Liying Guay - Dark Horse Consulting

0

years of experience

0

years at DHC

Liying

's Service Domains

CMC

Quality & Compliance

Regulatory

Before joining Dark Horse Consulting, Liying served as the head of process science and technology department in Tessa Therapeutics. Tessa Therapeutics is a clinical-stage biotechnology company based in Singapore that is developing a portfolio of autologous and allogeneic cell therapy assets.

Liying’s career started at A-bio Pharma, a CDMO start-up company in Singapore, where she was involved in process development of cell culture process for the production of clinical phase biologic products for various clients. She had supported in the many clients’ projects by conducting process monitoring and experiments as well as clinical phase 1 cGMP tech transfer and production via various cell culture processes with various system and platforms ranging from different types of bioreactors and mode of production.

In 2010, Liying joined Baxalta, Singapore as process expert. She had involved in the Baxalta’s green field start up project to build and start up the cGMP facility in Singapore for the commercial production of a biologic product. She was involved in the tech transfer of the product from the sister site to the Singapore plant. She had also supported the preparation of the CTD module documents and audits (FDA / EMA) for the BLA / MAA submission. She had served as the subject matter expert (SME) for the production bioreactor process, performed process qualification and process validation, developed the control strategy via risk-based approach, and conducted process monitoring to ensure the process was consistent and well controlled. Part of her responsibilities were to support the plant daily activities such as troubleshooting, process monitoring and investigation via root cause analysis. In addition, she had supported the implementation of an online process monitoring platform (Discoverant) as well as electronic batch records for the manufacturing of a second commercial product in the second suit of the Baxalta facility. During her 7 years at Baxalta, she had also completed 2 six-sigma projects with total savings of ~USD$9M: one using DMAIC and the other, DIDVO approach.

Liying left Baxalta to join Abbvie, Singapore as cell culture lead in 2016 to support the tech transfer and green field project to build and start up the cGMP facility in Singapore for the commercial production of a monoclonal antibody. Her responsibilities in Abbvie Singapore were similar to that at Baxalta and she additionally supported in downstream activities. She had also supported the implementation of the electronic batch records for the manufacturing of the product.

in 2018, Liying joined Tessa, Process, science and technology department (aka MSAT), which consisted of process development, analytical development and manufacturing. She was responsible for the product and process Chemistry, Manufacturing and Controls (CMC) and manufacturing lifecycle activities, Her main role was to ensure that product quality and process manufacturing requirements meet applicable current GxP and regulatory requirements. She was involved in the CMC activities for 2 autologous CGT products: one in the clinical phase 3 and the other in clinical phase 2. She had implemented the QbD approach in identifying the CQA, CPP and KPP for the 2 CGT products. She had also successfully completed the tech transfer and comparability runs of a phase 2 CAR-T product in preparation for the pivotal trial from a phase 1/ 2 clinical manufacturing facility to Tessa cGMP facility for pivotal and commercial manufacturing. She alsosupported Heath Science Authority (Singapore) audit for GMP certification.