The importance of manufacturing biologics is increasing recently. In this presentation, we will introduce the activities of the MAB organization toward gene-therapy vector manufacturing.

It takes long-term and much effort in the process development for manufacturing biopharmaceuticals because of many QC items for screening.

In this seminar, laboratory automations which can reduce the time and manual operations will be introduced. You can get more information if you use high resolution mass spectrometry simultaneously.

In addition, technology for on-line analysis using UPLC connected to process instruments will also be introduced in this seminar.

This talk will cover techniques for the discovery and performance evaluation of antigen-binding peptides and antibodies using mammalian cell display system.

What you develop the robust purification processes by combining some chromatography media effectively has been one of the important key factors to achieve the projects in success at the manufacturing scale for the biotherapeutic drugs.

Recently, the new bio modalities such as mRNA, ADC and so on have been developed and attention has been paid in the market.

In this presentation, we would like to introduce you some case studies including the next generation of biologics and our Bio-Rad’s process chromatography solutions.

Merck and Agilent highlight an initial use case demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.

In recent years, the number of drugs with Prefilled syringe (including autoinjectors) has been increasing in around the world due to factors such as the increasing high concentration of drugs and the increasing need for home medical care because of the aging society.
In addition to introducing market trends, we will also introduce BD's various support services, “One-Stop Services”, which can be utilized by pharmaceutical companies at various stages from the development prefilled syringe drug formulations to their commercial launch.

With the advancement of personalized medicine, the business operations are completely different from those of conventional pharmaceuticals. For regenerative medicines, it is essential to develop a complex supply chain starting from the patient, and digital transformation across stakeholders including medical institutions and wholesalers are important. Key success factors for building these operations are introduced during this session.

Effective Resource Allocation and Progress Management in Pharmaceutical Development: This seminar will delve into the crucial aspects of pharmaceutical project management. It focuses on the strategic placement of resources - people, materials, and finances - to ensure timely decision-making with necessary data. The session aims to elucidate techniques for expedited social implementation of advanced technologies in drug development.

In this seminar, we introduce the LC & LC/MS analysis method for mRNA vaccines and pharmaceuticals in accordance with the revised USP Draft Guidelines, examples of oligonucleotide impurity analysis by 2D-LC, and fractionation purification. We will also introduce the latest information from Agilent’s nucleic acid pharmaceutical CDMO in Colorado.

Finally, we introduce Agilent’s Bio-columns for nucleic acid analysis and present examples of oligonucleotide analysis and fractionation purification.

Protein-based biopharmaceuticals　have become an important field in the treatment of disease. Advances in technology have led to the creation of diversified antibody types and novel therapeutics for various diseases. Cytiva's chromatography resins have been used in the production of many pharmaceuticals, but the resin toolbox needs to be further expanded to meet the various needs in the processes. Cytiva will be presenting the next generation of new affinity chromatography resins and its applications in purification of antibodies and virtually any recombinant proteins.

Year of 2024 is the seventh year since we transitioned to the current management team led by our newly appointed CEO. We have achieved sustained growth over time, while facing challenges as a biotech venture company. Where is the company headed toward the future as a drug discovery biotech? How should we think about efforts to increase R&D productivity in the drug discovery business, which is often considered to be high-risk? I would like to talk about our efforts to create values going forward.

Organocatalysts have attracted much attention as environmentally-benign catalysts, and were awarded 2021 Nobel Prize in Chemistry. In this lecture, process chemistry will be discussed in connection with organocatalysts.  Recently advancement of chiral Brønsted acid catalysts will be also discussed.

In recent years, as drug discovery modalities have diversified along with the progress of science, API process research has played an important role in constructing manufacturing methods that can provide a consistent quality, stable supply, and affordable cost of highly precisely designed compounds.  In this presentation, I would like to introduce examples that we have been working on in our API process research and discuss the issues that need to be addressed in the future.

Although it has be said that sufficient information on polymorph has now been accumulated, we have still difficult issues to overcome. This presentation, I will show late-appearing polymorph, in which even after a thermodynamically stable crystalline form is selected as the drug substance form, a new truly stable crystalline form suddenly appears later. I will also present the case study where it is difficult to discriminate between polymorphs.

Considerable financial investment and long development period are required for the research and development of new drugs; however, approval success rates of drug candidates are decreasing year by year. To develop new drugs faster, process development for drug substances must be strategically carried out. In this lecture, I will introduce the changes in the Astellas Pharma’s process development strategies.

In the synthesis and manufacturing of pharmaceuticals, continuous-flow methods have advantages over conventional batch methods in terms of reduced environmental impact, efficiency, and safety. In this lecture, I will discuss cutting-edge basic research in our laboratories towards continuous-flow synthesis and manufacturing of active pharmaceutical ingredients (APIs). It is worth noting that, unlike batch methods, continuous-flow methods are relatively easy to scale up.

Inhibition of myostatin is attractive as a therapeutic strategy for muscle atrophy including muscle dystrophy and sarcopenia. We have developed the functionalized peptide composed of myostatin-binding peptide and photooxygenation catalyst. The functionalized peptide selectively oxygenates and inactivates myostatin by photooxygenation. The application of this method could provide efficient inhibition of a desired protein by photoirradiation.

