The global biomanufacturing market is expected to reach $43 billion in the next decade as large-scale manufacturing for biotech and pharma products remains a critical aspect of delivering life-changing medicines. The ability to get a manufacturing site up-and-running quickly and efficiently is vital to companies that want to remain competitive.
Our team at Rubius Therapeutics was able to revamp and operationalize a new manufacturing site for an investigational therapy that had never been manufactured in a cGMP environment in record time — one year ahead of schedule — at our site in Smithfield, Rhode Island. Here are some of the key lessons we learned.
Location and talent
When choosing a manufacturing site location, it’s important to consider current and future physical space needs. Once the optimal footprint is selected, it comes down to location. Identifying areas that can fuel growth in the short term and allow scalable manufacturing capabilities to be developed over time will ensure success in the long term. Proximity to your company’s development team is also important — interaction and collaboration between development and manufacturing teams is key, particularly when establishing an entirely new platform.
When choosing a site, companies should consider not only the local life sciences ecosystem, but also manufacturing expertise within the state. The best locations will supply support from all types of partners, from complementary companies to local officials. A connected local business community provides partners for infrastructure development, enhancements to the supply chain and other essential business functions.
Following the acquisition of our Smithfield facility, we engaged several organizations to lead the renovation and build on a two-year timeline. Efficiencies on the part of all parties involved, including local partners, led to a completed build out nearly a year early, which underscores that choosing the right partners can lead to success.
When manufacturing new or complex therapeutics, the right kind of workforce is also critical.
Rhode Island proved an ideal location with access to existing high-caliber talent across the Providence region. Local workforce development programs, such as RI BIO’s Leadership and Development program and the RI Chamber of Commerce’s Wavemaker Fellowship, provide public-private partnerships that give companies the ability to train and attract employees in a way that fits business needs. The right mix of talent factors allows for team growth at a fast pace — our team in Smithfield grew from three to 71 employees in less than 18 months.
Company-owned manufacturing operations is an emerging trend, and one that is being driven in large part to offset observed risks of externalizing manufacturing. For our company, owning the facility allows us to quickly advance new updates to our platform from concept to product supply, and rapidly deploy our products. It also enables process robustness through simplified operations while providing immediate operational cost savings.
Minimize supply chain risks
Competition for raw materials will continue and companies will need to think strategically in developing and implementing secondary sourcing plans. Some may need to carry significant inventory to minimize stock-out risk. Developing a business continuity plan early will help companies prepare for risks and enable a quick response to changes in the operating environment.
As the COVID-19 pandemic emerged, our company procured safety stocks of approximately six to nine months, and longer in some cases, for all of our manufacturing materials. In doing so, we did not see a disruption in our manufacturing operations or the ability to supply drugs for our ongoing clinical trials. Developing a robust plan will continue to be critical to any company’s collective success — even in a post-pandemic environment.
As the global biomanufacturing market grows, companies will need the right approach to successfully operate new and existing manufacturing sites and deliver value to patients. Designing and establishing robust business processes to remain steadfast, even in the face of challenging and unexpected situations, will be paramount to success.
