The new 18,000-square-foot State-of-the-Art GMP
synthesis facility will help meet the growing demand for high-quality,
CRISPR-enabled in vivo and ex vivo therapeutics.
United
States: On
Thursday, 11th May 2023, Synthego Corporation, a leading provider of genome
engineering solutions, announced the inauguration of its cutting-edge GMP
synthesis facility. This new 18,000-square-foot facility will help pharma and
biopharma companies meet the growing need for high-quality, CRISPR-enabled in
vivo and ex vivo medicines, including IND, NDA, or BLA enabling clinical
investigations. The new facility uses cutting-edge equipment and technologies,
including multiplexed manufacturing lines, fully automated controls, and an
integrated Manufacturing Execution System (MES), and operates 24/7. It also
adheres to current Good Manufacturing Practices (cGMP). By producing a variety
of oligonucleotides, including synthetic single guide RNAs, the company is able
to set the bar for quality and compliance in the production of gene editing
components. Additionally, the facility also has spaces specifically designated
for process research, analytical testing, and quality control, guaranteeing
that every facet of the manufacturing process is strictly regulated.
The new facility has been designed to
fulfill the requirements of both domestic and international regulatory
authorities which includes FDA, EMA, MHRA, and Health Canada. With the launch
of the facility, Synthego is in a great position to continue offering its
customers the manufacturing of custom RNA molecules for development of cell and
gene therapeutics.
According to the Founder
& CEO of Synthego Corp.,
"We are pleased to open Synthego's new GMP facility, solidifying our
commitment to provide partners with the highest quality CRISPR guides for the
clinical development of therapeutics. This represents a significant step
towards removing industry bottlenecks and helping accelerate access to
life-changing and lifesaving CRISPR-enabled cell and gene therapies." said
Paul Dabrowski, CEO of Synthego. "The design of this facility is the
fruition of a decade of experience creating guide RNAs and engineering cells
and sets the standard for quality and efficiency of GMP CRISPR reagent
manufacturing."
According to TechSci Research,
the
establishment of a cutting-edge facility will provide the company a competitive
edge in the genetic engineering market. Strong manufacturing facilities for
guide RNA can result in reduced costs, quick turnaround times, and
better-quality control. These factors may put the facility in a favored
supplier position for companies developing CRISPR-based therapies. The inauguration
of a cutting-edge facility for the production of guide RNA for CRISPR genomic medicines
indicates the growing interest and investment in this field. Given that guide
RNA is an essential part of the CRISPR gene editing process, this points to a
significant market potential for CRISPR-based therapeutics. The establishment
of a specialized facility denotes an increase in guide RNA synthesis
capability. This will probably meet the growing demand for CRISPR-based
treatments and aid in the development of genetic drugs. The increased
production capacity will help with the scaling issues that frequently occurs in
the field of biotechnology.
With its headquarters
in Silicon Valley, Synthego serves prominent organizations from over 32
different countries as well as eight of the top ten biotechnology businesses
and twenty-four of the top twenty-five universities worldwide. The facility is
prepared to focus on the increasing demand for CRISPR-based therapeutics. As CRISPR
is viewed as a game-changer by scientists for a variety of reasons. The main
benefit, especially when compared to more traditional gene-editing methods, is
perhaps how simple CRISPR is to employ. Researchers swiftly produce cell and
animal models using CRISPR genome editing, accelerating the study of diseases
including cancer and mental illness. CRISPR is also now being explored as a
quick diagnostic tool in genetic engineering.