APR Sept/Oct 2023 - 12

Ascendia Pharmaceuticals®
661 US Highway One, Unit B
North Brunswick, NJ 08902
Tel: 732-638-4028
Email: bd@ascendiapharma.com
www.ascendiapharma.com
COMPANY DESCRIPTION
Ascendia Pharmaceuticals
is a specialty formulation CDMO
for biologics and gene deliveries, as well as small molecules. It
provides custom sterile and non-sterile enabling formulations,
along with analytical methods for new chemical entities, complex
dosage forms, and 505(b)(2) product development, as well as
OTCs and nutraceuticals.
Ascendia® exceeds customer expectations from pre-formulation
through to commercialization. The CDMO is expert in sophisticated
formulations, as well as cGMP sterile and non-sterile
clinical trial and commercial manufacturing. Clients have anointed
Ascendia a " Partner of Choice " based upon the successes achieved.
Ascendia's formulation experts make the Impossible Possible by
developing formulations for projects when others have failed.
These successful formulations use all GRAS materials to eliminate
regulatory burden.
COMPANY BACKGROUND
Founded in 2012, Ascendia offers a comprehensive suite of preformulation,
formulation development, cGMP manufacturing,
and ICH stability services for all dosage forms using proprietary
nano-technologies in nanoemulsion, nanoparticles, and
amorphous technology platforms.
foundation of success on its customer-centric culture that exudes
its BEST philosophy (Brilliant technology, Excellent service,
Superior quality, and Trust).
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| September/October 2023
MARKETS SERVED/FACILITIES
Headquartered in North Brunswick, NJ, Ascendia's 60,000
square-foot facility has Class 10,000 (ISO 7) and Class 100 (ISO 5)
cleanrooms, as well as Class 10,000 (ISO 7) manufacturing suites.
Ascendia's expertise in discovering the most effective formulation
development for poorly-soluble molecules and biologics
aligns the CDMO with pharmaceutical and biopharmaceutical
companies developing new drugs, as well as, new formulations
for existing drugs.
PRODUCTS, SERVICES & CAPABILITIES
Ascendia delivers sophisticated formulations to enhance
bioavailability and solubility using four proprietary
nanotechnologies - AmorSol®, EmulSol®, LipidSol®, and NanoSol®.
It develops solutions for all dosage forms for small molecules and
biologics, including lipid nanoparticles that encapsulate and
deliver gene therapy. Its facility maintains stability chambers for
conducting non-GMP and cGMP stability studies in accordance
with ICH guidelines. Ascendia stability studies:
* determine robustness of formulation prototypes during early
development
The company built its
* ascertain chemical and physical integrity of lead formulations
before advancement into animal/toxicology studies
* assure final formulations meet stability for clinical trial
Ascendia offers fast, flexible solutions, along with small-batch size
services for conducting first-in-man studies efficiently to stay on
schedule and within budget.
http://www.ascendiapharma.com
APR Sept/Oct 2023

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