PR84093

DARMSTADT, Germany, May 27, 2020 /PRNewswire=KYODO JBN/--

-- Company will focus on process development and improvements for manufacturing

Baylor's Covid-19 vaccine candidates

Merck, a leading science and technology company, and Baylor College of

Medicine, Houston, Texas, USA, today announced an extension of their ongoing

collaboration to advance a manufacturing platform to fight Covid-19, designed

to accelerate transition to Phase 1 clinical trials.

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"Vaccine manufacturing is extremely complicated, so we are collaborating on a

process development approach to accelerate manufacturing of Baylor's Covid-19

vaccine candidates," said Udit Batra, member of the Merck Executive Board and

CEO, Life Science. "To fight this pandemic, we will need to produce an

unprecedented amount of vaccine in a very short period of time, and we need as

many approaches as possible to be successful."

There are no standard manufacturing templates or processes due to the

complexity and diversity of vaccine modalities, which makes production a

challenge for every organization racing to develop a safe and effective

Covid-19 vaccine. Using key learnings from their ongoing collaboration on a

schistosomiasis vaccine, Merck, along with researchers at Baylor College of

Medicine and the Texas Children's Hospital Center for Vaccine Development, is

optimizing the production processes to advance two Covid-19 vaccine candidates,

including the CoV RBD219-N1 vaccine candidate expected to enter clinical trials

later this year. Merck will help to accelerate their sustainability for

large-scale manufacturing. This collaboration will focus on improvements to

production efficiency, yield, robustness, scalability and costs.

"Our initial collaboration with Merck built an important and critical framework

for us to quickly validate and ready the production of our portfolio of

neglected tropical disease vaccines for global access," said Dr. Peter Hotez,

dean of the National School of Tropical Medicine at Baylor College of Medicine

and co-director of the Texas Children's Hospital Center for Vaccine

Development, alongside Dr. Maria Elena Bottazzi.

"The expansion of our  collaboration to include diseases of pandemic importance

will now allow us to accelerate the development of a scalable and affordable

manufacturing process of our Covid-19 vaccine candidates and enable them to

advance as quickly as possible to support vaccine production in low- and

middle- income countries," said Bottazzi, who leads the product development

activities and serves as associate dean of the National School of Tropical

Medicine at Baylor.

The Merck-Baylor teams will improve the manufacturing platform for the CoV

RBD219-N1 vaccine candidate, which was originally developed to target SARS in

2011-2016. Additionally, they will develop a new manufacturing platform for a

second Covid-19 vaccine candidate to shorten the time to enter into Phase 1

clinical trials. The goal for the partnership is to develop a suitable

manufacturing process and steps that would lead to a scale-up approach suitable

for pilot and later industrial production.

Researchers from the Texas Children’s Center for Vaccine Development first

formed a partnership with Merck's process development scientists and

biomanufacturing engineers in 2018 to advance vaccine development and

production and enhance the response to outbreaks, such as Covid-19. Because the

initial groundwork is laid through their existing process development platform

work, the team can quickly shorten the time to the clinic, realizing a key goal.

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Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine

Development received funding from NAID for their earlier work in developing the

CoV RBD219-N1 vaccine candidate and recently to initiate development of the

second Covid-19 vaccine candidate. In addition, Baylor and Texas Children’s,

through their alliance with PATH, expect to advance the Covid-19 candidates to

support access to low- and middle-income countries.  

About Merck

Merck, a leading science and technology company, operates across healthcare,

life science and performance materials. Around 57,000 employees work to make a

positive difference to millions of people's lives every day by creating more

joyful and sustainable ways to live. From advancing gene editing technologies

and discovering unique ways to treat the most challenging diseases to enabling

the intelligence of devices - the company is everywhere. In 2019, Merck

generated sales of EUR16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to

Merck's technological and scientific advances. This is how Merck has thrived

since its founding in 1668. The founding family remains the majority owner of

the publicly listed company. Merck holds the global rights to the Merck name

and brand. The only exceptions are the United States and Canada, where the

business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma

in life science and EMD Performance Materials.

SOURCE:  Merck

Your Contact: andreas.cezanne@merckgroup.com, Tel.: +49 6151 72-45946