- Rentschler Biopharma to provide cGMP manufacturing
services for mRNA-based vaccine candidate, developed by BioNTech and
Pfizer against SARS-CoV-2 - Commercial production will be conducted in Laupheim,
Germany - Rentschler Biopharma’s innovative and highly flexible
business model enables fast, high-quality, large-scale manufacturing for
commercial supply as well as small batch production for clinical trials
for other BioNTech RNA product candidates
LAUPHEIM, GERMANY and MILFORD, MA, USA – EQS Newswire
– 8 October 2020 – Rentschler
Biopharma SE, a leading global contract development and manufacturing
organization (CDMO) for biopharmaceuticals, today announced an agreement to
serve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharma
will be responsible for key aspects of cGMP (current good
manufacturing practice) drug substance manufacturing of BNT162b2, the
mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and
BioNTech, and is currently in a global Phase 3 clinical trial.
Under the agreement, Rentschler Biopharma will
be responsible for downstream processing to provide highly
purified drug substance. Process and product-related impurities will be
effectively removed from the intermediate pool, which has been previously
derived from mRNA synthesis. This is an important step in ensuring the safety
and tolerability of a vaccine for use in humans, while at the same time
maximizing the amount of mRNA harvested from the initial production process.
Rentschler Biopharma will produce purified drug substance at its headquarters
in Laupheim, Germany.
Dr. Frank Mathias, CEO of Rentschler Biopharma,
said: “We are honored to contribute to BioNTech’s ‘Project Lightspeed’ and
their work in developing this highly innovative mRNA vaccine. To tackle the
COVID-19 pandemic, it is critical to bring high-quality, safe and effective
vaccines to the public quickly and on a large scale. At Rentschler Biopharma,
we feel it is important to do our part in combatting this virus. As a cGMP
service provider with more than 40 years of proven manufacturing expertise, we
are well suited to work with BioNTech to make their ground-breaking science a
medical reality and will work tirelessly to this end.”
BioNTech and Rentschler Biopharma will use an
innovative business model that is well suited for novel, urgently needed
technologies and allows maximum flexibility to address BioNTech’s development
and manufacturing requirements. In addition to large-scale production services
for the COVID-19 vaccine, the agreement also provides for small-batch
manufacturing of BioNTech’s other RNA programs for use in clinical trials.
Federico Pollano, SVP Global Business
Development of Rentschler Biopharma, added: “We are excited to
have the opportunity to work with BioNTech on this urgent project, as well as
over the long term. A critical success factor in all the projects we take on at
Rentschler Biopharma is close collaboration with our clients. Working in
partnership with BioNTech, we determined that the best way to address their
COVID-19 vaccine drug substance manufacturing needs was to establish a
dedicated mRNA production suite for them in our Laupheim facility. This
approach ensures capacity, staff and equipment are ready when needed without
interruption of other ongoing projects at our site. It is also an approach that
is quickly and easily scalable to meet future demands.”
About Rentschler Biopharma SE
Rentschler Biopharma is a leading contract
development and manufacturing organization (CDMO), focused exclusively on
client projects. From its headquarters in Laupheim, Germany and its site in
Milford, MA, USA, Rentschler Biopharma offers process development and
manufacturing of biopharmaceuticals as well as related consulting activities,
including project management and regulatory support. Rentschler Biopharma’s
high quality is proven by its long-standing experience and excellence as a
solution partner for its clients. A high-level quality management system, a
well-established operational excellence philosophy and advanced technologies
ensure product quality and productivity at each development and manufacturing
step. In order to offer best-in-class formulation development along the
biopharmaceutical value chain, the company has entered into a strategic alliance
with Leukocare AG. Rentschler Biopharma is a family-owned company with about
1,000 employees. For further information, please visit www.rentschler-biopharma.com. Follow Rentschler
Biopharma on LinkedIn and Facebook.
