Demand for outsourcing microbial manufacturing has increased dramatically in recent years and will doubtlessly continue as novel drugs are more rapidly discovered. Due to our long history in drug development, we understand the significance of choosing the right microbial CDMO and the long-term impact on companies that choose incorrectly. In the face of an ever-growing pool of service providers, understanding the key factors that will enable your molecule to move from development to market is critical. When looking for a microbial CDMO partner, we recommend you focus on these six key attributes to help ensure your product’s success.
1. Overall Capabilities and Capacities
Companies often focus on project cost and timelines as the driving factors when choosing a CDMO. A more important aspect to consider before entrusting your product to a new partner is if they have the technical capabilities and capacity to ensure a high-quality and safe final product that makes the most of your investment. It is non-negotiable that they work from modern facilities designed to meet international regulatory requirements, and strategically located to allow for efficient logistics and supply chain needs. As the pace and efficacy of drug discovery increases, it is also crucial that your CDMO partner have both a large, experienced workforce and the ability to physically expand manufacturing capacity in order to support additional industry demand.
2. Wide Breadth of Experience in Microbial Production Processes
Microbial production is a complicated process. Due to the diverse pipeline of microbial molecules, there is no single affinity capture step for purification which often leads to more complex downstream processing. Additionally, there are numerous other factors that require scalable engineered solutions to overcome solubility, purification, and refolding hurdles. Because of this, the ability to create a platform process, like with mammalian production, is off the table. To meet the complex needs of your microbial product, your CDMO should be well-versed in more than just E. coli since multiple types of yeast and bacteria strains are utilized as efficient production platforms across the industry.
3. Trusted Reputation
Go to any conference or Research Triangle coffee shop and you will see that word-of-mouth is a driving factor in what service providers are chosen. An essential indication in determining whether a manufacturing partner is capable of successfully completing your project at the quality and scale required is their meaningful relationships and industry reputation. Having varied, verifiable experience in a range of modalities, production processes, and manufacturing scales is a large advantage. And, as patient safety should always be top of mind, excellent regulatory compliance and a strong audit track record are necessities. Years of experience, responsive service, and high success rates will help to ensure that you can depend on a CDMO partner’s technical knowledge to deliver your molecule to market.
4. Flexibility to Customize Processes
Nothing is guaranteed in life or microbial manufacturing. Every project is bound to encounter obstacles and challenges, so it is vital that your chosen microbial CDMO be resourceful and able to provide creative problem-solving at every stage. Whether it is addressing complex product needs or difficult challenges that arise, they should have the flexibility to explore all solutions and customize the process to your unique project. This requires having a range of equipment types from small-scale R&D to large commercial scale, offering single-use or stainless-steel reactors, and utilizing equipment with adjustable settings to control different aspects of the process.
5. Established Quality Systems
At every scale-up, quality is paramount to the success of your product. To ensure procedural and operational excellence across all parts of the process, a time-tested quality management program in place is key. Your microbial CDMO should have rigorous, multifaceted quality systems involving QA, QC, validation, compliance, and document control to warrant product safety and batch-to-batch consistency. Being safety-focused and using early-stage analytical insights to proactively overcome challenges reduces risk and gets your project over the goal line.
6. Excellent Customer Service
For microbial manufacturing, partnering with a CDMO should be a long-term experience as the ultimate goal is to overcome your molecule’s complexities together and continue to meet future clinical and commercial supply demands. Constant program management is necessary to identify timeline risks, provide solutions at decision points, and work in step with you for safe and stress-free delivery of the final product. In order to build a trusted relationship, choosing a partner that is responsible, reliable, and resourceful when it comes to your needs is critical to advance your molecule to market.
At Cytovance Biologics, we work to exemplify these six key attributes in our comprehensive approach to microbial manufacturing. We put our Culture of Ingenuity first in order to meet modern challenges and provide the industry with the high-touch customer care that they deserve. Our team has experience successfully leveraging strains across a portfolio of e. coli, Pichia pastoris, and Saccharomyces cerevisiae from our modern facility in Oklahoma. Our facilities feature the latest assets including the Sartorius Ambr® 250 system, a high throughput, automated bioreactor system for process development, and the Thermo Fisher Impulse Mixer for low shear mixing. By partnering with us, you will receive all of the technical capabilities, expertise, flexibility, and reputation needed to drive your product to success.
A three-minute investment could make all the difference for your microbial molecule! Hear from our experts themselves on why we are the right choice to guide your program to its next milestone here.
- Interested in complex microbial molecules? Watch our “Downstream Process Development of a Complicated Fusion Protein” webinar.
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