For example, in our experience, the number of chemical steps involved in making an Active Pharmaceutical Ingredient (API) has nearly doubled in the past 20 years. The molecules may simply be difficult to synthesize, perhaps because they have multiple chiral centres, or include challenging functional groups. The synthetic pathway may involve many steps, and might include difficult chemical reactions. All this has to be achieved in the face of ever-present fiscal and ever-changing geopolitical pressures.
Added to that, we also see that accelerated timelines are pretty much the new normal. Not only are some molecules, particularly in the cancer field, being given conditional approvals at an earlier stage of development, the timelines that exist for chemistry, manufacturing and controls (CMC) work to be done are shorter, adding to the challenges.
About two-thirds of recent FDA approvals for novel drugs have been on some form of accelerated timeline, so these challenges are far from unusual. And even where the molecule is on a regular pathway, there are increasing economic pressures to push it through more quickly.
All of these factors come together to create a huge amount of complexity. Contract Development and Manufacturing Organizations (CDMOs) must change the way they work if they are to help their customers navigate their way through.
At Siegfried, we have the skills to overcome the increasing complexity facing our clients. We have more than 150 years’ experience in process development and the production of customized APIs. This is testament to our ability to seamlessly scale processes from development to commercial production.
We develop and optimize manufacturing processes that are not only scalable and cost-effective but also "greener", helping our clients to achieve their ambitious sustainability targets. Our scientists excel in devising entirely new synthetic routes or optimizing existing processes, all the time working closely with our clients to keep their goals front and center.
Importantly, our highly skilled chemists will always strike a careful balance between speed and robustness when developing a new manufacturing process, in order to develop a successful and scalable synthetic route as quickly as possible.
No matter how good a process is, the capacity to produce the API needs to be available, and in the right place at the right time. We are able to provide our customers with a reliable and consistent commercial supply of high-quality products. The simple reason we are able to manage this so well lies in our broad drug substance network, which stretches from China through Europe and into the United States.
Our network of state-of-the-art labs and production facilities for drug substances ensures proximity to key markets while adhering to the highest quality standards. The complementary expertise of our seven drug substance sites enables us to build robust, de-risked supply chains, plan efficient and timely manufacturing programs, provide dual sources of supply, and offer the back-integration of intermediates and a greater ability to adjust to demand.
Our wide range of manufacturing assets gives us the flexibility to optimize capacity allocation across the network, allowing us to handle peak capacity requirements for launch quantities, and beyond. All of this effectively ‘supercharges’ our clients’ drug development journeys.
Our flexibility and responsiveness are key factors that are highly valued by our customers. The ability to structure business models, contractual arrangements, and ways of working to reflect individual needs and changing demands is critical. It is particularly important if solutions to the challenges posed by increased complexity are to be found in a timely way.
As a fully integrated CDMO, we are one of the few organizations today that can carry out the development and manufacture of APIs and finished dosage forms under one roof. Our teams of experts collaborate seamlessly with individual clients to address the unique challenges of each project.
A phase-appropriate approach and overarching lifecycle view allows our teams to work across the board, whether the drug is entering first-in-human trials, moving through the phases of clinical development, or approaching commercial launch.
Our teams of experts will do whatever it takes to make your project a success, whether you’re an emerging biotech startup or an established pharmaceutical company with an extensive pipeline of products. Our deep experience in de-risking complexity and expediting the path from product concept to commercialization can empower you to bring your innovative therapies to patients worldwide, and get them there quickly.
Reach out to our team now to tackle the complexities in your project and accelerate your path to market.