BioTReC Nucleic Acid Pilot Plant (BNAP)

 

About Us

 

This facility has successfully developed single and bivalent vaccines for various variants of SARS-CoV-2, including the original strains, Alpha, Beta, Delta, Omicron, and Hybrid mRNA vaccines. Preclinical animal studies show significant effects on efficacy and safety validation.

In addition, we are the first to establish a complete assembly and scalable mRNA and mRNA-LNP manufacturing process domestically, along with a quality control analysis platform that meets industrial standard requirements. We adopted the pharmaceutical industry's key concept of manufacturing and processing techniques to make process parameters easily scalable, thereby reducing the technical barriers between R&D and mass production. We successfully completed small-scale mRNA-LNP product manufacturing and developed relevant purification processes. Additionally, we established over 20 QC testing techniques for Drug Substance (DS) and Drug Product (DP) to ensure the high-quality mRNA and mRNA-LNP products.

This facility is dedicated to meeting customer needs by optimizing process key parameters for mRNA drugs of different natures, lengths, and sequences to achieve high yields and reduce by-product formation. Additionally, high-quality mRNA and mRNA-LNP at the research scale are provided to enable more basic research exploration of their clinical applications. On the other hand, comprehensive QA management ensures that production and quality analysis operations run in compliance with GMP principles, meeting regulatory requirements to provide customers with high-quality product manufacturing and analysis services.

 

 

Service Contents

The Nucleic Acid Pilot Facility offers a range of services, including nucleic acid production, lipid nanoparticle encapsulation, and product quality analysis, to support basic research, clinical trials, and product development.

 

 

Production Service

• mRNA Production: Small-scale R&D requirements (< 1 mg specification) and large-scale production (1 ~ 30 mg specification).
• mRNA-LNP Preparation: Utilizing microfluidic technology for the preparation of lipid nanoparticles containing mRNA.
• Customized Production Processes: Adjusting production specifications and grades according to customer requirements, including optimization of production and purification conditions for different mRNA, as well as selection of the most suitable lipids to meet various demands.

 

Quality Analysis Service:

• Quality Analysis Testing: Providing testing techniques to ensure the quality of mRNA and LNP meets pharmacopeia or industry standards, including purity, integrity, content, and impurity testing.
• Stability Testing: Assessing the shelf life and appropriate storage conditions of mRNA and LNP through stability testing.
• Regulatory Compliance and Documentation Support: Supplying necessary IND documents and data to support regulatory agency review and approval processes.

 

 

 

BNAP --- Contact Us

Yin-Shiou Lin, Project manager

Email : serinalin@gate.sinica.edu.tw

TEL: 02-7750-5876