Upper Merion
GSK Biopharmaceuticals' Upper Merion, PA facility has cGMP compliant streams for the manufacture of mammalian cell-culture derived biologics products, providing bioreactor capacity up to the 5,000L scale to support all phases of clinical development and commercial product launch.

Manufacturing Capability
Process Technology

• Preparation of cell culture growth media
• Small and large scale automated mammalian cell culture bioreactors
• Preparation of buffers to support purification on 5000L scale
• Flexible purification process options
• Sample lab in each suite equipped with analytical instrumentation

Process Equipment

• Stainless steel bioreactors - 75L, 300L, 1250L, and 5,000L scales
• Protein purification trains
• Production-scale affinity chromatography columns
• Ultrafiltration skids
• Microfiltration skids
• Production scale centrifuge

Facility
Clean Rooms

• ISO 7 and ISO 8 clean rooms with associated changing rooms.
• ISO 6 laminar flow hoods within clean rooms.

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

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

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

• 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

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

• Technology Transfer
• Full engineering capability (maintenance and capital investment projects)
• cGMP cell culture and protein purification processing and scale-up
• 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)

Learn more about: Our UK locations

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