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Biomanufacturing Support Services

Welcome to the homepage for Biomanufacturing Support Services.

 

Biomanufacturing Support Services encompasses all of the support assays and technologies required for therapeutic production. At BioReliance, we specialize in biomanufacturing and provide the highest quality therapeutics. Our cGMP compliant production facilities and extensive regulatory experience provide support for product development and regulatory approval.

 

Biomanufacturing Support Services at BioReliance consists of Process Development, Biorepository, Analytical Services, Clearance Services, and Biologics Safety Testing.

 

1. Process Development (Biomanufacturing)

Process Development for therapeutic production consists of optimization, scale-up, and purification. The goal of process development is the manufacturing of a reliable, reproducible, therapeutic product made in the desired quantity. At BioReliance, we specialize in process development and provide the highest quality therapeutics. Process development services at BioReliance is composed of:

  • Serum-Free Adaptation
  • Virus Production
  • Downstream Purification

 

We offer extensive experience in Process Development supporting the biomanufacturing industry. For more detailed information see our Process Development page.

 

2. Biorepository

A biorepository (biobank) maintains biological specimens in support of a clinical research project. BioRelaince specializes in secure storage of multiple cell types and viral products. Our services are comprehensive and include “Collection and Tracking”, “Storage and Monitoring”, and “Distribution”.

 

BioReliance offers cGMP compliant short term and long term storage under multiple storage temperatures with continuous alarm monitoring of all systems. We maintain biorepositories for a large number of successful therapeutic projects.

For more detailed information see our BioRepository page.

 

 3. Analytical Services

Analytical Services at BioReliance includes the testing of biologic products for purity and identity. We use a variety of state-of-the-art techniques to determine the physical and chemical composition of a therapeutic product. BioReliance looks for predefined criteria related to safety, stability, and efficacy in the final product formulation.

 

For more detailed information see our Analytical Services Biomanufacturing Support page.

 

4. Clearance Services

Manufacturers of therapeutic products are required to assess the ability of the biomanufacturing process to produce a product that is safe for use in humans.

 

BioReliance has conducted thousands of Clearance studies for clients around the world. Our experience allows us to advise our clients on the most appropriate, custom process steps for clearance and to satisfy regulations. Clearance Services at BioReliance covers:

  • Viral Clearance and Viral Safety
  • Cleaning Validation/ Sterilization Validation
  • Prion Detection (TSE Clearance)
  • Column Re-Use

 

For more detailed information see our Clearance Services Biomanufacturing Support page.

 

 

5. Biologics Safety Testing

 

Safety testing is a critical component to every step of the therapeutic biomanufacturing process. From upstream production to downstream processing, the correct safety procedures maintains therapeutic integrity and ensures a product that is safe to use in humans. Biologics safety testing at BioReliance includes an enormous array of assays:

 

  • Cell and Virus Characterization
  • Raw Materials Testing
  • Bulk Lot Release Testing
  • Final Product Release Testing
  • Genomic Services
  • Biodistribution Services
  • Cross Reactivity Services

 

For more detailed information, see our Biologics Safety Testing page.