Pharmaceutical developers typically encounter numerous challenges when formulating dosages for new drugs. These challenges can significantly impact their products' efficacy, safety, and marketability.
Various factors contribute to such challenges. Among the most common are the physicochemical and biopharmaceutical properties of the drug substance, its intended route of administration, target patient population, and regulatory requirements.
Interestingly, many prospective customers first contact our team at Ascendia Pharmaceutical Solutions based on sophisticated formulation technologies. As a result, many need to be fully aware of what we have to offer when developing dosage formulations. Our initial consultation often involves presenting potential solutions based on provided information and how Ascendia’s capabilities and formulation technologies can potentially help to resolve the unique challenges of their compounds.
Challenges Frequently Encountered During the Dosage Formulation Stage
Some of the critical issues faced by pharmaceutical developers during the dosage formulation process include:
- Bioavailability and Stability: Many drug compounds have poor solubility or stability. Unsatisfactory performance at this stage makes it difficult to formulate them into a dosage that ensures adequate absorption and therapeutic effect. Developers must employ micronization, nanoparticle formulation, and complexation techniques to improve bioavailability and stability.
- Dosage Form Selection: The appropriate dosage form (e.g., tablets, capsules, injectables, etc.) is crucial for ensuring patient compliance and therapeutic efficacy. Drug development teams must consider factors such as dosing frequency, patient convenience, and the nature of the drug substance during formulation development.
- Dosing Precision: Achieving precise dosing is essential to achieve consistent therapeutic outcomes and minimize the risk of adverse effects. Formulation scientists must carefully control several factors. These include particle size distribution, uniformity of content, and dissolution rates to achieve accurate dosing.
- Manufacturability: Dosage forms must be scalable and reproducible. They must also be compatible with manufacturing processes to ensure cost-effective production on a commercial scale. Developers must consider formulation complexity, equipment compatibility, and process robustness during formulation development.
How CDMOs Assist During the Dosage Formulation Stage
Contract Development and Manufacturing Organizations (CDMOs) such as Ascendia have become sought-after partners for biopharma research. Ascendia offers specialized expertise, proprietary infrastructure, and resources to overcome formulation challenges. Some of the ways CDMOs can support pharmaceutical developers include:
- Formulation Development: CDMOs employ teams of formulation scientists with expertise in various dosage forms and drug delivery technologies. These experts collaborate with pharmaceutical developers to design and optimize formulations that meet the specific requirements of the drug substance and target patient population.
- Analytical Services: CDMOs provide comprehensive analytical testing services to assess the physicochemical properties, stability, and performance of formulated dosage forms. Advanced analytical techniques, such as spectroscopy, chromatography, and imaging characterize drug products and ensure compliance with regulatory standards.
- Process Optimization: CDMOs assist in optimizing manufacturing processes to improve efficiency, reduce costs, and enhance product quality. Through process development and scale-up studies, CDMOs help streamline production workflows and identify critical process parameters influencing product performance.
- Regulatory Support: CDMOs possess in-depth knowledge of regulatory requirements governing pharmaceutical development and manufacturing. They assist drug teams prepare regulatory submissions, conduct stability studies, and navigate the complex regulatory landscape to expedite product commercialization.
The Most Valuable Resource: Time Spent Well
In the biopharma development process, time is an invaluable resource. Development timelines and their milestones directly impact the success and competitiveness of a product.
For several reasons, a responsible CDMO must uphold the criticality of not inadvertently wasting time during biopharma development.
- Competitive Landscape: Numerous companies are vying to bring innovative therapies to market. Time-to-market is crucial in gaining a competitive edge and capturing market share. Delaying product development can allow competitors to introduce similar therapies, reducing a product's market potential and profitability.
- Patent Exclusivity: Patents play a significant role in protecting the intellectual property (IP) rights of biopharmaceutical products. Securing patents early in the development process is essential, as they. Patents establish market exclusivity and recoup investment costs. Patent protection, however, can be inadvertently limited due to the time to develop and commercialize a product. Wasting time during development can ensure the duration of patent exclusivity is maintained. Lost time exposes the product to competition from generic or biosimilar alternatives sooner than anticipated.
