BioQuest will provide guidance and develop procedures to execute, control and monitor production processes that are validated to ensure that the processes consistently produce product conforming to specifications.

• Facilitate scale-up as manufacturing requirements increase
  
  

• Simplify operations by streamlining up and downstream processes
  
  

• Develop organized processes that facilitate validation procedures

We can help you in all the following areas:

• Design Control Implementation
• Process Development
• OEM Relationships
• Project Plan Development
• Scope and Time Management
• Cost and Human Resource Management
• Risk Management
• Clean Room Operations
• Quality Systems Documentation Programs
• Validation Engineering Programs
• Validation Master Plan Development
• Equipment Installation Qualification (I/Q)
• Equipment Operation Qualification (OQ)
• Equipment Performance Qualification (PQ)
• Process Validation (PV)
• Test Method Validation (TMV)
• Sterile and Aseptic Production Processes
• BL3 Level Barrier Controlled Production

Manufacturing Process Development
BioQuest process team members are experienced process development scientists. Their efforts have been responsible for international technology transfers, and FDA compliant process development and validation activities for many Fortune 500 Pharmaceutical, Diagnostics and Medical Device manufacturers.

BioQuest possesses extensive expertise in formulation areas for:  liquids, ointments, lotions, dry tabletting, formulations for lyophilized products in   environmentally controlled (clean, aseptic, 10,000, 1,000 and 100) environments.

Production Process Development
The objective for process development activities is to design and implement production processes with zero deficiency ratings. BioQuest¯s process team members have successfully achieved this milestone through efficient design, systematic process validation and documentation control.

BioQuest has facilitated business growth and provided effective means by which to develop, acquire, integrate, and transfer system requirements from Technology, Development, and Manufacturing Centers to meet customer needs. This has included the development and GMP/ISO900 compliant management of a BL2-LS fermentation facilities, diagnostic kit production facilities as well as, development, improvement and transfer of processes (including fermentation scale up, purification of antibody and conjugate products, improvement of reagent stability, clean, aseptic and sterile processing) to manufacturing / production.

BioQuest Process Capabilities Profile

• Development and Validation of Quality Assurance Test Methods
• Design and completion of test Installation and Operational Qualifications
• Development of organization devoted to manufacturing processes and new products
• Management of installation of equipment for product formulation and filling requiring unique environmental tolerances
• Formulation scale-up design
• Lyophilization cycle development
• Management of company's Process Validation System
• Development of process capacity growth plans for product lines
• Process transfers to manufacturing