Seminar Programme
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Drug Formulation Development Seminar

Drug Formulation Development Seminar

Venue: Seminar Room 4C (East Hall 4)
Capacity: 150 Seats ※Pre Registration required
April 18(Thu.)
April 18(Thu.)
Consecutive interpretation

Regulatory Considerations in Drug Formulation


Azedine Barik, PhD

CEO & Principal Consultant

CMC & Regulatory Affairs

PMP Consulting Co., Ltd.

This seminar will cover the regulatory aspect of drug formulation, including compliance with ICH guidelines for drug product impurities and specifications. Controlling impurities in the finished drug product is a crucial issue in drug formulation. It requires not only a clear understanding of the various types and sources of impurities, but also robust regulatory strategies to ensure compliance with regulatory requirements. The same applies to the drug product quality characteristics covered by the specifications, which are chosen to confirm the quality of the drug product and ensure its safety and efficacy.


April 18(Thu.)

Pharmaceutical Formulation Design using Digital Technologies


Mr. Hiromi Baba

Group Manager

Digital Translational Research Group, Translational Research Department

Maruho Co., Ltd.

For the development of pharmaceutical products, the formulation design ensuring spatiotemporal delivery of active pharmaceutical ingredients (APIs) as well as the discovery of APIs are required. However, pharmaceutical formulation has generally a vast design space; thus, optimizing the formulation requires extensive trial and error, which is laborious and expensive in the pharmaceutical industry. We use two representative digital technologies—informatics and molecular simulations—to streamline formulation developments. In the presentation, I will introduce the details of the constructed prediction models using digital technologies which can be used to evaluate even virtually generated formulations and their applications in formulation design.


April 18(Thu.)

What’s next in ATMP manufacturing?


Mr. Marco Laackmann

Sales Director

Pharmaceutical Technologies

Harro Höfliger Verpackungsmaschinen GmbH

The open, manual processes that drive cutting-edge research in the ATMP lab do not translate easily to the commercial manufacturing environment. They are too costly, vulnerable to contamination risks, reliant on unscalable labor models—and they aren’t GMP compliant. The presentation will discuss the way forward to closed and automated equipment solutions to facilitate new modalities. New manufacturing technologies are designed to support the complex ATMP product pipeline to establish safe cell and gene manufacturing models at commercial scale. Discussed technologies are:

-Happy Cell Factory: new approach for commercial cGMP manufacturing of Cell & Gene Therapies

-Leon Nanodrugs: non-viral vector manufacturing and nano-encapsulation in closed sterile system ready to fill

-baXeptic: from lab to production in aseptic IV bag fill and finish

-Aseptic Solids: new technologies for aseptic solids to enable product stability beyond lyophilization


April 18(Thu.)

Global extrapolation of Japanese Reliability Standards.


Shinsaku Naito, Ph.D.

Consultant in pharmaceutical development

Former Otsuka Pharmaceutical Factory, Inc.

The Japanese Reliability Standard, which are completed after QC followed by QA, is fundamental to drug discovery research and is a fundamental promise that we should observe even if the test conditions, such as exploratory studies and foreign studies, are different. Given that drug discovery is fundamental to contributing to global healthcare, it is important to utilize trial data globally. In this Lecture, by understanding the reliability criteria, we believe that the global standards should be met with respect to compliance or extrapolation to the reliability criteria. By doing so, we hope to make efficient drug discovery that contributes to healthcare.


April 18(Thu.)

RNA drug development with advanced lipid nanoparticle technologies


Mr. Tomohiro Asai


Department of Medical Biochemistry 

School of Pharmaceutical Sciences

University of Shizuoka

Advances in lipid nanoparticle (LNP) and RNA technologies have led to the approval of the world's first mRNA vaccine against COVID-19. The efficacy and safety of mRNA as a therapeutic modality can be further enhanced by improving LNP technology. In order to expand the possibilities of mRNA-based drug discovery, we are focusing on improving LNP technology using our original pH-responsive lipids. In this talk, we will introduce the characteristics, effectiveness, superiority of our mRNA/LNP formulation, and our efforts for practical implementation.



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