Drug development is inherently risky. The high stakes associated with producing a lifesaving drug can weigh on a manufacturer. Every decision can make or break a project, and, unfortunately, many are made long before anyone knows if the drug will make it to market. This is compounded by the fact that so much of the work that goes into drug development is done in silos, weakening the potential for vital cross-functional communication and collaboration.
Parallel operations for speed to market
One solution to drug development challenges is adopting a parallel operations business model. This approach affords the opportunity to develop a process or to perform cGMP manufacturing in a parallel path using the resources of an external contract development and manufacturing organization (CDMO) while simultaneously establishing your manufacturing capabilities. In the end, you can mitigate the risks of drug development, reduce your capital costs, and get ahead of your competition by increasing your speed to market. This article provides several recommendations for how parallel operations can be leveraged in your biomanufacturing strategy.
1. Marry up your process and facility design
When it comes to expanding biomanufacturing capacity with a new manufacturing platform or facility, often two separate teams support those efforts. On one side, a group of experts focuses on the engineering perspective, heading up the facility design itself and overseeing capital costs. The other team performs process development, looking at the molecule and creating an effective, scalable formulation. These two teams are seldom married. Therefore, a facility or manufacturing train could end up being designed in a way that does not meet the technical needs of the project, setting up the company and the product for failure. This issue goes beyond just selecting the right bioreactors and chromatography columns; it also includes other important factors, such as knowing what the throughput of the facility should be, an appropriate size and footprint, and the number of people needed to support operations.
Working with an external CDMO process development (PD) team can help bridge the communication from PD to manufacturing by ensuring that your process can be optimized to the scale of your new facility. It can also help mitigate common tech transfer pitfalls that can occur. Using this business model, you can then bring that knowledge back in-house and transplant the process to your internal engineering group, ensuring a smooth handover of operations into your newly built facility.
If you have already designed a platform process and later found it did not meet your demand forecast, parallel processing can offer benefits retrospectively. While this may require additional capital investment, it is still useful to look at an existing process and identify what is not working to future-proof your facility design. An external CDMO can help you scale your process in real time so that you can quickly adjust your biomanufacturing strategy.
2. Keep the pace during capacity expansion
When speed to market is critical you want to avoid wasting valuable time in progressing your molecule to clinic. Outsourcing process steps to a partner who fills the gaps in your organization and enhances, rather than replaces, your internal expertise is critical. This type of collaboration strengthens your organization through a holistic approach that gives you the wide range of tools necessary to ultimately control your own manufacturing destiny.
If there are any reservations about maintaining a product’s titer and analytical comparability while preparing a new single-use or hybrid manufacturing facility, parallel processing can support proof-of-concept runs. This allows you to experience any anomalies that could occur during the developmental optimization or transfer work and then adjust your plan accordingly on a parallel path. Through a parallel operations business model, you could also consider outsourcing cGMP manufacturing with an external partner that is using the same equipment that will be installed in your facility. The process and knowledge can then be transplanted into your newly installed facility with minimum tech transfer issues. This will ensure a successful handover of operations back to your internal manufacturing team.
By considering these options, you can avoid having a facility sitting empty for several years while a product goes through clinical trials. CDMO services help you defer capital equipment costs until commercial manufacturing is ready to begin and the molecule can start generating revenue.
3. Seek help when entering a new or unknown market
The fierce competition driving speed to market is very palpable in the biosimilar arena. Taking advantage of the expired/expiring patents of some of pharma’s biggest blockbuster drugs means a new opportunity to cut drug costs for both manufacturers and consumers. However, any organization testing these waters faces considerable challenges, especially if they intend to target global markets. For example, developing a drug in China can become especially arduous when you are not familiar with the China Food and Drug Administration (CFDA) requirements for Phase 3 clinical trials. Specifically, the clinical trial application (CTA) lots for the product being pursued must be tested not just within China but also in the facility where the biosimilar would be manufactured. /p>
If you are entering this market for the first time, you face the prospect of building a new facility for your drug before you even conduct clinical trials. But what happens to your investment if the drug is not approved? And what would the biosimilar competition in China be like by the time your facility is finally built years later? These are just some of the questions you would need to consider if you take the risk of building a facility before you know the future of your drug. Rather than take these risks, there is the option to work with a local CDMO who has experience navigating these complex processes. They can help progress your molecule through clinic in parallel while you consider your long term biomanufacturing options.
Buy down the risks of drug development with parallel operations
Regardless of the type of molecule you pursue, the fear of the unknown can be one of the most crippling barriers a manufacturer faces. It is difficult to visualize the obstacles you might encounter over the average 12-year timeline it takes to bring a drug to market. Millions of dollars are invested in designing and validating a facility while there is still so much to be determined about the drug’s development process, such as throughput, molecule performance, and scale. If surprises down the road force you back into the design phase, it may require significant amounts of validation work for the facility, the utilities, and the equipment. The delays this work would cause could mean the difference between delivering an innovative first-to-market product or just another “me-too” drug.
Overall, delaying investment decisions until you know how your molecule will perform can help save significant dollars and avoid risk. Parallel processing gives you the option to work with a CDMO and delay the decision of which biomanufacturing solution might work best. This gives you time to choose from a variety of solutions depending on your demand forecast. In the end, collaboration with the right CDMO on a parallel path can ensure process security, transparency, intellectual property (IP) protection, and significant cost savings.
About Fast Trak Services
Cytiva has Fast Trak service centers in the USA, Sweden, India, South Korea and China and satellite Fast Trak Centers in Turkey, Japan and Singapore. The centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost and enable them to bring their product to market faster. Contact us for more information.