Setting the Precedent for Artificial Intelligence and Full Laboratory Automation

CMIC Group, the first and largest CRO in Japan with extended services in drug development and GMP manufacturing in the US, Japan and Asia, held a webinar Advanced ODT Technologies for Drug Development in Japan and the US on April 11, 2019.Since its introduction in the 1980s, the market of orally disintegrating tablet (ODT) has grown annually and ODTs are now available in a variety of therapeutic areas, both over-the-counter (OTC) and by prescription. ODT market is projected to reach US$21B in 2023.In this webinar, CMIC and Aprecia experts talked about advanced ODT technologies and its advantages in drug development.

While therapeutic monoclonal antibodies (mAbs) have been on the market for over 25 years, it wasn’t until recently that the production of these essential biologics began to move away from traditional methods toward advanced bioproduction techniques like continuous processing.

There is more to Biopreservation than storage on ice or freezing at a rate of -1°C/min. To comprehend the rationale behind Biopreservation Best Practices, a basic understanding of cellular response to cold and freezing is essential. This presentation will identify the critical process parameters (CPPs) of Cold Chain, such as freezing and thawing rates, storage and post-thaw stability, and container type, among others, and will discuss the impact of these CPPs on critical quality attributes (CQAs) such as viability, yield, proliferation rate, and return to function.

Biotherapeutics are a class of large medicinal products that are being increasingly used for various medical applications including vaccination, therapeutic drug delivery systems and the treatment of human diseases. Biotherapeutics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, they can inappropriately activate the immune system. This potential biotherapeutics-mediated immunogenicity must be assessed as early as possible during drug development since it can be the cause of serious events such as autoimmunity, inflammation, anti-drug antibodies (ADAs) production, hypersensitivity reactions (allergenicity) or cytokine storm syndrome. Moreover, since biotherapeutics are produced using biological means, the development of biosimilars must include comparative immunogenicity and biological assay testings.