Partnering with a Contract Development and Manufacturing Organisation (CDMO) offers several significant advantages for pharmaceutical companies.
Almac’s Global Heads of Business Development, Brian Eastwood (Almac Pharma Services) and Simon Hamilton (Almac Sciences) discuss the key benefits in more detail.
Why is partnering with a Contract Development and Manufacturing Organisation (CDMO)beneficial for a pharmaceutical company?
Partnering with a CDMO provides pharmaceutical companies with the provision of a team of subject matter experts who have acquired knowledge over a wide range of projects. This enables challenges to be dealt with quickly and efficiently, providing solutions based on learned experience.
Companies also benefit from access to advanced technology and equipment trains, as well as small- and large-scale manufacturing capabilities that they may not have available in-house. Significant investment is required in acquiring and operating technology, which can be an impediment in moving a project forward. By partnering with a CDMO which already has the equipment and expert resource in place, it enables pharmaceutical companies to focus efforts directly on the project and lowers unnecessary expenditure.
What are the benefits of using a single source provider for development, manufacture, and commercialisation?
The development and manufacturing of drugs requires a complex and interconnected process involving Active Pharmaceutical Ingredient (API) development, drug product development and manufacture, clinical trial management, and commercialisation. Traditionally, these functions have been outsourced to multiple providers, leading to challenges in coordination, communication, and efficiency.
One of the primary benefits of a single source provider is streamlined communication and collaboration. By consolidating the multiple activities required to one outsourcing contractor, it eliminates the need for coordination between multiple providers and ultimately the gaps in communication this creates.
Utilising a single source CDMO can also lead to significant cost and time savings. Instead of managing multiple partners, clients can focus on a single partnership, reducing overall costs and simplifying the procurement process. By utilising a sole provider to take a product from development through to commercial manufacture ensures continuity, reducing the risk of errors which would lengthen the development timeline. Providing an integrated approach helps to bring the drug product to the market and ultimately the patient faster.
How can a CDMO help a pharmaceutical company accelerate the development and commercialisation of new products?
Time-to-market is a critical factor in the pharmaceutical industry, where delays can lead to substantial revenue losses and missed opportunities within the marketplace. Partnering with an experienced and reliable CDMO from an early stage can help accelerate the development of new drugs through streamlined processes, experienced teams, and dedicated resources.
A CDMO that can provide end-to-end solutions from drug substance development, through to drug product, into manufacture and commercialisation ensures streamlined communication and collaboration at all stages. When challenges arise, particularly within chemical and formulation development, having the scientific expertise of multiple teams within one organisation creates natural problem-solving groups which enables the identification and implementation of quicker and more creative solutions.
Scientific excellence and continuity through the drug development process cannot be overstated and reduces many uncertainties inherent in a multi-supplier, multi-site process, resulting in improved coordination and efficiency with reduced to time to clinic and therefore to the market.
What are the key advantages of outsourcing development and manufacturing to a CDMO for a pharmaceutical company?
Many pharmaceutical companies aim to bring their innovative therapy to the market quickly, cost effectively, and with flexibility to meet demand. Some of the key advantages of outsourcing to a CDMO include cost savings, reduced time-to-market, access to state-of-the-art facilities, provision of subject matter experts, and providing the pharmaceutical company the ability to focus on their core strengths.
Outsourcing from early-stage chemical and formulation development can shorten development timelines and enables teams to work cohesively, understanding the drug substance fully before it moves into drug product development. The collaboration between these processes are crucial as knowledge transfer enables greater understanding of the drug product and how it will interact. A CDMO provides dedicated subject matter experts throughout the development and manufacture process who possess a wealth of experience, understanding and who can foresee possible challenges, providing solutions and a faster response rate reducing the overall time-to- market.
How can a CDMO assist a pharmaceutical company in navigating regulatory challenges and ensuring compliance?
We operate in an industry where strict regulatory guidelines must be adhered to and complied with. Non-adherence can result in detrimental effects for the company, its medication, and ultimately their patients. A CDMO must stay up to date with current regulatory guidelines, often having a dedicated team to ensure that they are followed, and quality is maintained. They can assist companies with navigating the typical challenges encountered at all stages of the drug development lifecycle.
Regulatory experts can provide expertise, offer guidance on documentation, assist with submissions, and ensure overall compliance throughout. This provides surety to the pharmaceutical company that their product will reach the market and patient as intended, without the burden of managing the regulatory process alone.
Delays due to regulatory challenges can be heavily impactful on timelines and impact the time to market, therefore also negatively impacting financial gain. Taking it a step further, working with a sole provider means that vital quality control measures are implemented consistently across all stages of the development, manufacturing, and packaging process. This ensures that each process adheres to the highest standards, reducing the risk of quality-related issues and ensuring compliance with regulatory requirements.
What factors should a pharmaceutical company consider when selecting a CDMO partner for their manufacturing needs?
Companies should consider factors such as experience, technological capabilities, regulatory and quality standards, and their compatibility with the company’s goals and values, such as their Corporate Social Responsibility (CSR) policy. In an industry where efficiency, experience, and adherence to strict guidelines is key, it is essential to select a provider that you align with, who can meet your needs and expectations and has a proven and trusted reputation within the industry.
Not all CDMOs offer the same level of stability and reliability so scrutiny on the CDMO’s long term- strategy is also essential to ensure they are reliable partners of the future. There are significant advantages to partnering with a single source CDMO who can take a product from concept to completion – streamlined communication, enhanced quality control, cost and time savings, effective resource allocation, risk mitigation and simplification of supply chain – all of which eases the burden for any biotech or pharmaceutical company.
In summary, partnering with a CDMO provides pharmaceutical companies with strategic advantages, allowing them to maintain focus on their aim of bringing innovative therapies to market efficiently and cost-effectively for patients in need.
Meet with the Almac team at CDMO Live, June 13th. Register here
