1) What are the unique features of GenScript ProBio as a CDMO? Could you please introduce GenScript ProBio to Medicon Valley?
GenScript ProBio is a subsidiary of GenScript Biotech Corporation that offers CDMO services, spanning from drug discovery to commercialization. Our proactive strategies, professional solutions, and efficient processes are focused on cell and gene therapy (CGT), vaccine development, and antibody protein drugs, all aimed at accelerating drug development for our customers. We have established companies in the United States, the Netherlands, South Korea, and China and other regions to serve global customers, and have helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 50 IND approvals since October 2017.
For CGT, our end-to-end solution covers plasmid and virus CMC for IND filing, as well as clinical and commercial manufacturing. In the field of biologics discovery and development, we offer innovative solutions including therapeutic antibody discovery, antibody engineering, and antibody characterization.
In our biologics CDMO services, we have established a DNA to GMP material platform, encompassing stable cell line development, host cell commercial licensing, process development, analytical development, and clinical & commercial manufacturing. We provide both fed-batch and perfusion processes to meet the increasing demands for antibody and protein drugs.
2) What’s the crucial considerations in choosing the right CDMO for a therapeutic drug development project？
To us there are three considerations in selecting the right CDMO:
Firstly, expertise in specific therapy area. Selecting a CDMO with demonstrated expertise in your target therapy area is paramount. Working with a partner experienced in the processes unique to your drug modality will increase its chances of success. For example, if your project involves a new bispecific antibody (bsAb), partnering with a CDMO with a proven track record in bsAb production can expedite the development process and facilitate regulatory approval.
Secondly, experience and track record in specific manufacturing process. Assessing the CDMO’s experience and track record in the exact manufacturing process used in your drug development project is crucial. For instance, a project requiring single-use bioreactors will benefit from working with a CDMO with strong experience in this process. The CDMO’s access to state-of-the-art equipment and infrastructure, as well as knowledge in handling any challenges that may arise, ensures delivering high-quality products with minimal delays.
Thirdly, flexibility and adaptability to project timelines and requirements.It is vital to assess a CDMO’s ability to adapt to your project’s unique timelines and requirements. Reviewing their history of quickly executing scalable pilot projects or accommodating sudden regulatory changes will give you confidence in their ability to maintain momentum and reduce the risk of project delays.
By carefully evaluating these factors, drug developers can confidently choose a CDMO partner that aligns with their goals, provides the necessary expertise and support, and helps mitigate risks associated with the drug development process. Ultimately, a strong partnership with a CDMO can lead to accelerated timelines, improved production efficiency, and successful commercialization of innovative biologic drugs to treat a variety of diseases.
3) How do you expect to contribute to Medicon Valley Alliance?
Medicon Valley region is an exciting region with a fast-growing life science sector. Driven by our mission of “Innovation through Collaboration,” GenScript ProBio is dedicated to assisting customers in shortening the timeline for the development of biological drugs from discovery to commercialization, while significantly reducing R&D costs.
Choosing the right CDMO is a critical decision that can either propel your drug development project forward or hamper its success. GenScript ProBio can provide several benefits to other members of MV. I would like to highlight four elements.
Rich experience: GenScript ProBio has been gradually expanding its antibody discovery capabilities and establishing process development capabilities since 2004. With nearly 20 years of experience, we have developed robust expertise in the field of CGT, vaccine and antibody protein drug.
Regulatory Compliance: we help navigate the complex regulatory landscape, ensuring adherence to standards and successful submissions. Our manufacturing facilities adhere to the regulatory requirements of the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medical Products Administration (NMPA).
Scalability: Experience and expertise in scaling up and optimizing manufacturing processes ensure meeting increased drug demands and promising therapeutic outcomes.
Quality: GenScript ProBio has implemented a system for Phase Appropriate Compliance. Depending on the stage of a project, different levels of quality oversight are applied. In addition, we have established a Customer Quality Verification project management platform to provide customers with the highest quality efficiency.
By becoming a member of MVA, we gain the chance to actively engage in a diverse range of pertinent meetings and workshops, ensuring our comprehensive understanding of the operational landscape in which our customers thrive. Our ultimate goal is to shape a healthier future.