The AAPS published newsletter of December 2011 describes their initiatives regarding advancements in unwanted immunogenicity prediction and understanding risk factors that lead to unwanted immunogenicity, including how they identify partner societies (American Association of Immunologists, European Immunogenicity Platform etc) to share, communicate and expand opportunities to develop Immunogenicity prediction strategies.
In addition, they have conducted a survey on methods being used to predict immunogenicity propensity, including what correlations have been made with clinical data. The questions designed to learn more about how the current industry applies immunogenicity prediction tools and also to estimate interest of members in learning about and advancing this field.
From this survey, IPAPA observed that prediction tools are being widely used, however publicly available data on clinical correlations of prediction methods is still lacking.
Read more at: http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Focus_Groups/TPIFGnewsltrDec2011.pdf
American Association of Pharmaceutical Scientists Therapeutic Protein Immunogenicity Focus Group Newsletter December 2011, Volume 1, Issue 3
Since 1986, a number of therapeutic monoclonal antibodies have been approved by the US FDA and hundreds of therapies are undergoing clinical trials. More importantly, the market for such monoclonal antibodies has grown significantly and their sales growth rate of > 35% far exceeds the <8% sales for small-molecule drugs*.
As an immunogenicity professional you know that technologies for antibody detection and characterisation play a significant role in this process. They can speed up the detection and characterisation processes, simplify the workflow complexity and boost consistent and reproducible results. Click here to read more about innovative ways to boost the development of therapeutic monoclonal antibodies.
For those looking for further mAb’s experitise, you should not miss the 2012 Immunogeniticy. There you will gain insights on technologies and strategies to anticipate, neutralise and tackle risks for immunogenicity.
I look forward to meeting you in Copenhagen on 27th – 28th September 2012.
Beatriz Viellas, Senior Project Manager, Pharma Division
ABSTRACT Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-PCS, review the current state of methods for analysis of protein aggregates. Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics.
Download the article as a PDF file: http://www.datainfoserver.com/eip_review
New article by Satish Kumar Singh, Ph.D, Research Fellow, Pfizer Corporation released in December 2012:
“Impact of product-related factors on immunogenicity”.
In the words of author, “the objective of this review was to provide the product development scientist a critical look at the current state of knowledge connecting CMC aspects and product-related clinical immunogenicity. Relevant cases from the literature are examined in some detail to shed light on often-repeated general statements about the impact of these factors. Because the factors determining immunogenicity are highly interdependent, other factors such as molecule design as well as patient characteristics and disease state are also briefly covered for completeness. The emphasis is on clinical immunogenicity defined as generation of ADAs, although preclinical data are also assessed because often it is the only thing available. The discussion on excipients and container closure also covers their impact on the broader concern about immunogenicity and safety of protein therapeutics mentioned earlier.” (highlighted by Midfield Media)
Link to article: http://onlinelibrary.wiley.com/doi/10.1002/jps.22276/full#jumpTo
The 2012 Immunogenicity will gather global biopharmaceutical, institutes, scientific experts and regulators striving to tackle unwanted immunogenicity which poses threats to patient safety and to scientific development.
The comprehensive program is divided into 2 core areas. The first focuses on Immunogenicity Awareness and Assessment of Clinical Relevance. The second gives practical insights on Detecting, Determining and Mitigating Risks in connection with immunogenicity. These two areas will be linked to assay and immunogenicity strategic questions to ensure you strengthen your risk-balance approach, gain an in-depth understanding of regulatory requirements and, in turn, reach efficacy to your scientific developments.
This is the platform for those active in the immunogenicity field who know that the impact of immunogenicity can be quite severe. If you are in search of expertise, practical know-how and innovative strategies to mitigate immunogenicity risks, join us in Copenhagen in September 2012.
Beatriz Viellas, Senior Project Manager, Pharma Division
Immunogenicity assessment: best practice to increase accuracy and cost-efficiency during pre-clinical and clinical trials
FDA & EMEA Regulatory Approaches: FDA and EMEA Risk Balanced guidance and regulatory matters to ensure continuous compliance.
Assay development plan & methodology: all key issues to improve bioassays efficiency, such as detecting ATAs, validating Assays and use of statistics
Immunogenicity determination, testing and screening: strategies to anticipate risks
Mitigating risks: anticipating, neutralizing and tackling unwanted immunogenicity risks