Drug development is inherently risky. Every decision can make or break a project. Having a parallel operations business model can help spread the risk by performing biomanufacturing in a parallel path using CDMO resources.
A parallel operations approach affords the opportunity to develop a process or to perform cGMP manufacturing in a parallel path using the resources of an external biologics contract development and manufacturing organization (CDMO) while simultaneously establishing your biomanufacturing capabilities. Here are 3 opportunities where parallel operations with a CDMO can be leveraged to reduce risk while accelerating speed to market.
1. Marry up your bioprocess and facility design
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. Using this business model, you can bring knowledge from a CDMO 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. 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 biomanufacturing capacity expansion
When speed to market is critical you want to avoid wasting valuable time while 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. You could also consider outsourcing cGMP biomanufacturing with an external partner that is using the same equipment that will be installed in your facility. The process and expertise can then be transplanted into your newly installed facility with minimum tech transfer issues. This type of collaboration strengthens your organization and avoids having a facility sitting empty for several years while a product goes through clinical trials.
3. Seek expertise when entering a new or unknown market
The fierce competition driving speed to market is very palpable in the biosimilar arena. 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. 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 biologic 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 biomanufacturing facility before you know the future of your molecule. 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.
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.