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Biopharmaceuticals: US locations

Upper Merion

Our Upper Merion, PA facility is cGMP compliant for the manufacture of cell culture and microbial biopharmaceutical bulk drug substances.

The facility provides bioreactor capacity up to the 5,000 litre scale for cell culture and the 10,000 litre scale for microbial fermentation to support all phases of clinical development and commercial production.

 

 

 

Manufacturing capability

Process technology

• Preparation of cell culture and fermentation growth media
• Small and large scale automated cell culture and microbial bioreactors
• Preparation of buffers to support purification
• Flexible purification process options
• Single use equipment options
• Sample lab in each suite equipped with analytical instrumentation

Process equipment

• Stainless steel cell culture bioreactors - 75, 300, 1250, and 5,000 litre scales
• Stainless steel microbial bioreactors – 100, 1000, and 10,000L scales
• Production scale centrifuges
• Depth filtration skids
• Protein purification trains with chromatography columns ranging from 30cm to 2m in diameter
• Ultrafiltration skids
• Nanofiltration for viral clearance

Facility

Classified rooms

• ISO 7 and ISO 8 clean rooms with associated changing rooms
• ISO 5 laminar flow hoods within clean rooms

Utilities and services

• WFI system, PUW system , Clean Steam
• Process gases
• Reverse osmosis/CDI system
• cGMP air handling systems
• Parts washer
• Autoclaves
• Dry chemical dispensing
• Controlled-temperature storage areas, including cell bank storage capabilities
• cGMP warehouse

Manufacturing support

Biopharmaceutical Technology Laboratories

• Development laboratory containing scale-down bioreactors operable at 5 litres to 10 litres
• Full set of accompanying analytical instrumentation
• Highly experienced staff

Quality Control Biochemistry Laboratories

• Biological assays including ELISA and cell-based assays
• HPLC, SDS-PAGE, Peptide Map, Oligosaccharide analysis
• Robotics, qPCR-DNA testing, soloVP, and bioassays
• Assay development and validation
• Product raw material testing
• Raw materials quality management

Quality Control Microbiology Laboratories

• Testing of product and raw materials for environmental contamination (ie. bacteria, mold, endotoxin)
• Certification of clean rooms and production equipment
• Endotoxin and bioburden testing of water for injection, clean steam and in-process materials
• Bioburden testing of purified water and compressed gases
• Environmental monitoring of production areas for airborne contaminants and viable surface contaminants
• Identification of microbial isolates

Supply Chain Planning and Logistics

• Materials management, including cGMP storage
• Fully validated product and sample shipping, including temperature-controlled shipments
• Global supply chain management

Technical Expertise

• Technology Transfer and Project management
• Full engineering capability (maintenance and capital investment projects)
• cGMP cell culture and microbial protein purification scale-up and processing
• Facility validation including computer systems and process validation
• Stability testing and retained samples facility
• Coordination with client to obtain licensing and product registration
• cGMP auditing (internal and supplier)