Manufacturing at the right scale
Selecting the appropriate manufacturing scale to satisfy your process yield and titer and product demand is key to ensure that your product demand at launch and beyond is well-served and to balance the cost of goods as your program prepares to launch.
We are experienced in helping you select the optimal scale for your product so that you can launch with confidence and balance your priorities. We work with you to provide flexibility and we are able to support multiple types of processes and product market demands while considering and optimizing the time to market for your next drug candidate.
As the biopharma industry witnesses a shift to niche therapies, greater market fragmentation and enhanced process efficiency, the need for a variety of manufacturing scale options increases. Concurrently, drug development timelines are being shortened driven by technical progress in R&D, changes in the regulatory landscape, e.g. breakthrough and fast track approvals, as well as the imperative of bringing therapies to patients quickly. Today’s market is seeing more complexity in proteins being developed, leading to more tailored production needs.
More than ever, it is essential to find a supply solution that helps manage forecast and demand uncertainty, while also optimizing launch costs.
To respond to the market need of flexibility between small and large volume requirements and help you accelerate time to market while simultaneously controlling your investment risks.
A number of developments as those mentioned above are translating into a growing demand for mid-scale manufacturing among pharmaceutical and biotech firms. Fragmenting of patient populations through either targeted therapies, more personalized treatment protocols or competing products including biosimilars may require capacities lower than would have been the case in previous years. In addition, the number of therapies addressing unmet needs for niche or orphan indications is increasing, fueled by supportive regulatory systems and buoyant biotech funding. Increased potency of biologic molecules together with more efficient bioprocessing including higher titers and yields are also factors driving the need for mid-scale capacity.
Meeting in the middle
To date, the industry has focused on two key areas:
- Large scale capacity (>10,000L) supporting large volume supply at the best cost of goods possible
- Small scale capacity (< 5000L), increasingly in single-use technologies, offering speed from the clinic to commercial at reduced investment costs
Mid-scale capacity (5,000 – 10,000L) offers a blend of these two sizes, while improving the costs of goods anticipated from small scale or multiplexing and decreasing the investment required for a larger scale launch.
We have invested in a new 6,000L mammalian manufacturing facility to meet the aforementioned market trends, product and process requirements. This new mid-scale capacity complements existing small- and large-scale manufacturing.
Simplified scale-up and multiple go-to-market strategies
To ease scale-up from small scale and tech transfer from single-use technology, the plant will use single-use technologies in the seed reactors. Stainless-steel bioreactors will be used for production in the upstream but single-use in the downstream. This hybrid model leverages the best of both technologies and brings benefits in cost and speed.
We will work closely with you to identify when is the right moment to scale-up depending on your process and forecast strategy.
An under-sized initial launch scale can result in a shortage of supply to patients and lead to possibly significant loss of market share and lost revenue. Conversely, over-sizing launch scale can result in under-absorbed upfront costs and supply chain risks inherent in hyper-focused production strategy.
Risk mitigation through scalable manufacturing solutions is critical for rapidly moving early phase clinical to late stage clinical and commercialization. Given market uncertainty, having access to multiple go-to-market strategies is also important to help mitigate the risks of under-sizing or over-sizing production scale. This is why we offer a platform approach with facilities from 1,000 to 20,000 L and experience across multiple scales and processes.
Innovation in manufacturing to match next-generation molecules
The increasing diversity in molecular formats and titers translates into a multitude of downstream processes, each optimized for a particular molecule. This complexity can prove problematic in a traditional stainless steel facility for any company or CDMO dealing with a range of products. We have spent a considerable amount of time designing our new facility to be able to deliver a new wave of more complex antibody formats. The solution has come in the form of a hybrid facility that combines the cost efficiencies of 6,000L stainless steel bioreactors with disposable downstream technology that allows for a plug and play approach depending on the process needed.
Automation to increase transparency and improve confidence of delivery
We have designed our new mid-scale facility to include automation and process analytic technology. These open up the possibilities for real time data sharing and transparency allowing our facilities to become an extension of your own assets. You could consequently check how your product is performing from your laptop whether you are in the office or at home. With this unique level of transparency, we are creating an open platform that enables global business and a more integrated partnership.
Machine learning and predictive analytics integrated in the facility design also provide enhanced quality controls and greater efficiencies.Try our Drug Substance Manufacturing Scale Tool to explore flexibility and support for multiple types of processes and product demand: