Area of presentation: ICSE General Contract Services - QbD applied to lipid-based pharmaceutical products
Speaker Name: David Lyon - Technical Director
- What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
An overriding trend is increasingly challenging molecules targeted towards more tailored, personalized medicines. Poor solubility of compounds is more and more the norm, so are specialized PK profiles required. Paediatric formulations must also typically be considered parallel to adult formulations. These challenges are not confined to new chemical entities (NCEs) but also apply to life cycle management strategies for existing compounds, oftentimes following rapid regulatory pathways such as the FDA NDA 505(b)2. Such challenges require both a range of enabling technologies and “depth” in terms of know-how, formulation experience, and specialized processing equipment. Capsugel has assembled such depth in key problem statements such as BA enhancement, targeted and modified drug delivery, and encapsulation technologies with which to design and scale specialized dosage forms. We continue to invest in modelling and predictive tools, equipment scale from concept to commercial, and expanding the application range of key technologies.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
Approximately 80% of drugs in the pharmaceutical compounds pipeline exhibit low solubility and fall into the Biopharmaceutics Classification System (BCS) Class II or IV, with the majority of these compounds being Class II (poor solubility, high permeability). BCS Class II drugs generally have poor dissolution rate (IIa) or poor solubility (IIb), and require some sort of enhancement in order to achieve sufficient exposure. A decade ago, enabling technologies were considered risky – people worried about stability issues and how Regulatory bodies would respond – but these technologies are proven now with a wide range of market precedence for enabling a BCS Class II compound using amorphous solids, lipid based, or a micronized / nano-milled presentation. However, such specialized formulation technologies require specialized expertise, know-how and manufacturing capabilities. As a result, companies developing BCS Class II compounds generally partner with specialized contract development and manufacturing organizations (CDMOs) in order to design and advance successful formulations. At Capsugel, we have not only the range of enabling technologies for enhancing BA (and modulating PK profiles) but also the “depth” in terms of predictive modelling and testing tools, product design, lab / clinical / commercial manufacturing range, and a track record of effectively advancing and scaling thousands of compounds.
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
There are a number of BA enhancement technologies that have market precedence. But how to choose the optimal technology for your applications? And to do so without parallel development programs? I will be presenting our BA enhancement technology selection methodology based on predictive modelling and specialized in-vitro testing. Rather than relying on trial and error, a fundamental, model-based approach has been developed to select the best technology according to the active principle profile. Our models and ‘reference maps’ have been developed over 20+ years and advancing thousands of compounds, and can be utilized to achieve accelerated and optimized product development, while minimizing program cost and complexity. This result is important for any pharmaceutical partner, but critical for many virtual and specialized companies – so important today in developing innovative medicines – which cannot afford multiple development programs and partners from either a cost or timeline perspective.
4. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?
Attendees will learn the basis of our predictive models and in-vitro testing tools that form the basis of our BA Technology Selection approach. Attendees will also hear how we have incorporated Quality-by-Design (QbD) and science of scale principles early in the product design phase to ensure ultimate manufacturability and rapid scaling of the formulation design. Some case studies will also be discussed which demonstrate these principles and best practices.
5. How do you see your sector of the market evolving in the next 5 years?
We see Pharmaceutical companies - large, medium and small - increasingly relying on specialized technology and CDMO partners as their business models continue to be refined. We see this trend towards partnering with specialized partners even more pronounced in problem statements such as solubility enhancement where technology range, depth of expertise, modelling tools, and equipment scale are critical. Alliances and tailored design / development / manufacturing partnerships will become increasing standard.