DMOs are playing increasingly important roles in providing knowledge, expertise, and capacity in breakthrough areas of healthcare. While manufacturing for mature sectors has become standardized — even commoditized — product innovators value access to specialized CDMOs with experience and capacity in novel sectors, such as antibody–drug conjugates, cell and gene therapies, and live biopharmaceutical products (LBPs).
A significant fraction of the pharmaceutical and biopharmaceutical pipeline resides in smaller companies who typically do not possess the infrastructure and organization needed to produce clinical products through to licensure and want to partner with CDMOs. Even large organizations are hesitant to invest in novel sectors until they are confident that there is a path to the market and will partner with CDMOs even if they pursue a hybrid model with internal manufacturing plans. This model of reliance on CDMOs as development partners, especially for novel technologies, is likely to continue over the next decade.
Arranta Bio has more than 10 years of experience in manufacturing challenging LBPs that meet the yield and viability characteristics that clients seek, including species that clients may be skeptical about being able to produce. We have undertaken several proof-of-concept studies to demonstrate that our proprietary manufacturing platform — with custom formulations for culture media and cryopreservatives — can achieve a client’s critical product attributes. Arranta Bio has also focused on long-term partnerships to support clients from preclinical work through product approval, launch, and commercial supply, investing $100M in capacity and building the organizational depth needed for this journey.
We support U.S., EU, and Asian customers at our early clinical facility in Gainesville, FL, and our late clinical and commercial supply facility in Watertown, MA. We operate as part of a global supply chain for materials, consumables, and products, and are always open to partnering where there is a technology or capability that would serve clients better.
We communicate effectively with clients anywhere on the globe and host virtual site tours and quality audits when clients cannot travel. We are conscious of our supply chain — equipment, consumables, and materials are sourced from many locations and, in some cases, there is a limited choice about where items can be sourced. This necessitates careful consideration of safety stocks, lead times, and alternative sources, especially since supply disruptions can have a significant impact.
The COVID-19 pandemic has prompted us to be more open to work-from-home situations. We have also tested shift work for less traditional roles, such as in process development, and explored the communication needs that this creates. The level of communication made possible through virtual town halls, lunch and learns, and other initiatives has been greatly enhanced, and we will maintain a higher frequency of shorter meetings in the future to support employee engagement and alignment.
Arranta Bio’s goal is to be the leader in our sector. We are achieving this through a combination of experience making LBPs, a leadership team that is applying the experience of obtaining license approvals for many biologic products at innovator and contract manufacturing companies, and the financial support of our investors to make bold moves to create the capacity to serve this sector ahead of the demand curve.
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