaceutical companies worldwide to create solutions to meet their growing demands for formulation and analytical development. 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.

Products and Services

BioConvergence offers contract services, including: 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; validated environmental chambers range from –80 °C to 25 °C for storage at frozen, refrigerated, and controlled room temperature conditions; validated 21 CFR Part 11 compliant ERP system which tracks all inventory transactions); Consulting Services (clients utilize our experienced quality auditors with experience in conducting regulatory inspections by the FDA, EMEA, MHRA and Health Canada).

Facilities

BioConvergence's new 50,000-sq. ft. facility houses a state-of-the-art 30,000-sq. ft. cGMP warehouse and 2,500-sq. ft. cGLP laboratory that is designed for the needs of our clients. Our lab offers capabilities for lyophilization and other analytical procedures for product development, clinical and commercial phases.