The small molecule medicine market has entered a transition phase. Drug candidates in the development pipeline are increasingly innovative, complex and highly potent specialty medicines. They enable drastically improved treatment opportunities for patients in need. Fast track regulatory approval programs have been introduced to meet these needs by shortening the time to market and compressing timelines for the developer.
At the same time, the increased complexity of the molecules can lead to challenges in development and manufacturing, including poor solubility and a decreased bioavailability. To succeed, you need to partner with a provider who can help you navigate a dynamic environment, balancing investment and timeline risks with market opportunities.
We start by gaining a full understanding of your compound, target product profile and commercial objectives. Our multidisciplinary teams bring unique perspective to drug programs at the earliest stages of development. QbD and ultimate manufacturability are factored into our problem-solving approach and product design.
To pace your investments throughout the clinical stage, services and equipment are always phase appropriate. We always keep your ultimate goal in mind but focus on your next milestone. Experienced, multi-disciplinary teams work closely with you to streamline your development process across API and drug product and prepare you for commercialization.
Our solutions are tailored to short timelines without compromising the cost-effectiveness, robustness and scalability of your process. You can rely on our processes to handle the unexpected, and we will respond quickly when unexpected challenges arise. We have supported 36% of breakthrough therapy designation launches in small molecules, demonstrating our ability to accelerate when appropriate.
The long-term supply strategy of a drug needs to be determined while approval and market demand are still uncertain. You can mitigate investment risk by partnering with us in unique business models that provide flexible supply solutions adapted to different market demands. Our engineering team can build tailored capacity optimized to your needs.
We can help you avoid the cost of poor quality through our early sourcing of intermediates and raw materials. Our trusted, robust and global supply network is known to deliver on time; and our transparent working culture keeps you informed in the case of unexpected events. During the entire lifecycle of your medicine, we strive to provide you with uninterrupted delivery in a dynamic market.
Our experienced chemists utilize a vast toolbox including complex chemistry, supporting a broad set of synthesis options to find an optimized, scalable and efficient manufacturing route. Lonza provides specialty chemistry such as ozonolysis, phosgenation and diketene-based synthesis, where appropriate.
We have proven experience in highly potent active pharmaceutical ingredients (HPAPI). Our HPAPI capabilities range from small to large scale across drug substance and drug product, and allow you to seamlessly scale your drug candidate to prepare it for launch or support in market demand.
Regulatory consulting based on 40 years' regulatory experience, complemented by a toolbox of analytical services to characterize your process in line with your goals. We consult with you on your filing strategy and prepare you for success.
With our depth in technologies and proprietary process equipment, we can address dissolution rate or solubility issues. Technology selection methodologies based on predictive modeling enable the rapid selection of the right technology for your compound and target product profile.
To modulate pharmacokinetics, improve delivery, and enhance bioavailability of your target molecules, choose from a full range of drug delivery approaches combined with experience of our scientists in advancing thousands of drug candidates.