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:
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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
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 | ✓ | ✓ | ✓ |
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 | ✓ | ✓ |
Facility monitoring system: temperature and relative humidity | ✓ | ✓ | |
Filling | Tamper evident, fill tolerance, and semiautomated packaging | ✓ | ✓ |
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 | ✓ | ✓ | ✓ |
Facility monitoring system: temperature and relative humidity | ✓ | ✓ | ✓ | |
Filling | Tamper evident, fill tolerance, and semiautomated packaging | ✓ | ✓ | ✓ |
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
Bioprocessing resources
Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing: