As the era of blockbuster drugs comes to an end, pharma is moving towards drugs that are increasingly complex and made for small patient populations, creating opportunities and challenges for contract development and manufacturing organisations (CDMOs)
The CDMO industry started out decades ago as a niche service, offering additional manufacturing capacity or speciality services to pharmaceutical companies. Now pharmaceutical and biotechnology companies increasingly see CDMOs as an extension of their own development and manufacturing resources, providing capabilities that are fully integrated with their services and processes.
Many pharmaceutical companies are refocusing on their core capabilities and strengths, leading to divestments of in-house manufacturing capacities in some areas and to a growing reliance on CDMOs in others. Mid-size companies in particular are finding that partnerships can provide integrated manufacturing solutions in this new environment.
There is much at stake for pharmaceutical companies when choosing a partner for their manufacturing outsourcing needs. Proven reliability and impeccable quality standards are key to choosing a CDMO that must also be able to demonstrate the capability and experience to manage the technology transfer required to provide effective process solutions on an industrial scale.
A new approach is needed, which will require a spirit of collaboration and integration
The goal of technology transfer is to transfer product and process knowledge between development and commercial manufacturing and within or between manufacturing sites to achieve project realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement within the development phase.
Technology transfers are the most complex and time-consuming processes for a CDMO, especially because multiple partners and sites may be involved. However, successful partnerships between different teams can bring significant benefits to customers and, ultimately, to patients. Having a product developed while considering future scale and costs, and bringing together experts from all relevant functions, can make a positive difference.
Felix Faupel, head of contract manufacturing at Acino, which offers a full service, best-in-class contract manufacturing for oral solid dosage forms, says partnering and flexibility are critical for mid-sized CDMOs in this fast-changing environment.
“When pharma companies or even startups begin their developments, it is crucial for the overall project calculation to understand how their products can be upscaled, commercialised and what their cost structure may look like in the future,” he says. “The technology transfer to commercial scale is therefore a crucial step in every development journey and must be considered at an early stage. Integrated CDMO solutions can help to overcome this complexity because they evaluate a new development from end to end.”
In October, Acino Contract Manufacturing announced a strategic partnership with UK-based Quay Pharma for the formulation and development of manufacturing processes for oral solid dosage forms.
Through the partnership, both companies will broaden their customer offerings and create a smooth and integrated path between pharmaceutical development provided by Quay and all commercial manufacturing services provided by Acino. Quay can offer clients access to Acino’s extensive experience of commercial manufacturing of oral solid dosage forms, while Acino, based in Switzerland, is able to offer Quay’s scientific excellence in pharmaceutical development to its contract manufacturing customers.
Maireadh Pedersen, chief executive of Quay Pharma, says: “Quay specialises in working with new chemical entities producing innovative and most effective formulations. This fits in perfectly with Acino’s advanced capabilities in oral solid dose manufacture.
“Acino has a strong heritage in the provision of high-quality products and we look forward to working closely with Acino on being able to support our customers to successfully bring their new medicines to market.”
The future of pharma depends on getting complex drugs to patients as quickly as possible. To make this happen a new approach is needed, which will require a spirit of collaboration and integration. This means working together to bring the drugs patients need through the different stages of clinical development to successful market registration. This is what we all want to achieve.
For more information please visit acino.swiss