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Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.
It has been widely reported that the number of highly complex and potent molecules entering development is rising, particularly in lieu of the fact that the bio/pharma industry is leaning towards personalized therapeutic offerings and drug development for orphan diseases. Pharmaceutical Technology Europe spoke with JoyL Silva, general manager of Pfizer CentreOne about trends in the contract development and manufacturing organization (CDMO) sector working with complex molecules and the benefits of the embedded model.
PTE: From your experience, what have been the biggest trends in complex ingredients over the past three decades?
Silva (Pfizer CentreOne): The market for highly potent active pharmaceutical ingredients (HPAPIs) and complex potent drug forms has grown, particularly as we place increasing focus on precision medicine and orphan diseases. This is leading to more regulatory scrutiny and the need for manufacturers with experience as well as proactive quality and compliance regimes.
High-potency manufacturing requires effective containment, cleaning, and validation to protect workers and patients. Without clear, harmonized standards from regulators, pharma manufacturers are left to provide their own solutions and set best practices to demonstrate compliance. All drug manufacturers must work to develop their own strategies and methodologies to ensure the safe handling of HPAPIs will meet regulatory expectations.
There is tremendous energy in this sector, and paired with specialized regulatory pathways for orphan drugs and cure-based therapies, the drug pipeline continues to fill with therapeutics that rely on hard-to-make, hard-to-handle APIs.
PTE: From a CDMO perspective, in which areas do you believe the pharma industry will see the most significant growth in the future?
Silva (Pfizer CentreOne): As we move towards more complex treatments and improving the therapeutic value of drugs, the technical demands on contract service suppliers will increase as pharma accelerates therapeutic innovation to meet global demand. The marketplace is shifting from the days when a CDMO was just needed to stamp out millions of pills on a tablet press for the industry. Now we are needed as technological leaders and seen as a strategic thought partner.
We’re tasked with making higher volumes of more complicated types of products and helping customers who need assistance with regulatory requirements-especially in light of rising product complexity. We’re also seeing dose delivery transitioning from injectables for the masses to a more patient-centric space where we have advanced oral solidâdose formulations, pre-filled combination devices, and other innovative means to deliver advanced oral and infusible, therapies. This includes monoclonal antibodies, gene therapies, and new classes of personalized medicines that weren’t available five years ago.
The HPAPI market is experiencing significant growth driven by demand for compounds to treat cancer, organ rejection, and conditions treated with hormone products. In 2017, this market segment was valued at $16 billion (€14.2 billion) and is predicted to grow to $27 billion (€24 billion) by 2023 (1).
More impact is also being felt by the advancing biopharmaceutical science. The biologics segment is strongly represented by innovative start-ups and smaller companies with big intellectual capital. For rising-star biopharmaceuticals with high-potential molecules, commercialization of their drugs will only be possible with access to a well-ordered supply chain and processors capable of manufacturing the drug product of their therapy. Commercial-scale manufacturing will continue to evolve rapidly to meet the growth and advancement of large-molecule biopharmaceuticals.
Currently, the level of outsourcing is 24.6%, and this is expected to grow to just over 26% by 2021 (2). All of the new aforementioned product trends will likely result in a further increase in the level of outsourcing.
PTE: How can sponsors currently benefit from partnering with an embedded CDMO?
Silva (Pfizer CentreOne): The embedded CDMO model offers drug developers an inherent value: access to the same people, science, facilities, technical innovation, and experience that made its parent a success, while protecting customers’ intellectual property.
With the experience of the parent company and its people comes the foresight needed to effectively anticipate the hurdles a compound or product might encounter, for example, during scale-up and tech transfer or when navigating the complex regulatory environment. An embedded CDMO’s experience will likely include lessons learned from scaling complex drugs and dealing with global regulators, which can then be applied to optimize a customer’s drug substance and product.
With access to global manufacturing expertise, operational excellence, and compliant facilities, embedded CDMOs are well-versed at implementing effective tech transfers and scale-up, optimized chemistries and processes. They also have the resources to further invest in capabilities, particularly in more specialized areas such as high potency manufacturing.
Many CDMOs are striving to offer a full suite of services from development through to commercial manufacture to simplify and de-risk the supply chain for their customers. To provide that service comprehensively, CDMOs must have experts that understand what it takes to go from lab or small scale to large commercial production and beyond. Embedded CDMOs are well positioned to provide this end-to-end expertise.
1. Markets and Markets, “High Potency APIs/HPAPI Market Worth 26.84 Billion USD by 2023,” Press Release, 18 April 2018.
2. Results Healthcare, “Pharma & Biotech 2017-Review of Outsourced Manufacturing,” Whitepaper, January 2017.
Pharmaceutical Technology Europe
Vol. 31, No. 8
When referring to this article, please cite it as F. Thomas, “In Safe Hands,” Pharmaceutical Technology Europe 31 (8) 2019.