Mfg News: Gilead, Sana Biotechnology & BioNTech
A roundup of manufacturing news from Gilead Sciences, Sana Biotechnology, and BioNTech. Highlights below.
Gilead Names New Executive VP, Pharma Development, Mfg
Gilead Sciences has appointed Stacey Ma, PhD, currently the Executive Vice President and Head of Technical Operations at Sana Biotechnology, a Seattle, Washington-based bio/pharmaceutical company developing cell and gene therapies, as Executive Vice President, Pharmaceutical Development and Manufacturing.
Dr. Ma will become a member of the company’s senior leadership team, reporting to Daniel O’Day, Gilead’s Chairman and CEO. Dr. Ma will assume responsibility for Gilead’s Pharmaceutical Development and Manufacturing organization, effective July 18, 2022. Dr. Ma will succeed Dr. Taiyin Yang, currently Executive Vice President, Pharmaceutical Development and Manufacturing, who is retiring from Gilead after nearly three decades.
Dr. Ma has more than 25 years of experience in process, pharmaceutical and analytical development, quality, technical product and supply-chain management, and global manufacturing operations. She joins Gilead from Sana Biotechnology, where she most recently served as Executive Vice President and Head of Technical Operations. Prior to Sana, Dr. Ma was the Global Head of Innovation, Manufacturing Science and Technology in Genentech’s/Roche’s Pharma Technical Operations.
Source: Gilead Sciences
Sana Biotechnology To Relocate Mfg Operations
Sana Biotechnology, a Seattle, Washington-based bio/pharmaceutical company developing cell and gene therapies, has entered into a lease agreement to develop a new approximately 80,000-square-foot manufacturing facility in Bothell, Washington.
The Bothell facility will replace a manufacturing facility in Fremont, California and is designed to support the manufacturing of Sana’s multiple product candidates across the company’s cell and gene therapy portfolio as they enter late-stage clinical development and early commercial supply. Sana says it will continue to work with contract manufacturing partners to expand its footprint and production capacity.
The company expects this move will result in over $100 million in cost savings in the next three years (as reported on June 1, 2022).
In addition to the new manufacturing plant, the company announced it has appointed Snehal Patel, formerly Global Head and Vice President for Cell Therapy Manufacturing at Bristol Myers Squibb, to lead Sana’s internal and external manufacturing and Julie Lepin, formerly Vice President, Regulatory Affairs for Oncology at Amgen, to lead regulatory affairs.
Source: Sana Biotechnology
BioNTech To Break Ground on Vaccine-Mfg Facility in Africa
BioNTech, a Mainz, Germany bio/pharmaceutical company, reports that it will hold a ground-breaking later this month (June 23, 2022) for its initial African mRNA manufacturing facility in Kigali, Rwanda, where the company’s first BioNTainer modules are planned to be delivered by the end of 2022. BioNTainer modules are turnkey mRNA manufacturing facilities based on a container solution consisting of one drug substance and one formulation module, each called a BioNTainer.
Earlier this year (February 2022), BioNTech announced plans to establish scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution named BioNTainer. Each module is built of six ISO sized containers (2.6 m x 2.4 m x 12 m) to allow for vaccine production in bulk (mRNA manufacturing and formulation) while fill–finish will be taken over by local partners. Each BioNTainer is a cleanroom, which BioNTech equips. Together, two modules require 800 square meters of space and offer an estimated initial capacity of for example up to 50 million doses of the Pfizer/BioNTech COVID-19 vaccine each year. The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states. BioNTech also expects to ship BioNTainers to Senegal and potentially South Africa in coordination with the respective countries and the African Union.