What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? August Bioservices’ vice president of operations, Jason Hartman, shares his thoughts with Contract Pharma.

Specialized formulation capabilities – e.g., LNPs (lipid nanoparticles)
Increasingly we are seeing customers that are looking for specialized formulation capabilities and, specifically, expertise in developing lipid nanoparticles. August Bio can work with a range of LNP formulation and sizing technologies to achieve the desired product profile. Through thin-film deposition and rehydration or working with suppliers to develop custom jet mixing/solvent injection systems, we can design high-throughput processes that generate lipid nanoparticles for further processing. Downstream capabilities for high-shear mixing, high pressure homogenization and microfluidization can be configured to develop robust, reproducible manufacturing processes in R&D studies and then scaled to GMP for both clinical and commercial applications.

We couple this with analytical services ranging from dynamic light scattering for particle sizing, to LC/LC-MS/GC-FID/LC-CAD for lipid assays and residual solvent quantification. This allows August Bio to offer an end-to-end turn-key approach to product life cycle development starting at LNP process development and product characterization, moving through early GMP and eventually to commercial scale operations.

Most importantly, August Bio offers a dedicated team of development and technology transfer professionals with deep subject matter expertise. The tools combined with the team allow for an integrated and collaborative approach to R&D.

The need for capacity at the right scale for the size of the project
Going from bench scale to batch scale—or small batch scale to large batch scale—can be a challenge for any company, but it can be particularly difficult for smaller, mid-size or virtual companies that don’t have the resident formulation and scale up experience to tackle those challenges themselves. Moreover, finding a CDMO that has the right scale of capacity available at the right time, i.e., within the customer’s forecasted project timelines, can add an extra layer of scheduling complexity.

This is precisely where CDMOs like August Bio can help. Because we’ve recently finished an extensive facility renovation that has added multiple filling lines, new clean rooms, additional formulation suites and numerous supporting technologies (including terminal sterilization and lyophilization), we believe August Bio is uniquely positioned to serve clients at every scale in 2023 and beyond. August Bio has lab scale, small- to medium-, and large-scale filling lines that allow for development that can be easily scaled up. We also can support unique container sizes on our fill/finish lines, including up to 500 ml vials/bottles, up to 50 ml PFS and cartridges, and IV bags up to 2 liters.

Customers have expressed interest in partnering with CDMOs that can meet their current needs as well as their future needs. Identifying a scalable, qualified, and responsive long-term partner is critical to customers as they plan their projects.
As an end-to-end solutions provider—from research and development to laboratory testing services to manufacturing capacity all under one roof—August Bio can be the “one stop growth shop” CDMO they’ve been hoping to find. 

Close collaboration with customers
Many on the leadership team at August Bio have been on the innovator side developing novel drugs and high-value generics, which provides insight into the challenges that our clients face. We’ve been the individuals and teams responsible for researching, vetting, and hiring CDMO partners.

When we established August Bio in 2020, we did through the lens of the customer and created the CDMO we always wished we could’ve hired—with deep expertise and operational focus, state-of-the-art systems and equipment, and, most of all, collaborative, solutions-oriented project teams.

What we see more and more are customers that are looking for collaborative CDMO partners that serve as a true extension of their project teams. From the selection of containers and materials to visibility into production, testing and the supply chain, customers consistently tell us the most valuable partners are also the most transparent.