BioReliance produces cGMP-compliant material for clients developing biopharmaceutical products worldwide. Our scientific knowledge and operational expertise in the transfer, scale-up and qualification of cGMP processes are globally recognized. We provide a dedicated 14,000 ft2 facility that focuses on the fermentation of microbial systems and our comprehensive services include:

Active Pharmaceutical Ingredients production
Cell Banking services
Quality Control
Quality Assurance

API Production

BioReliance specializes in the cGMP manufacture of Active Pharmaceutical Ingredients (API´s) expressed in microbial systems. We have the capability to produce recombinant material at clinical and commercial scale in lots up to 1,000 L. In addition, we have a chromatography suite (class 10,000) and a Class 100 / 1,000 filling suite maintained for bulk product filling. Our fermentation suite for recombinant and non-recombinant bacteria and yeast (single pass flow through HVAC) consist of fermenters with working volumes of 10 L, 100 L and 1,000 L). This suite has the capability for the development and optimization of batch and fed-batch processes as well as product recovery capabilities including:

• Cell disruption
• High pressure homogenizer
• Continuous centrifugation
• Protein refolding and renaturation
• Micro- / Ultrafiltration
• Membrane filtration

Cell Banking

The facility houses state-of-the-art laboratories for Microbial Cell Bank Production, characterization and storage according to the FDA and ICH requirements.

Quality Control

Our Quality Control (QC) group supports production activities, ensuring that all facilities, equipment and critical materials are monitored and cGMP-compliant. The QC group is responsible for:

• Testing and release of raw materials to the manufacturing group
• In-process sample testing during the manufacturing process
• Environmental monitoring of the production suites during and between manufacturing campaigns
• Release testing of the Active Pharmaceutical Ingredient
• Qualified person according to the EU Directive

Quality Assurance

Our Quality Assurance (QA) group assures that manufacturing at BioReliance complies with cGMP requirements. The QA auditors provide inspection, audit and oversight of all production activities including:

• Working with clients and regulatory agencies during audits
• Performing in-process and system inspections
• Reviewing product Certificate of Analysis and Batch Records and approving release of product to client
• Auditing Master Production Records
• Confirming that SOP´s are followed
• Inspecting all cleaning and changeover activities
• Internal GMP training of staff

Back to manufacturing services.