- Resource Allocation: Biopharma development requires substantial financial, human, and technological resources. Wasting time on inefficient processes, failed experiments, or indecisiveness can lead to resource depletion and increased development costs. Efficient resource allocation is crucial for optimizing development timelines, maximizing productivity, and preserving financial sustainability throughout the product lifecycle.
- Clinical Development: Clinical trials, where developers evaluate the safety, efficacy, and tolerability of a drug in human subjects, represent a critical phase in biopharma development. Clinical trial recruitment, patient enrollment, and data collection delays can prolong the time required to demonstrate product efficacy and obtain regulatory approval. Moreover, extended clinical development timelines can extend the time patients wait to access potentially life-saving or life-improving therapies.
- Market Opportunities and Patient Needs: Timely delivery of innovative biopharmaceutical products is essential for addressing unmet medical needs, improving patient outcomes, and advancing public health. Delayed development can deprive patients of access to breakthrough therapies, exacerbating health disparities and compromising quality of life. By expediting product development, biopharma companies can capitalize on market opportunities, meet patient demand, and fulfill their commitment to advancing medical science and patient care.
Ascendia's Hedge Against Blind Alleys: Our Platform Technologies
At Ascendia Pharmaceutical Solutions, we understand the intricate challenges of dosage form selection and optimization in the biopharma development landscape. Our commitment to innovation and excellence drives us to deliver unparalleled services that differentiate us. We have an approach built upon our BEST (Brilliant technologies, Excellent service, Superior quality, Trust) philosophy. The unique capabilities and platform technologies set Ascendia apart as a leading CDMO in the biopharma niche.
Understanding Dose Form Selection and Optimization
Before clients approach Ascendia, they often have a clear vision of their drug's dosage form and route of administration. However, optimizing these formulations requires expert guidance and specialized technologies.
Our role begins with refining and enhancing existing formulations to meet the stringent demands of efficacy, safety, and patient compliance.
The Ascendia Advantage: Platform Technologies
Central to our approach is our arsenal of in-house platform technologies – AmorSol®, EmulSol®, LipidSol, and NanoSol®. These proprietary technologies empower our researchers to navigate the complexities of dosage formulation with precision and efficiency.
Whether it's small molecules or large biologics, we tailor our platform technologies to suit the unique characteristics of each drug substance.
Holistic Optimization with Design of Experiments
At Ascendia, we adopt a holistic approach to dosage form optimization, leveraging Design of Experiments (DOE) methodologies.
We craft formulations that surpass industry standards by meticulously analyzing critical attributes such as drug loading, stability, particle size distribution, and surface charge.
Our commitment to quality and innovation drives us to continuously refine and improve our formulations, ensuring optimal performance across diverse therapeutic applications. We use generally recognized as safe (GRAS) substances to ensure product safety. Additionally Ascendia adheres to cGMP manufacturing to assure proper design, monitoring, and control of our processes and facilities.
Maximizing Efficacy, Safety, and Viability
Ascendia platform technologies enhance drug solubility and bioavailability, mitigate potential toxicity, and improve patient outcomes. We bypass first-pass metabolism and optimize drug absorption through lymphatic pathways by leveraging advanced lipid nanoparticles and formulation strategies.
This innovative approach expands the therapeutic potential of our client's products, unlocking new possibilities for patient care and treatment efficacy.
Educating and Empowering Our Clients
At Ascendia, informed decision-making is the cornerstone of successful drug development. We prioritize client education, providing comprehensive insights into the intricate interplay of formulation technologies and therapeutic outcomes.
Through transparent communication and collaborative partnerships, we empower our clients to make informed choices that accelerate the path to regulatory approval and commercialization.
Partner with Ascendia for Cutting-Edge Dosage Development Solutions
As you embark on the journey of biopharma development, trust Ascendia Pharmaceuticals to be your partner in innovation and success.
Our unwavering commitment to excellence and advanced formulation platform technologies position us as a trusted leader in the CDMO landscape. Take the next step towards realizing your drug development goals—engage in a quick conversation with Ascendia and unlock the full potential of your formulations.
Contact us to learn more about our manufacturing capabilities.