The establishment of the Scientific Advisory Committee, as an outcome of the Bologna declaration on Good Cell & Tissue Culture Practice 2.0 (GCCP 2.0), is a significant step forward. This team develops the organization’s activities while driving the direction of collaboration.

Why GCCP 2.0?

The need for quality control in in vitro cell culture has never been more apparent. With advancements in techniques, cell culture has been increasingly utilized in diverse areas such as toxicology, drug development, and disease studies. However, quality issues, including cross-contamination and microbial infection, pose serious threats to the quality of research and products.

Our vision with GCCP 2.0 is to establish, promote, and educate on good cell culture practices in the in vitro biology field.

Join the GCCP 2.0 Scientific Advisory Committee

If you are a bona fide cell culture practitioner and interested in joining our initiative, feel free to apply! Join us today by sending an email to caat@jhu.edu.

Updates and Developments

Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0) offers a comprehensive framework underpinning our ethos. These guidelines reflect our commitment to promoting the principles required to assure the reproducibility and quality of in vitro (cell-based) assays. The draft, authored by a team of experts, is a testament to our endeavors to enhance the quality and credibility of in vitro work. Explore the Guidelines.

In the summer of 2019, CAAT officially began creating a framework for alternative methods for developmental immunotoxicity testing. This was marked by the formation of the International Working Group focused on the topic of Alternatives to in vivo Developmental Immunotoxicity Testing.

Why are Alternatives Needed?

Non-animal New Approach Methods (NAMs) have been widely recognized as urgently needed in toxicity testing. The necessity for alternative/non-animal test methods concerns, among other things: ethical animal welfare considerations; evaluation of more chemicals across a broader range of potential biological effects; and assessment of more chemicals in a shorter time frame with fewer resources, with the ultimate goal of an equal or greater level of human health protection.

Current testing methods for Developmental Immunotoxicity (DIT) mainly rely on whole animal studies. There is a significant need for sensitive in vitro assays translatable across species. These assays can aid the development of OECD guidelines, among other benefits.

Challenges and the Way Forward

The International Working Group at CAAT has identified the need to address various factors, including:

Key molecular and biological events in developmental immunology relevant to DIT testing
Context-specific needs for in vivo and in vitro DIT testing strategies
Identification of DIT reference chemical candidates
Assessment of the usefulness and appropriateness of existing in vitro strategies
Identification of gaps in existing testing schemes that can be filled by novel in vitro DIT assays or testing strategies
Feasibility evaluation of in vitro DIT testing strategies to reduce/replace in vivo DIT strategies

Working Group: Our Mission

The International Working Group’s mission is to identify gaps in alternative DIT. They also aim to establish a framework to foster the refinement and development of new alternative test methods suitable for screening of DIT compounds. The group comprises stakeholders from regulatory agencies, NGOs, academia, and industry.

Steering Committee
Fenna C. M. Sillé, PhD
Helena Hogberg, PhD

Working Group Participants
Representatives from Academia, Government, and Industry & End-Users.

Academia
Johanna Gostner, PhD (Biocenter, Medical University of Innsbruck)
Emanuela Corsini, PhD (University of Milan)
Robert Wright (Librarian III, John Hopkins, SOM Admin Welch Informationist Services)

Government
Dori R. Germolec, PhD (NTP/NIEHS)
Suzanne Fitzpatrick, PhD, DABT (FDA)
Cameron Bowes, PhD (Health Canada)
David Lefebvre, PhD (Health Canada)
Shifawn O’hara, PhD (Health Canada)

Industry & End-user
Vic Johnson, PhD (BRT Labs)
Leigh Ann Burns-Naas, PhD, DABT, ERT, ATS (Magnolia Toxicology Consulting, LLC)
Mark Collinge, PhD (Pfizer)

In June 2007, the National Academy of Science (NAS) unveiled a visionary report: Toxicity Testing and Assessment in the Twenty-first Century: A Vision and a Strategy. This document heralded a major transformation in regulatory toxicity testing that mirrors CAAT’s principles. The report advocated a shift from traditional whole-animal-based testing to methods predominantly based on in vitro techniques, human cell cultures, in silico biokinetic modeling, and mechanisms of toxicity understood through systems biology.

In essence, the NAS report served as a roadmap for the future, marking a departure from the existing testing paradigm. It endorsed the use of high-throughput, in vitro methods and in silico modeling techniques focused more on human biology than on animal models.

Collaboration and Commitment: The MOU

On February 14, 2008, the Environmental Protection Agency (EPA), the National Toxicity Program (NTP), and the National Institutes of Health (NIH) signed a memorandum of understanding (MOU). The MOU aimed to develop and implement new high-throughput, in vitro methods for testing chemicals and drugs, reflecting both the best and most humane science. Based on the recommendations of the NAS report, the MOU paved the way for comprehensive data collection. This MOU marked a shift toward US development of alternative methodologies.

t4 Achievements: Insights and Reports

Our ongoing t4 initiatives and published reports further our commitment to the advancement of alternative toxicity testing methods:

 t⁴ Workshop Report: Nanotoxicology: The End of the Beginning ­ Signs on
the Roadmap to a Strategy for Assuring the Safe Application and Use of
Nanomaterials (ALTEX)

An expert consortium review of the EC-commissioned report ³Alternative
(Non-Animal) Methods for Cosmetics Testing: Current Status and Future
Prospects ­ 2010²