January 24, 2024

Ascendia® Pharmaceuticals: Pioneering Pre-Formulation Screenings for Comprehensive Drug Development


In the fast-paced world of biopharma, pre-formulation screenings play a critical role in early stage drug development. It's not an exaggeration to say that screenings serve as a solid foundation for the successful formulation of new pharmaceuticals.


The importance of pre-formulation screenings lies in their ability to provide valuable insights that guide researchers in making informed decisions and optimizing the drug development process. For this reason, selecting a Contract Development and Manufacturing Organization (CDMO) partner with a proven track record in effective screening processes can be the difference between success and failure.


An effective screening process involves a comprehensive analysis of potential drug candidates' physical and chemical properties. This crucial step occurs before these new drugs advance into further development stages, saving drug - companies - considerable research money.


In today’s market, Ascendia Pharmaceuticals stands out as a leader in providing formulation, analytical, and manufacturing services. The uniqueness of our niche is exemplified by our approach to pre-formulation screenings. In this article, we'll consider a few of the distinctive features that set Ascendia® apart, highlighting our commitment to excellence, extensive capabilities, and the strategic use of proprietary technologies.


Evaluating Solubility and Stability


One key aspect of pre-formulation screenings is the assessment of a drug candidate's solubility and stability. Understanding how a compound dissolves in different solvents and excipients and its stability under various conditions are essential for formulating a drug with optimal bioavailability and therapeutic efficacy.


Poor solubility can hinder absorption in the body, limiting the drug's -efficacy. Through pre-formulation screenings, Ascendia scientists can identify potential solubility challenges early on and devise strategies to enhance the drug's solubility.


Ensuring Molecular Stability


Another critical consideration is the evaluation of a drug candidate's physical and chemical stability. Pre-formulation screenings help the Ascendia team identify potential degradation pathways, ensuring that the formulated drug remains stable over time.


This step is vital for maintaining a drug's potency and safety throughout its shelf life. By addressing stability issues early in the development process, Ascendia researchers can mitigate risks associated with degradation and enhance the overall quality of the final pharmaceutical product.


Guiding the Selection of Dosage Mechanism


Additionally, pre-formulation screenings contribute to the selection of suitable dosage forms and delivery systems.


Different drugs may require specific formulations, such as tablets, capsules, or injectables, based on their physicochemical properties and therapeutic objectives. Through systematic screenings, Ascendia scientists can tailor the formulation to optimize drug delivery. This ensures effective release and absorption within the body.


Platform Technology for Diverse Solutions


Ascendia distinguishes itself by offering a diverse range of platform technologies including LipidSol®, NanoSol®, EmulSol®, and AmorSol®. From lipid nanoparticles to polymers, Ascendia's four-pronged approach utilizing proprietary nanotechnologies allows for tailored solutions based on the specific needs of the drug candidate.


Whether it's oral, parental, or topical formulations, Ascendia's enabling platform ensures a strategic selection of excipients and technologies. It also sets the stage for successful drug development.


Navigating Customer Concerns and Streamlining Timelines


Customers often approach Ascendia at various stages in their development pipeline, some unsure of their specific needs. Ascendia's expertise lies in our ability to optimize individualized formulations for customers seeking to scale up their development projects.


Our platform technology enables the optimization of formulations, providing customers with a few carefully curated options that prioritize drug loading, stability, and efficacy. This streamlined approach helps customers save time, a valuable asset in the fast-paced world of drug development.


Competitive Edge in Manufacturing Capabilities


While many CDMOs offer pre-screening services, Ascendia stands apart. It goes beyond our exclusive nanotechnology platforms to utilizing all Generally Recognized As Safe (GRAS) materials. Another competitive edge lies in its cGMP manufacturing capabilities of oral and parenteral drugs.


Ascendia -possesses both non-sterile and sterile manufacturing sites, providing a holistic solution from pre-formulation screenings to cGMP manufacturing. This end-to-end capability distinguishes Ascendia as a comprehensive service provider, ensuring a seamless transition from formulation optimization to large-scale manufacturing.


Expertise: The Key Pillar of Ascendia's Success


Ascendia's expertise in providing pre-formulation screenings is rooted in its experienced team, with over 100 years of combined expertise in formulations and drug development. The Ascendia team's deep understanding of proprietary technologies, analytical methods, and regulatory requirements positions Ascendia as a reliable partner for navigating the complexities of drug development.


Breaking Barriers with Large Molecules


Ascendia's capabilities extend beyond small molecules to include large molecules and biologics, a rarity in the CDMO world.


While larger players may have the capability, Ascendia's attention to detail and ability to handle small batches sets it apart. Our commitment to building a Phase 3 sterile cGMP facility further reinforces its commitment and dedication to its clients for providing comprehensive solutions at every stage of drug development and commercialization.


Enabling a Strategic Approach to Biopharma


Pre-formulation screenings play a pivotal role in Ascendia's approach to drug development. When customers bring new molecules to a project, Ascendia conducts meticulous pre-screening activities. This involves analyzing various excipients, polymers, and solvents to ensure a comprehensive understanding of the molecule's characteristics.


The initial screening sets the stage for pre-formulation, where Ascendia explores different excipients and formulations, prioritizing stability as a paramount factor. This approach enables Ascendia to broaden the scope and identify optimal formulations early in the drug development process.


For companies intending to bring new products to market, pre-formulation screenings are indispensable in the drug development pipeline. They empower researchers with critical information to make informed decisions about the viability and potential challenges associated with drug candidates.


By addressing solubility, stability, and formulation considerations early on, pre-formulation screenings pave the way for developing safe, efficacious, and commercially viable pharmaceutical products.


Reach Out to Ascendia for an Initial Consultation


As prospective clients consider their drug development projects, Ascendia Pharmaceuticals encourages them to explore the benefits of pre-formulation screenings. Our end-to-end capabilities, expertise, and commitment to excellence, - Ascendia remains a valuable partner in navigating the complexities of pharmaceutical development. Consider Ascendia Pharmaceuticals for a collaborative journey that combines innovation, efficiency, and reliability to bring successful drug formulations to fruition.


Contact us today to learn how we can help with your next project.

   Back to articles

Want to learn more about
Ascendia's expertise?

Get up-to-date information

CALL 732-640-0058

or fill out form below and an Ascendia Pharmaceutical expert will reach out to you within 24 hours.