Manufacturing Site Equivalency | Thermo Fisher Scientific

Cell culture media manufacturing facility site equivalencies worldwide Gibco network

Achieve greater assurance of supply

Maintaining your supply of cell culture media is key to securing the continued success of your manufacturing process. For this reason, we have been carefully investing in the growth and capabilities of our manufacturing network, while simultaneously achieving equivalency across these sites to increase supply assurance and support your processes.

We continue to make significant investments to ensure harmonized core manufacturing sites. This means that processes and quality procedures are equivalent at facilities in Grand Island, NY, USA; Miami, FL, USA; and Paisley, Scotland, allowing us to deliver the same quality products from all sites. Site redundancy and harmonization of equipment, processes, and capabilities are a key strategy in risk mitigation, ultimately helping to prevent delays to your biologic manufacturing processes.

Discover some of the ways we achieve equivalency across our sites:

Raw material supply
Milling/blending capabilities
Animal origin-free (AOF) facilities
Batch records and procedures

QA/QC harmonized testing
Blend homogeneity
Packaging
Dispensing processes

Our approach to site equivalency

Our facilities are harmonized across four key areas: raw materials, processes, equipment, and finished product testing. This allows us to produce the same standard of cell culture media at each site. We achieve this through:

Raw materials

Using the same approved supplier inventory specifications and supplier review process at all sites

Process

Mirrored manufacturing steps, validation, and training processes with a focus on a quality systems approach

Equipment

Utilizing the same equipment at all sites, validated to the same standards

Finished product testing

Employment of identical testing methods and equipment, cell lines, and specifications

Explore our equivalency strategies in manufacturing and raw materials

Equivalency in manufacturing

Discover how our sites compare for critical equivalency in dry powder (DPM) and Gibco Advanced Granulation Technology (AGT) format manufacturing:

Grand Island (GI), Miami, and Paisley powder manufacturing

Stage	Process	GI	Miami	Paisley
Dispensing	POMS electronic weigh verification system	✓	✓	✓
	Facility monitoring system: temperature and relative humidity	✓	✓	✓
	Dedicated dust collection (HVAC)	✓	✓	✓
	Qualified ISO 8 (static) annually	✓	✓	✓
Milling	Milling equipment	✓	✓	✓
	Particle size analysis	✓	✓	✓
	Milling rate	200 kg/hr	200 kg/hr	200 kg/hr
Blending	Homogeneity criteria	✓	✓	✓
Blending	Facility monitoring system: temperature and relative humidity	✓	✓	✓
Filling	Tamper evident, fill tolerance, and semiautomated packaging	✓	✓	✓

Grand Island (GI) and Paisley AGT manufacturing

Stage	Process	GI	Paisley
Dispensing	POMS electronic weigh verification system	✓	✓
	Facility monitoring system: temperature and relative humidity	✓	✓
	Dedicated dust collection (HVAC)	✓	✓
	Qualified ISO 8 (static) annually	✓	✓
	0.1% weigh tolerance	✓	✓
Milling	Milling rate	200 kg/hr	200 kg/hr
Blending	Homogeneity criteria	✓	✓
Blending	Facility monitoring system: temperature and relative humidity	✓	✓
Filling	Tamper evident, fill tolerance, and semiautomated packaging	✓	✓

Equivalency in standards for raw materials

The quality of the raw materials used are critical to the quality of your cell culture media which is why we maintain rigorous quality standards for raw materials sourcing across our sites, including meeting animal origin–free and antibiotic-free requirements.

Some of the measures we employ to maintain raw materials quality across Grand Island, Miami, and Paisley include:

Fully harmonized quality testing across the network
Detailed certificates of analysis provided for quality assurance
Ongoing risk management, regularly reevaluated to monitor changes
Raw material audit program
Stringent material requirements
Detailed analytical specifications
Trace element impurity testing

Stage	Process	GI	Miami	Paisley
Dispensing	POMS electronic weigh verification system	✓	✓	✓
	Facility monitoring system: temperature and relative humidity	✓	✓	✓
	Dedicated dust collection (HVAC)	✓	✓	✓
	Qualified ISO 8 (static) annually	✓	✓	✓
Milling	Milling equipment	✓	✓	✓
	Particle size analysis	✓	✓	✓
	Milling rate	200 kg/hr	200 kg/hr	200 kg/hr
Blending	Homogeneity criteria	✓	✓	✓
Blending	Facility monitoring system: temperature and relative humidity	✓	✓	✓
Filling	Tamper evident, fill tolerance, and semiautomated packaging	✓	✓	✓

Decrease media manufacturing risk with Thermo Fisher’s mirrored global facilities

Capacity expansion

In order to maintain your supply continuity support your future processes, we’ve been proactively expanding our manufacturing capabilities and securing our supply chains with a global strategy that will result in more than a two-fold expansion by 2023 including:

Expanded manufacturing capacity for DPM, liquid, and AGT formats
Harmonized manufacturing across our global network and formats
Continued investment in secondary and tertiary sourcing of raw materials
Expanded footprint in Asia