In general, please tell us about Ascendia Pharmaceuticals and the services and technologies the company provides to the pharmaceutical industry.
Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that 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. Our projects range from discovery-stage molecules (NCEs) to life-cycle management projects.
We have a suite of proprietary nanoparticle technologies – NanoSol (nanosuspension), AmorSol (amorphous nanoparticles), and EmuSol (nanoemulsion) – to develop all dosage forms for new product development and GMP clinical trial materials (CTM). We execute rapid, comprehensive, and cost-effective programs for poorly soluble and complex compounds, providing both development and analytical testing services.
We partner with emerging, discovery-stage pharmaceutical companies to provide early stage formulations, generic companies that seek enabling technology, and specialty pharmaceutical companies that need formulation development or enhancements of a product for clinical testing.
Why has the topic of creating formulations for poorly water-soluble molecules become such a critical industry issue lately? Can you give us some insight into the market dynamics?
Poorly soluble molecules comprise about 60% of the new drug pipeline under development. Delivery of these compounds in a soluble form is required for many reasons. For example, adequate solubility is needed to provide sufficient drug loading for parenteral product, to establish a sufficient concentration gradient for oral absorption through the GI tract and for a high influx for topical and ocular dosage forms.
Many early stage compounds are abandoned due to poor biopharmaceutical properties, such as low solubility or permeability. In addition, in a race to be the first to market, many sub-optimal formulations of poorly soluble drugs are rushed through development. Ascendia addresses this market dynamic by partnering with drug development teams to reformulate these medicines to enhance their delivery, as well as, safety and efficacy profiles.
Specifically, what are Ascendia’s capabilities when tasked with finding an effective drug delivery method for poorly water-soluble molecules?
The unique feature that makes our company stand out is our sophisticated and thorough drug development programs, in combination with our advanced nanoparticle-based formulation technologies. We ensure the successful translation of a drug program from discovery to a marketable dosage form.
Our team of scientists has decades of big pharma experience in discovery pharmaceutics, formulation approaches, and clinical development. We understand the essential properties of compounds and the finished dosage forms required for successful early- and late-stage development. For our discovery-stage partners, we provide a tailored formulation solution for compounds that have promising efficacy in an animal/ human model, yet have some deficiency in their biopharmaceutical properties, such as poor water solubility. Often our formulation solutions provide our partner with new intellectual property for their products.
Our capabilities and culture can be best summarized by our BEST philosophy – Brilliant technology, Excellent service, Superior quality, and Trust. It is the foundation upon which our entire culture is built.
In regards to project management – how does Ascendia differ from other service companies in this market segment. How do you approach projects?
Our technical prowess, service-oriented culture, and flexibility separate Ascendia from other CDMOs. More importantly, it has helped us make the impossible possible for many of our clients.
Many CDMOs and companies have formulation capabilities. Where Ascendia stands apart is our domain expertise to solve problems when they invariably arise. We have the tribal knowledge about the molecule itself to move through those issues quickly and efficiently. That also requires tactical prowess, as well as the employees and a culture to collaborate with these domain experts who are passionate about their molecules. This is a true differentiator for Ascendia.
We take great pride in serving as a partner with a strong commitment to customer service and developing a tailored approach for each client. We have built our reputation one project at a time. It is why Ascendia has been anointed a “Partner of Choice” by many clients.
Looking ahead, what are some industry issues that pharma companies might face in the future that Ascendia is uniquely qualified to handle?
The demand for novel bioavailability and solubility enhancement methods has grown significantly and will continue to do so. Ascendia caters to this increasing demand by formulating to the specific molecule, rather than taking a one-size-fits-all approach.
We are a specialty one-stop-shop CDMO that offers tailored formulation solutions to ensure a rapid, successful transition of compounds from preclinical to the clinic. We are a formulation partner that understands rational design of dosage forms based on compound properties, possesses different technologies to address varied compound challenges, and offers flexibility in terms of time and deliverables.
Additionally, time to market will continue to be a driving factor. Ascendia routinely simultaneously utilizes its three nanotechnologies for insoluble compounds for formulation screening and in vitro assessment. The result is faster formulation development to meet tight timeframes and budget parameters.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!