Scientific progress has transformed the discovery of new therapies and the treatment of cancer over the past decade.
As the fastest-growing sector of drug development representing 38% of the R&D pipeline1, oncology has benefited from advancements in science and technology, with research scientists having a better understanding of the biology, immunology, and genetics of cancer leading to the development and approval of powerful targeted therapies, capable of causing the complete durable elimination of tumours.
Precision oncology is transforming the way patients are treated. According to the latest Global Trends in R&D report by IQVIA, in the past decade 31% of all global launches of novel active substances (NASs) have been for oncology indications. Totalling 184 launches and including some of the most groundbreaking new treatments in immuno-oncology and rare cancer treatments, as well as next generation biotherapeutics – including mRNA and cell and gene therapies.
Many patient populations that were previously treated with nonselective chemotherapies are now receiving precision targeted immunotherapies that are tailored specifically to their disease. By their nature, targeted cancer therapies are more complex than conventional chemotherapies, making their formulation more challenging, they are often classified as being highly potent and as such, require specialized facilities, equipment, and contained processing technologies.
In fact, the global market for highly potent active pharmaceutical ingredients (HPAPIs) is currently on a growth fast track, with highly potent drug products constituting the majority of the oncology pipeline. In 2020, 75% of HPAPI revenue was due to the large volume of highly potent oncology drugs.2
Coupled with challenging processing requirements and smaller patient populations, many biopharmaceutical companies seek to outsource the manufacture and packaging of their oncology drug products to specialist CDMOs with experience in highly potent processing and expert containment solutions. Such CDMOs process multiple potent therapies on behalf of many biopharmaceutical companies some of which have been in operation for decades, giving them a breadth of expertise that may not always exist within biopharmaceutical companies. With stringent regulatory and safety requirements, biopharmaceutical companies are advised to conduct full due diliengence to ensure their selected vendor is able to meet the processing requirements of their life-saving drug product.
Key considerations for selecting your CDMO for your high potent Oncology drug product
Assessing a CDMO’s capabilities, track record, compliance history, and ability to provide long-term support is key to the success of any outsourcing decision. However, the additional complexity and higher regulatory hurdles involved in processing HPAPIs makes choosing the right CDMO for life-saving oncology products even more important and biopharmaceutical companies should take the following into account:
Vendor assessment should be based on the CDMO’s ability to handle and process HPAPIs in a way that keeps operators safe and is in compliance with regulatory requirements.
Organizations may use different terms when classifying HPAPIs: occupational exposure bands, occupational health categorizations, control bands, and some larger companies may use their own in-house classifications. Irrespective of the terminology used by the outsourcing biopharmaceutical company, the chosen vendor should have an established robust risk assessment framework to make an accurate assessment of the safety and health parameters of the compound.
Occupational exposure limit (OEL) is a term that all companies understand. Companies need documented OELs, as well as working with industrial hygiene experts who can interpret OEL data and evaluate the workplace requirements.
The importance of making an accurate OEL assessment should not be underestimated as when it comes to highly potent compound safety, facilities must develop containment strategies that strike the right balance to ensure the appropriate solution for the product.
Selecting your outsourcing partner based on their risk assessment framework and approach to contained engineering solutions should form one of your primary selection criteria.
Often companies outsource early-stage development and clinical manufacture of their highly potent oncology drug product due to a lot of ‘unknowns’ with the intent that once formulations and manufacturing processes have been established and optimized, they will transfer activities back in-house. However, due to many processing complexities and perhaps required internal capital investment it is often deemed beneficial to continue the outsourcing relationship. Comparing a CDMOs ability to support your product needs from development through to commercialization will be imperative and could prevent the need to change vendors thereby reducing risk, time, and associated costs of the development program.
In addition, HPAPI-related outsourcing decisions should, perhaps, not be limited to the initial commercial launch of a product, as it can take many years beyond commercial approval for an oncology therapy to reach peak demand. The approved process validation scale may not meet peak demand, meaning that a secondary supplier may be required.
The outsourcing company should future-proof their decision and assess the maximum commercial manufacturing and packaging outputs an outsourcing partner may offer and their ability to scale up, and meet anticipated peak demands.
Oncology product pipelines today require more flexibility in manufacturing than ever before. With smaller batch sizes, accelerated development programs condensing manufacturing timelines, a CDMO that has the ability to efficiently adjust production volumes to meet market demands thereby providing flexibility and adaptability will be key to getting your oncology drug to market quickly.
Streamlining Supply Chains
With valuable life-saving oncology drug products, streamlining your product supply chain can be advantageous to reduce the number of handoffs, technical transfers and risk to the product. Reviewing a vendor’s full service offering, whether it be in-house analytical support, dedicated high potent packaging solutions or global distribution in support of clinical trials or ultimately product launch will prove beneficial if the scope of your outsourcing requirements change. Leveraging end to end expert solutions will minimize your supply chain complexity and risk.
Advances in the molecular understanding of cancer with the increased focus on developing targeted therapies, coupled to regulatory support for getting novel treatments to market quickly has changed the outsourcing paradigm for highly potent oncology drug products.
Biopharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging and commercialization of their oncology products containing highly potent active pharmaceutical ingredients. With the growing complexities of safe handling highly potent molecules and the associated regulatory focus, companies looking to outsource must conduct due diligence to identify specialist CDMOs able to deliver safe, scalable and flexible processes with additional in-house services, delivering end to end solutions that can be tailored to meet changing needs through the development lifecycle to global commercial supply.
- IQVIA: Global Trends in R&D 2023
- Grand View Research: High potency active pharmaceutical ingredients market size, share & trends analysis report by product (synthetic, biotech), by manufacturer type (in-house, outsourced), by drug type, by application, by region, and segment forecasts, 2021–2028 (website), 2021. https://www.grandviewresearch.com/industry-analysis/high-potency-active-pharmaceutical-ingredients-hpapi-market
Outsourcing your High Potent Oncology Drug Product by Rebecca Coutts. – 10th March, 2023, | As seen in Manufacturing Chemist.