The YCU Co-creation Innovation Center leverages Yokohama City University's resources, including talent, research outcomes, and facilities, along with the unique characteristics of Yokohama as a hub of international exchange and a network of medical institutions. Through collaborative efforts with diverse stakeholders in a transparent and close-knit relationship, the center aims to actively utilize these resources. The focus is on creating exciting and innovative solutions for the future, contributing to a vibrant and forward-looking environment. The initiative strives to foster co-creation by tapping into the rich potential of Yokohama and building innovative pathways from Yokohama to the future.

Human iPS cells, invented in 2007 by Professor Shinya Yamanaka, Kyoto University, are expected to be applied to regenerative medicine and drug discovery using disease-specific iPS cells (iPS drug discovery). We developed iPS drug discovery targeting amyotrophic lateral sclerosis (ALS) and discovered Ropinirole hydrochloride as an effective therapeutic candidate. Phase 1/2 trials targeting ALS patients have already been completed, and clinical safety, tolerability, and efficacy have been confirmed. In this lecture, I would like to talk about iPS drug discovery for ALS so far and future developments.

Recently, the development of cellular medicine, in which living cells are applied to the treatment of diseases, has been attracting much attention. Compared to conventional medicines, cellular medicines have been reported to show high therapeutic effect against various diseases, including intractable diseases. On the other hand, the mechanism of action and safety of cellular medicines are still unclear, and the survival period, distribution, and function of cells in the body after transplantation need to be improved. In this presentation, I will summarize the issues in cellular medicine and introduce our research to solve them.

GEXVal is a clinical-stage startup committed to addressing rare diseases. Our primary goal is to deliver cost-effective and innovative treatment options that improve the health and quality of life for patients and their families who live with rare and intractable diseases. With support from patient advocacy groups, our lead program now successfully completed Ph1 studies in Australia, progressing toward addition of another pipeline beyond rare diseases with similar underlying disease mechanisms. We are excited to present our strategy to deliver alternative value uncovered by our unique AI-assisted Repurposing Engine^® and AltVal^® collaboration program, moving towards circular economy in pharmaceutical industry.

The CDMO market is projected to grow 7.29% by 2028. One of the factors is the growth of new modalities. The fragmented CDMO market will continue to become more complex due to differentiation strategies of various companies as new services are offered in response to trends in the pharmaceutical market and new companies enter the market. This presentation will provide an overview of market trends by modality, which will be important for the future of the CDMO industry, and a global overview of CDMO business development and services.

The automation, the new design for manufacturing of antibodies and ADC, and Lotte Biologics strategy will be outlined at this talk.

We have 6 pharmaceutical business sites in Gifu prefecture and conduct contract manufacturing businesses of antibiotics (injectables), biopharmaceuticals including vaccines, and API manufacturing and product development of topical drugs. We are aiming for one-stop contract manufacturing from recombinant protein development to finishing products for biopharmaceuticals. We would like to respond to needs with domestic/overseas partner companies based on our 20 year CDMO experience since our antibiotics business start.

After the covid19 pandemic, all companies are reconsidering their risk management, and as the contract manufacturing of pharmaceutical chemicals continues to return to Japan, we are focusing on expanding our CDMO business for small molecule API. In addition, among the oligonucleotide medicines that are attracting attention as a new modality, we are developing our unique process for long RNA, which is   particularly difficult to manufacture, and we have successfully completed multiple GMP manufacturing operations at our new facility we recently invested in. In this talk, our current CDMO business will be updated in detail.

As Japan's first commercial CDMO for mRNA, Aｒcalis manufactures API and LNP bulk of mRNA vaccine that are scheduled to be launched on the market. In the future, we aim to realize integrated production from template DNA production to final formulation and packaging. At the same time, we are also focusing on drug discovery support and new technology development. We engage in various technical advancement, including mRNA sequence design using AI to improve mRNA stability and translation performance, reduction of double-stranded RNA that causes side reactions, and novel quality evaluation methods for mRNA. In the future, we aim to become a pioneer in a new era as an innovation platformer for mRNA technology, from mRNA drug discovery support to commercial GMP manufacturing.

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.

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.

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

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.

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.

The focus is building Enduring Partnership for Healthcare & Pharmaceuticals between India & Japan. India's commitment to align with Japan's pharmaceutical industry is underscored by its role in saving over 1 trillion USD in the US Healthcare Bill through the supply of quality generics. Addressing challenges such as rising raw material costs and de-risk manufacturing dynamics in China, India offers services in pharmaceuticals, agrochemicals, and chemical manufacturing. With regulatory-approved plants and skilled manpower, India provides a solid foundation for collaborative work, focusing on areas like contract manufacturing and research to enhance mutual growth and innovation.

