Sing Fai Wai
Inderpendent Expert Independent Expert
Sing Fai WAI serves as the Chief Technology Officer at ImmunoCure Holding (HK) Limited, where he spearheads innovation in DNA vaccine development. With nearly three decades of leadership in biotechnology, he is the visionary founder and CEO of the start-up companies Pure Innovation Biotech Limited and Pure Asia Biotech Limited, where he has made significant contributions to advancing biomanufacturing processes across Hong Kong and China.
In his previous role as General Manager at Greenpak Biotech Limited, he played a pivotal role in obtaining regulatory approval for a Class 1 new H5 DNA vaccine for poultry, secured GMP compliance for DNA production with the Australian Pesticides and Veterinary Medicines Authority (APVMA), and oversaw the establishment of a 20-liter pilot facility. His dedication to process optimization culminated in the development of a column-less plasmid DNA manufacturing platform, along with the successful technology transfer of this platform to scale up to a 1000-liter production capacity.
Seminars
- Exploring poultry H5N1 vaccine breakthroughs using column-free processes with >95% supercoiled DNA and proven long-term stability
- Learning GMP scale-up lessons from 50L to 1000L fermentation batches while navigating regulatory requirements for novel platforms
- Analyzing process economics and applying real-world facility implementation strategies for resin versus resin-free production
As nucleic acid–based therapeutics advance from research to commercialization, ensuring quality consistency and GMP compliance across the entire product lifecycle has become a defining challenge. Participants will gain actionable strategies to strengthen quality oversight, enhance inspection readiness, and de-risk production from plasmid DNA to final drug product through proactive, integrated GxP approaches.
This workshop will address:
- Implementing risk-based Quality Management Systems (QMS) that ensure DNA integrity, traceability, and process control across both plasmid and synthetic DNA platforms
- Addressing persistent alignment challenges between interstitial standards, risk assessments, and evaluations
- Managing variability in pDNA material quality, testing methods, and evaluationcriteria, and identifying approaches to harmonize standards across the industry
- Determining which analyses are essential versus optional for Certificates of Analysis (CoAs) to balance compliance requirements with operational cost efficiency.
