BioRelianceCell Banking and Storage

Cell bank development, characterization, and storage you can count onTo ensure the safety of biopharmaceutical products produced in living cells, global regulatory

agencies require that cells used in the manufacture of these products be banked and

characterized according to the highest possible standards. Who you choose to perform

these tasks is critical to your ability to meet downstream development and manufacturing

schedules, ultimately leading to the success or failure of your future goals. BioReliance’s cell

banking services offer the confidence, convenience, and availability your time-sensitive, unique

bioproduction projects require. We have extensive experience banking mammalian and insect

cells. From preliminary testing of seed stocks to preparing and qualifying cGMP Master and

Working Cell Banks, to secure long term storage, BioReliance can meet your needs.

Comprehensive service, confident resultsOur scientists are experts in cGMP cell bank production, and cell line characterization. Biosafety

testing and characterization methods include sterility and mycoplasma testing, isoenzyme

analysis, in vitro and in vivo assays for adventitious viral contaminants, reverse transcription

assays, antibody production assays, transmission electron microscopy, PCR and qPCR assays,

bovine and porcine virus assays, and retroviral infectivity assays. A complete cell banking

service, including pre- and post-bank testing, is generally completed in about four months

(Figure 1, below).

Secure cell storagecGMP, continuously monitored facilities in US and UK for true bi-continental security. Vapor

phase liquid nitrogen and –80º C freezers offer complete flexibility and protection. Each bank

is certified free from mycoplasma and tested for sterility prior to storage and then divided and

stored in separate validated freezers.

Proven systems – Cell banking since the early 1980s, with testing of over 1,000 banks

Cell bank experience – Mammalian and insect cell lines

Full service – Includes cell expansion, testing, and long-term storage

Global cGMP facilities – Meet worldwide regulations, facilities in the US and Europe

Bi-continental cell storage – Secure storage of eukaryotic, prokaryotic and viral biological materials

Figure 1. Timeline for a complete cell banking service.

Preliminary testing of seed stockMycoplasma and sterility testing performed on expanded vial of cells(approx. 4 weeks)

Evaluation studyRecommended (approx. 3 weeks)

cGMP production of Master Cell Bank or Working Cell Bank(approx. 4 weeks)

Characterization of Master Cell Bank or Working Cell Bank(approx. 6 weeks)

Cell Bank storageBiorepository facility provides secure long-term storage

www.bioreliance.comNorth America Toll Free: 800 553 5372 Tel: 301 738 1000

Europe & International Tel: +44 (0)141 946 9999 • Japan Tel: +81 (0)3 5796 7430Email: info@bioreliance.com

©2012 Sigma-Aldrich Co. LLC. All rights reserved. BioReliance and SAFC are trademarks of Sigma-Aldrich Co. LLC or its Affiliates, registered in the US and other countries. F-0020309

BioRelianceCell Banking and Storage

Global facilities are available to complete your projectsFacilities for cGMP mammalian and insect cell banking are located in Rockville, MD (Figure 2,

below) and Glasgow, UK (Figure 3, below). Each facility has a continuous program for Materials

Management and Control (MMC), QC, and QA support for incoming raw materials testing, in-pro-

cess checks, and pre-/post-cell banking certification of all areas. Our calibration and validation

program, along with constant equipment monitoring, ensures that all equipment is maintained

within specified process tolerances. All equipment and suites undergo routine cleaning to ensure

that your project is taking place in a truly clean environment.

Dedicated project team means no surprisesAs part of our cell banking service, a dedicated project team will be assigned to you, to keep

you informed of your bank’s production and testing progress on a regular basis. In addition to

being available during the project, this knowledgeable team will meet with you in advance to

finalize technical specifications and recommend a compliant testing program.

Custom solutionsWe recognize that every project has its unique characteristics. That’s why we provide every

project with a custom plan of action. To learn more about BioReliance’s cell banking services or

to discuss your project with an experienced representative, contact us at info@bioreliance.com

today.

Rely on us to generate, test, and securely store your Master Cell Banks and Working Cell Banks

Figure 2. Rockville, Maryland cGMP cell banking facility.The cGMP cell banking area consists of ISO 8 (class 100,000) entry and exit airlock, ISO 7 (class 10,000) process and return hallways, and four functionally-independent ISO 7 processing suites. Each suite consists of 225 ft2 of operating space with terminally HEPA-filtered, 70% recirculated air under positive pressure from a dedicated air handler. All projects are antibiotic-free and handled in ISO 5 (class 100) laminar flow hoods with both static and dynamic environmental monitoring. Operator activities can be viewed from the outside by customers via telescoping cameras which zoom up to 32X and allow for documentation to be read from the monitor.

CLEAN ROOM C

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CLEAN ROOM D

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CLEAN ROOM E

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PROCESS CORRIDOR

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STORAGE

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CORRIDOR

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LOCKERS

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STAGING

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GOWN-OUT

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RETURN CORRIDOR115b

ISO 7/Class 10,000 ISO 8/Class 100,000 Unclassi�ed

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Figure 3. Glasgow, UK cGMP cell banking facility.The cGMP cell banking area consists of grade B rooms dedicated to a single client (P01, P03, P05, P07). P02, P04, P06 and P08 are rooms available for cell banking on a campaign basis. P04 and P08 are Grade B rooms; and P02 and P06 are Grade C rooms.