This seminar will discuss therapeutics of macrocyclic nonstandard peptides pioneered by the presenter and next generation technologies. It will also discuss recent advance in new modality of biologics, “neobiologics”.

mRNA biopharmaceuticals, consisting of thousands of nucleotides, have traditionally relied on biologically-based manufacturing processes. However, innovations in manufacturing through chemical approaches enable enhanced quality control and functionality. In this study, we successfully developed Cap2 type mRNA, previously challenging to produce, using the chemistry-based PureCap method. This method yields mRNA with low immunogenicity and high translational capacity, suggesting new possibilities in the biopharmaceutical field. This presentation will detail the methodology and outcomes of this breakthrough.

Digital biomarkers for collecting disease state data for clinical research and trials

In educational opportunities provided by pharmaceutical companies to medical professionals, we will propose ways to utilize new VR technology, along with examples and evidence from actual medical settings. In today's world, where the successful experience of treatment by patients and healthcare professionals is increasingly important, iVRES supports the promotion of understanding and proper use of medicines.

It is an app equipped with AI functions that focuses on "joints" in order to walk healthily. The evidence-based proprietary algorithm can measure the "quantitative measurement of the range of motion of the hip joint" that has been carried out only at medical institutions until now, and supports the information necessary for walking with a "mutual aid mechanism".

We’re excited to showcase 5 Ukrainian HealthTech companies advancing healthcare through ML and AI, all part of the IT Ukraine Association — an NGO representing 160+ IT businesses and over 90,000 professionals. Our team is committed to promoting growth in the Ukrainian IT sector. We proudly amplify the voices of Ukrainian experts on a global scale, facilitating international experience exchange and collaboration.

1. Viseven: “Connecting digital and non-digital channels using Omnichannel in Japan”

2. WebLab Technology: “AI Agents as Catalysts for Modular Content in Pharma”

3. Drug-card.io: “Future of Pharmacovigilance: The Synergy of AI and Human Expertise”

4. Edvantis: “Machine Learning Opportunities for Medical Affairs Departments to Recognize and Address Drug Adoption Barriers”

5: GlobalLogic: “AI solutions impact in improving quality of care”

Pipon Corporation, a company that handles a large number of contracted development projects for generative AI, will present a case study of the optimal use of generative AI in the pharmaceutical industry.

While home-visit clinical trials that do not rely on visits to medical institutions have the advantage of reducing the burden on subjects, from the perspective of protecting privacy at home, DCT-type clinical trials using medical MaaS are expected to become more widespread in the future. This time, we will introduce the possibility of deploying the medical MaaS "MedaaS" developed by our company and the Toyota Group to DCT vehicles.

We will present about Conversational AI training solutions and real-world examples to help improve business outcomes. 

The focus will be on improving sales skills and manager coaching skills. Through practicing interactions with AI in real-life scenarios, we will discuss how to acquire skills that can be used in the field.

There is still much scepticism about AI drug discovery. SyntheticGestalt, a company at the forefront of AI drug discovery, will present concrete examples of what AI alone can and cannot do. The company will also share how some of its technologies can be used in-house for pharmaceutical companies.

Hedgehog MedTech is focusing on the headache domain, advancing the development of headache AI diagnostic devices, migraine treatment apps, and tension-type headache treatment apps. By covering everything from diagnosis to treatment, we aim to provide a better clinical experience for both patients and doctors. We will continue to develop Software as a Medical Device, focusing primarily on diseases related to women and the working-age population.

Today we are pleased to present four Finnish startups (Monidor Oy, Finnadvance Ltd., Probiont Oy, and Popit Ltd.)– great outcome of high IT technology and medical data system Finland is proud of as a business/investment country. They represent Finnish innovation power supported by well-established industry-government-academia ecosystem, and you will see one of the key elements enabling Finland being ranked as the “happiest country in the world” for six consecutive years.

1: MONIDOR OY “Enhancing Workflow with Remote Monitoring Technology: Monidor - Remote IV Therapy Monitoring for Hospital Wards and Home Healthcare”

2: Finnadvance Ltd. "Accelerating preclinical cancer therapy discoveries with organ-on-chips Probiont Oy: Immunotherapy with confidence"

3: Probiont Oy "Immunotherapy with confidence"

4: Popit Ltd. "At Popit, we're on a mission to revolutionize the medication-taking experience. Our innovative solution, developed in collaboration with healthcare professionals, empowers patients to improve adherence and offers valuable data insights into how individuals are engaging with YOUR medication."

We will introduce how TXP Medical utilizes its RWD and maximizes its unique data characteristics through specific examples.

1. Juntendo University AI Incubation Farm　Opening speech by Juntendo University AI Incubation Farm

2. AI6 K.K.　What is the AiCare platform that improves QoL?

3. InnoJin, Inc.　Development of a virtual reality-based programmed medical device for  the pediatric patients with amblyopia

4. Yuimedi　From Data Standardization to Data Interconnection: Yuimedi's Vision for a Healthcare Data Network

5. K.K. CYBO　Cytology tests revolutionized by DX and AI application

6. APTO, Inc　Challenges and Current Status of AI development in the Medical Industry　How to Collect Data for Medical Use

It is very useful to know effects of medicine or healthy foods in usual life. This seminar presents MIRUWS high precision emotion and CBP estimation using wrist band and data collection method respecting privacy.