Navigation Links
Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes

Harness the Dual Benefits of Freshly Isolated Plateability and the Efficiencies of Cryopreservation

CHICAGO, June 16 /PRNewswire/ -- In today's competitive environment and economic climate, the financial implications of being the first to file a promising new drug compound or chemical entity cannot be underestimated. Researchers and drug manufacturers are under even greater pressure to do more with less, and productivity and cost savings are at a premium. In the race to succeed, fresh hepatocytes (cells that mimic the properties of the liver and are used by researchers to evaluate the metabolism, drug-drug interaction and toxicity of drug candidates in a cost-effective manner) present a number of challenges.

Celsis International plc (LSE: CEL.L) - a leading global provider of innovative life science products and laboratory services to the pharmaceutical, biopharmaceutical and consumer products industries - outlines several key advantages of using cryopreserved plateable hepatocytes over fresh tissue for drug research.

  1. Fewer Restrictions. The limitations of freshly isolated hepatocytes for studies like induction severely restrict the researcher's choices for timing, demographics and retesting. Cryopreservation of these cells permits expanded investigation while retaining clinically significant activity. By removing constraints associated with tissue availability, cryopreservation allows for further testing of activity and genomic characterizations, re-testing from the same donor and scheduling at the researcher's discretion.
  2. Best of Both Worlds. Some cryopreserved hepatocyte preparations retain the fresh hepatocytes' ability to attach to a collagen I coated matrix (cryo-plateable), extending their use for long-term culturing applications like induction. Both human and animal cryopreserved hepatocytes offer other benefits as well. For example, utilizing the entire liver produces larger lot sizes and, in the case of animals, reduces the number and frequency of animals sacrificed. Thus, cryo-plateable hepatocytes present an ideal system by offering the dual benefits of freshly isolated plateability and the efficiencies of cryopreservation.
  3. Reduced Time Delays and Data Variability. As drug manufacturers strive to bring new life-saving drugs to market, time and predictability throughout the R&D process are essential. Even in the early pre-clinical phase, any unpredictability may slow the testing of early investigational compounds by causing scheduling delays that cost the manufacturer lost time and money. In many cases, freshly isolated hepatocytes may not be readily available due to reliance on liver donation which requires staff to remain on call for a liver, and may lead to potential weekend and holiday work. While liver resects from biopsies may improve availability, they are potentially dangerous as they do not include full serology reporting. In contrast, fully characterized cryopreserved hepatocytes can be immediately procured in large inventories and stored at the laboratory, controlling the scheduling of studies and accelerating time to market. Standard induction studies, as an example, typically may be completed 50 percent faster using cryo-plateable hepatocytes.
  4. Improved Efficiency. Cryopreserved hepatocytes may be pre-characterized for enzyme activities, genotypes and for applications like induction or transport, representing another major advantage over fresh products. In fact, cryopreserved products may be obtained to meet specific donor requirements while maintaining high levels of viability, confluence or activity. Large inventories and a minimum five-year shelf-life allow researchers to repeat tests at future dates with no difference in product performance. Likewise, research being conducted at multiple sites can draw from the same product lot for consistent, simultaneous research worldwide.
  5. FDA Equivalency. The use of cryopreserved hepatocytes is recognized as equivalent to using freshly isolated hepatocytes. Acknowledging this trend, the U.S. Food and Drug Administration (FDA) drafted a Guidance for Industry(1) in 2006 advising that cryopreserved tools are a viable and acceptable alternative to fresh research products, especially in metabolism, toxicity and drug-drug interaction testing. Several large pharmaceutical companies have adopted cryopreserved hepatocytes as their primary model for stability, transport and induction studies as evidenced in peer-reviewed literature. As researchers recognize the benefits of cryopreserved hepatocytes for traditional ADME-Tox studies, a broader range of new applications will be realized like high-throughput screening (HTS) and high-content screening (HCS).

In summary, the uncertainties associated with fresh hepatocytes - lack of availability of donors, difficulty matching profiles, unknown enzymatic activities, inability to repeat experiments from the same donor and time restrictions - often mean researchers may unknowingly rely on less-than-ideal donors or resected tissue without serology reporting. With cryopreserved hepatocytes, pharmaceutical manufacturers no longer have to compromise safety, scheduling or productivity. Given their many advantages, the benefits of using cryopreserved suspended and plateable hepatocytes outweigh those of fresh products and should be strongly considered.

