One common issue is scalability

For instance, a small-scale formulation may not accurately represent how a drug behaves or performs when produced on a larger scale. This discrepancy can lead to unexpected results or difficulties when attempting to mass-produce the drug for clinical trials or commercialization.

Another challenge is consistency

Achieving consistent quality and potency in small batches can be difficult, but consistency is critical for ensuring reliable results in research and clinical trials. Variability in formulation can affect the drug's efficacy and safety profile, making it harder to assess its true potential.

Small-scale formulations may be more prone to contamination or degradation over time

Maintaining stability and purity ensures the drug remains effective and safe throughout its development.

Maximizing The Impact of Limited Resources

From a budgetary standpoint, working with small-scale formulations can also be costly and time-consuming.

Producing and analyzing these formulations requires specialized equipment and expertise, adding to the overall drug development expenses.

While small-scale formulations are essential for early-stage research, they frequently pose multiple challenges regarding scalability, consistency, stability, and cost-effectiveness. Overcoming these challenges is crucial for CDMOs to be valuable partners to pharma companies aiming to develop and successfully bring new therapies to market.

We Help Overcome Small-Scale Challenges

With our extensive experience and expertise, Ascendia is not just capable but adept at developing and evaluating a variety of formulations for preclinical non-GLP and GLP studies. This assurance instills confidence in our clients, which is repaid by our ability to overcome even the most difficult small-scale formulation challenges.

At Ascendia, we understand that each drug has unique challenges. We’ve developed methods for conducting formulation screening studies with as little as several milligrams of drug substance explicitly tailored to your requirements. This personalized approach should make you feel valued and understood.

After screening, our formulation development includes feasibility studies to determine the compatibility of excipients, active ingredients, delivery components, formulation selection, and optimization.

A Complete Suite of Drug Development Services

Ascendia offers a comprehensive suite of drug development services. These include statistical experimental design, short-term and accelerated stability studies, and analytical method development and validation.

We’ve designed our comprehensive services to address the specific challenges of complex, small-scale formulations, ensuring the reliability and safety of your drug development process.

Using our extensive expertise in modeling and simulation, we can predict the animal PK profile and propose an efficient formulation strategy for preclinical studies accordingly. Often, these small-scale formulations are provided in liquid form and developed for various routes of administration — oral, IV, IP, SC, etc. Our advanced technology and team's proficiency are critical to our ability to deliver high-quality services.

Solutions

Depending on the drug candidate's solubility properties, lipids, surfactants, complexation agents, and co-solvents can be added to increase solubility and enhance solubility and bioavailability for initial animal testing.

Suspensions

Particle size and the selection of a suspending vehicle are frequently critical factors impacting the stability and dissolution rate. Micronization of the drug substance by jet milling — or wet milling in a suspending vehicle — can, therefore, be essential to obtain good bioavailability of a poorly water-soluble drug substance.

Nano-Suspensions

The preparation of nano-suspensions of a poorly water-soluble drug substance further increases the dissolution rate (by increasing the surface area). A nano-suspension of a poorly water-soluble drug substance may show a faster dissolution rate and a higher solubility/bioavailability when compared to a micronized suspension.

Emulsions

If dictated by solubility data (in oily vehicles, co-surfactants, and solvents), an emulsion — a fine dispersion of oil droplets — can be formulated to improve the initial probability of success. The drug may be dissolved or suspended in the oily liquid, formulated as an emulsion, and incorporated into the solid matrix or aqueous liquid phase.

Lipid Nanoparticles

LNPs offer an innovative drug delivery method for targeting certain tissues with lipoplexes composed of ionizable lipids varied in their structures and properties. This will open the doors for numerous opportunities in drug delivery of biologics due to efficient encapsulation and greater protection of the biologics within LNP cargo.
LipidSol® by Ascendia is an LNP platform technology that provides different process methods, such as microfluidics, thin film hydrating, extrusion, high pression homogenization, nanoprecipitation, and emulsification/double emulsification to make LNPs for various therapeutic modalities with both hydrophilic and lipophilic properties.

Reach Out Today

By partnering with Ascendia, you gain more than just a CDMO partner. You gain the power to make informed decisions, mitigate risks, and confidently bring high-quality pharmaceutical products to market. Our services instill optimism in project success, making us the ideal partner for your drug development needs.

Contact us today to learn more about how Ascendia can drive the success of your pharmaceutical development programs. Let us be your trusted partner in ensuring the stability and safety of your products.

Learn more about Small-Scale Formulations

Small-Scale Formulations for Pre-Clinical Testing

These formulations are crucial in the early stages of drug development when scientists test new compounds to determine their effectiveness and safety.