Training

Contribute to understanding and improving skills in biologics products development through attending courses.

This 1-day course provides basic content that can be applied to the development of manufacturing process for biopharmaceuticals and related work. The course is designed for those who have no experience in biopharmaceutical development or manufacturing and for beginners. The course introduces the industry trends and technical background surrounding biopharmaceuticals, as well as the manufacturing process (cellular architecture, cell culture, and purification) for biopharmaceuticals (antibody drug manufacturing processes) which are points to keep in mind.

The development of manufacturing processes for biopharmaceuticals, especially antibody drugs, are outlined from a technical perspective, explaining the scientific principles of each process: construction of antibody-expressing animal cells, building of cell banks, establishment of culture processes, and establishment of purification processes. This 1-day course provides an overview of CMC development for biopharmaceuticals by learning about the production of biopharmaceuticals using animal cells with consideration of manufacturing costs and the basic quality control concepts for producing biopharmaceuticals. In addition, the course provides a bird's eye view of the development of biopharmaceutical manufacturing processes, while also touching on the outline of regulations that need to be taken into consideration.

This 1-day course covers the process of biopharmaceutical production from culture to cell removal, specifically, the construction of expression vectors, serum-free acclimation of production cells, selection of culture media, selection of cell lines and construction of production cell lines, the building of cell banks, setting of culture conditions, scale-up, etc., using teaching materials mainly based on the development of antibody drugs using Chinese hamster ovary (CHO) cells as the host. The lecture covers the development of antibody drugs using CHO cells as a host. Important points in cell line selection, regulations, and points to keep in mind regarding cell bank building/management, the flow of culture process development, development methods, characteristics during culture scale-up, and points to keep in mind during actual production are also explained with specific examples.

This 1-day lecture explains the processes used in the production of biopharmaceuticals, from the removal of production cells to the purification of the target substance and its formulation. Specifically, the lecture outlines typical chromatographic processes used in the purification of antibody drugs. It further expands on the purpose of setting up each process, important points in process development such as scale-up, as well as points to be considered in processes such as virus removal, concentration, buffer exchange, and points to be noted in actual manufacturing, with examples.

In this 1-day course, a new drug development plan for a biopharmaceutical product is formulated around three parts: the clinical part, the non-clinical part, and the CMC part. To achieve this, CMC management with an understanding of the process and pharmaceutical affairs is necessary. In this course, trainees learn the knowledge and skills required for CMC management through lectures and group work.

This 1-day course explains the CMC submission plans for biopharmaceuticals based on recent global biopharmaceutical development strategies and drug regulatory trends. The lecture also explains how to prepare a Common Technical Document-Quality (CTD-Q) and the application of materials based on the Quality by Design (QbD) approach, using actual examples.

This 1-day course introduces notifications, procedures, and points to keep in mind in order to smoothly start clinical trials of gene therapeutic products, transgenic human cell products, and recombinant live vaccines for the prevention of infectious diseases in Japan. The Cartagena Act, which has recently been improved in its operation, is also introduced, as well as the contents that those in charge of development should be aware of.

This 2.5-day course combines theoretical and practical training on how to generate production cell lines, which are the starting point for the development of the manufacturing process for biopharmaceuticals using CHO cells. Providing hands-on experience in basic methods of gene transfer into CHO cells, acquisition of drug-resistant strains, single-cell cloning, cell banking, and other basic operations. The trainees acquire systematic knowledge and skills for the acquisition of stable cell lines with high expression levels.

This 3-day course provides hands-on experience in upstream bioprocessing for production of antibody-based drugs. Using CHO cells, trainees will learn key points about the manufacturing process for biopharmaceuticals while performing a series of process operations from thawing frozen cells to passaging cell cultures in flasks, culture expansion in single-use bags, culture production at the 5L level, and cell removal (harvest). The course is designed to provide trainees with a comprehensive understanding of the manufacturing process for biopharmaceuticals. Moreover, to understand the upstream manufacturing process of biopharmaceuticals, the course provides knowledge on the construction of expression vectors, serum-free cell acclimation, culture media selection, cell line selection, construction of producer cell lines, preparation of cell banks, optimization of culture conditions, scale-up, etc., mainly using CHO cells as hosts for antibody production.

This 3-day course provides hands-on experience in the manufacturing process and downstream processing of antibody drugs, using culture supernatants from which producer cells (CHO cells) have been removed from culture, and purification processes by both affinity column chromatography and cation-exchange column chromatography are applied. Additionally, trainees will acquire systematic knowledge and skills, including key points in actual production, by analyzing target proteins and impurities in purified samples obtained by various analytical methods. The course also explains the process of biopharmaceutical production from the removal of producer cells to the purification of the target substance and its formulation.

This 3-day course provides hands-on experience in the upstream production of manufacturing process for cell-based gene therapy products using adeno-associated virus (AAV), including purification of three types of plasmids for AAV expression, seeding of floating immortalized human embryonic kidney cells (HEK293) and adherent cell derivative of the original HEK293 parent cell line (HEK293T), expression of AAV by triple transfection, collection of AAV from culture supernatants and cells, and measurement of AAV titer in the collection solution. The trainees learn these procedures and main stages of the production process by practicing key protocol steps of including a series of operations from the purification of three types of plasmids for AAV expression, expression of AAV by seeding and triple transfection of floating cells (HEK293) and adherent cells (HEK293T), collection of AAV from culture supernatants and cells, and titer measurement of AAV in the collected solution. In parallel with the practical training, gene therapy and AAV are explained in detail using lecture materials, focusing on AAV production and regulations.

This 3-day course provides hands-on experience with downstream processing of manufacturing process for gene therapy products using adeno-associated virus (AAV). By practicing a series of protocols for the two-step purification of AAV using single domain antibodies (VHH) and anion-exchange chromatography (AEX) of anti-AAV antibodies, measurement of full/empty ratio using analytical AEX column, confirmation of the presence of aggregates using dynamic light scattering, and measurement of titer of AAV using droplet digital polymerase chain reaction. The trainees learn the procedures and key points to remember in the production process. In parallel with the practical training, detailed explanations of gene therapy and AAV are given using lecture materials, focusing on AAV production and regulations.