For More Information

Visit Celsis' online Cryo Advantage resource center at and download the following poster presentations from Celsis' experts:

  • The Effects of Cryopreservation on P450 Oxidation and Phase II Conjugation Activity
  • A High Throughput Screening Assay for Hepatotoxicity Using Cryopreserved Hepatocytes
  • Comparison of Fresh and Cryo Cynomolgus Monkey Hepatocyte CYP P450 Levels

1 Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling (draft): Guidance for Industry, FDA, September 2006.

About Celsis IVT

Celsis IVT is the premier world provider of specialized in vitro products for the study of metabolism, drug-drug interactions and toxicity in drug discovery and development. Since 1990, pharmaceutical and biotechnology companies have relied on Celsis IVT for quality in vitro products for lead optimization. Celsis delivers faster time to results, enabling more productive and cost-effective research. Celsis IVT's cryo-plateable hepatocytes (the world's largest inventory) and other ADMET research tools are available worldwide. Visit for more information.

About Celsis International plc

Celsis International plc is a leading international provider of innovative life science products and laboratory services to the pharmaceutical and consumer products industries. Each Celsis division delivers substantial time and cost savings to its customers while ensuring product quality and safety for consumers. Celsis' extensive client base includes many of the world's leading pharmaceutical and consumer products companies. The Company is listed on the London Stock Exchange (CEL.L).

SOURCE Celsis International plc
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Celsis Receives Frost & Sullivan 2008 Best Practices Award
2. Celsis Launches RapiScreen(TM) Beverage Microbial Screening System
3. Celsis In Vitro Technologies and Promega to Offer Fast, Reliable Solutions for ADME-Tox Testing With Primary Hepatocytes
4. Celsis Introduces ReACT(TM) RNA-Based Microbial Detection Assays
5. Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
6. Bristol-Myers Squibb Company Outlines Strategy and Productivity Transformation Initiative During Update to Investment Community
7. Vermillion Summarizes Recent Accomplishments and 2007 Financial Results; Outlines 2008 Business Milestones
8. Intervet/Schering-Plough Animal Health Outlines Strength of the Combination
9. Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters
10. Dynamic Outlines Initial Target Markets for Pharmaceutical Cannabinoid Products
11. Avastin Used in Combination with Drugs from Bristol-Myers Squibb Has Advantages in Survival Rates Over the Current Sales-Leading Therapy for Advanced Ovarian Cancer
Post Your Comments:
(Date:10/12/2015)... THOUSAND OAKS, Calif. and BRUSSELS ... and UCB (Euronext Brussels: UCB) today presented additional findings from ... trial. 1 The findings were presented today in an ... Mineral Research (ASBMR) 2015 Annual Meeting in Seattle ... 2 --> The small exploratory sub-study ...
(Date:10/12/2015)... 12, 2015 This report covers the global ... type, products, applications, end-user markets and geographic segmentation. Forecasts ... The global cell expansion market generated revenue of roughly ... revenues of $9.7 billion in 2015 and $22.0 billion ... of 17.8% from 2015 to 2020. This report ...
(Date:10/12/2015)... octubre de 2015 El 8 de octubre, ... récord en el congreso con su declaración acerca del ... Plasma Awareness Week (IPAW), que se celebrará del 11 ... la Plasma Protein Therapeutics Association (PPTA) y ... , Aumentar la concienciación mundial acerca de la donación ...
(Date:10/12/2015)... 12, 2015 LabStyle Innovations Corp. ... Solution, today announced its Medical Director, Dr. Moshe ... MobiHealth,s 5th EAI International Conference on Wireless Mobile ... innovations in mobile and wireless technologies," the conference will ... from October 14 - 16, 2015. The conference is ...
Breaking Biology Technology:
(Date:10/12/2015)... --> --> ... the "Digital Security Control Market by Hardware (Smart Card, ... (Anti-Phishing, Authentication, Network Surveillance, & Others), Service, Application, and ... market is expected to grow at a CAGR of ... Billion by 2020. Browse 65 market data ...
(Date:10/9/2015)... 09 2015 ... the "Samsung Galaxy S6 Fingerprint Sensor ... their offering. --> ) ... "Samsung Galaxy S6 Fingerprint Sensor - Reverse ... --> Research and Markets ( ...
(Date:10/7/2015)... NXTD ) ("NXT-ID" or the ... mobile commerce market and creator of the Wocket® smart ... long- term executive at American Express has been appointed ... ) ("NXT-ID" or the "Company"), a biometric authentication company ... of the Wocket® smart wallet announces Mr. Stanley ...
Breaking Biology News(10 mins):