In the dynamic landscape of pharmaceuticals, the collaboration between pharmaceutical or biotech companies and Contract Development and Manufacturing Organisations (CDMOs) has become crucial to corporations of all sizes. This might lead you to ask yourself: how can I choose the right CDMO partner for my company’s needs?
Ensuring you’ve teamed up with the right CDMO can help chart the course towards your company’s success, and impact the efficiency of drug development and biomanufacturing processes along the pipeline.
So, whether you're a start-up, a mid-sized company, or a large pharmaceutical corporation, here's a helpful guide on how to choose the perfect CDMO partner for all your biopharmaceutical needs.
What is the Purpose of a CDMO?
While biomanufacturing processes are used across many industries, pharma harnesses this technology for a variety of purposes including engineering and producing enzymes and proteins that are used in drug and vaccine production.
While some biopharmaceutical companies undertake this process themselves, others may outsource this process to a CDMO. CDMOs offer a variety of services along the pipeline of drug development, all designed to save your company time, resources, and budget.
From formulation development and clinical trials, all the way to quality assurance and product packaging, CDMOs can help your product reach its best potential to support patients across the globe.
So, what key factors should you consider when trying to find your perfect CDMO partner? Here’s our top nine questions to ask before making a choice.
What are Their Technical Expertise and Capabilities Like?
Look at the CDMO’s track record in your area of interest. Gather references from current clients, previous clients, and review platforms to assess their technical capabilities and expertise.
Do they have experience with similar proteins to yours? Have they conducted successful projects in your field? Do they meet current regulatory standards? Evaluate their expertise in process development to see if they can transform a lab process into a robust, scalable and compliant process.
For example, SEKISUI has been a global leader in the manufacturing of high-quality proteins and specialty biochemicals to the healthcare market for over 40 years, supplying superior materials for biotherapeutics, pharmaceuticals, and diagnostic medical devices. As experts in microbial fermentation, we understand the unique challenges of this field, and can support you every step of the way on complex projects.
How Do They Collaborate and Communicate?
A successful partnership between you and your CDMO partner needs open, effective communication and a collaborative approach towards your project. Transparency provided through regular updates along the project’s lifecycle will keep you in the loop and hitting your targets. Make appropriate use of your contacts and touchpoints within the different functional groups, including senior leadership of the CDMO.
In addition to this, make sure your CDMO partner values your input and fosters a collaborative relationship to boost outcomes and make you feel heard and understood. A CDMO partner who listens to you and creates a collaborative environment can significantly enhance project outcomes.
At SEKISUI, we pride ourselves on providing a flexible and responsive approach to all projects, involving regular review meetings to track progression and keep you updated.
How Do They Handle Scheduling and Scalability?
As with any venture, pharmaceutical projects may encounter unforeseen challenges and changes that have the potential to disrupt your project timelines and impact your outcomes.
We believe it is critical to ensure that you are able to make timely decisions to manage risks, which we do by creating detailed customised project plans to match your scope from the beginning. Having experienced project managers undertake feasibility assessments with you so you know exactly what’s happening from the start is key, helping you to avoid or resolve any potential challenges.
A CDMO partner with adaptable solutions and the ability to scale production is an invaluable asset should any challenges arise, so be sure to evaluate their ability to do this from the beginning. Do they have a risk management strategy? Can they scale projects according to changing demands or unique project needs?
The SEKISUI team always conduct a joint project review with clients at the end of each project phase to ensure that quality standards are maintained and that risk mitigation can be continually assessed and addressed. With our experience and focus on microbial expression and purification, you can trust your microbial project is in safe hands. We ensure there is adequate storage capacity and streamlined processing to save time and money for your project needs.
What is the CDMO’s Cost and Quality Like?
Consider the financial stability of the CDMO and make sure their pricing is transparent and aligns with your project’s budget. It is critical that they are willing to engage in honest discussions about pricing and cost breakdowns, and highlight any additional expenses that may occur, so your project is not met with any unexpected financial setbacks.
While cost is a crucial factor, don’t let it compromise quality or compliance. Here at SEKISUI, we believe adherence to regulatory requirements (whether it be the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or others) and quality standards (including certifications like current Good Manufacturing Practices [cGMP]) are non-negotiable in the pharmaceutical industry. We are proud to have cGMP productions as part of our range of services we offer.
Are They Willing to be Flexible?
Make sure that your CDMO partner can accommodate any specific requirements your project may have and customise accordingly. Discussing flexibility in processes, change management procedures, and the CDMO's willingness to adapt to unique project needs ahead of kick-off can save time later and keep your project running smoothly.
What Intellectual Property (IP) Protection Do They Have?
Before collaboration with your CDMO partner even begins, clear contractual agreements regarding IP rights should be established – protection of IP and confidential information is paramount in pharmaceutical collaborations.
Check that the CDMO has robust measures in place to safeguard your proprietary information and respect confidentiality agreements. SEKISUI’s experienced legal team will work with you to keep your information safe using secure cloud-based software for sharing all confidential documents.
How Do they Manage the Supply Chain?
Assess the CDMO's capabilities in managing the supply chain, including sourcing raw materials, inventory management, and global logistics to guarantee the timely delivery and distribution of biologics.
A partner with established supplier relationships and expertise in navigating global regulatory requirements, like SEKISUI, can ensure a seamless flow of materials and mitigate potential disruptions, minimizing any delays in production and distribution.
Do They Have Sustainability and Environmental Practices in Place?
Sustainability is a growing concern across all industries in today’s world, and pharma is no exception. CDMOs should assess their commitment to sustainable practices and how they manage environmental responsibility.
Choosing a CDMO that shares your commitment to sustainability not only benefits the environment, but also enhances your brand's reputation among environmentally conscious markets. At SEKISUI, we operate a zero emissions facility, so you can be assured your projects don’t generate a large carbon footprint. SEKISUI, a long-standing member of the Dow Jones Sustainability Index, has been consistently recognised as one of the Global 100 Most Sustainable Corporations in the World.
And Finally… Are They in it for the Long Haul?
If you pick the right CDMO, the likelihood is that this could become a long-term partnership.
Once a project phase is nearing its close, look for signs that your CDMO partner has the capability to support your programme needs for the next phase. SEKISUI offers post-project support, technology transfer, and lifecycle management. We also work with you to understand your project forecasts for the upcoming year to ensure we are best placed to support where required.
Knowing your CDMO partner values long-term relationships can contribute not only to the success of your current project, but the success of future ones too.
The Perfect Pairing for Your Business
Collaborating with a CDMO that shares your vision, values, and dedication to excellence can lead to fruitful partnerships, streamlined processes, and ultimately, the successful development and manufacturing of pharmaceutical products that positively impact global healthcare.
By defining your needs, assessing capabilities, ensuring regulatory compliance, having open communication, and considering long-term goals, you can identify a CDMO that meets your requirements and contributes to the success of your biopharmaceutical programme.
BioProduction by SEKISUI
Now you understand more about what to look for in a CDMO partner, why not explore what BioProduction by SEKISUI has to offer?
BioProduction by SEKISUI is a CDMO service with vast experience on projects at all stages, from pre-clinical to commercial. Our production team ensure a flexible and responsive approach to keep your project running smoothly, from the initial feasibility scope through to manufacturing.
Since our expertise is in microbial fermentation and downstream purification, we understand the unique requirements of projects using microbials over mammalian systems. You can be assured we understand the equipment and processes required for undertaking this kind of work.
With more than 100 products manufactured across plasmids, enzymes, and protein complexes, and over 40 years of manufacturing expertise in the UK, why not have the SEKISUI advantage?