What are “3 Key Trends” shaping the CDMO industry in 2022 and beyond? August Bioservices’ Chief Commercial Officer, Joe Mase, shares his thoughts with Contract Pharma.

Increased Collaboration Between Sponsors and CDMOs

The first major trend we are seeing is the desire for deeper collaboration and better consulta-tion between innovator companies and their CDMO partners.

We know this—and have lived this first-hand—because the team at August Bio came from the innovator side of the business. We have decades of pharmaceutical development and commer-cialization expertise, having launched hundreds of branded and generic pharmaceutical prod-ucts into U.S. and global markets. During that time, we worked with a wide range of CDMOs around the world and found the customer service experience across providers to be uneven at best.

Addressing this service gap is a core reason why the leadership team came together to build August Bio–a U.S.-based, customer-centric CDMO that places a premium on proactive and stra-tegic project planning, coupled with responsive client service, and guided by nearly three dec-ades of sterile injectable fill/finish expertise.

The trend will continue to grow because the need is tangible. Pharma and biotech innovators realize they want CDMOs to be more than “an outsourcing vendor.” They want their CDMO to be equal parts expert advisor, scientific collaborator and technical operator.

Sponsors Wanting More “D” Capabilities from Their CDMOs

The second trend we are seeing, which is related to the first trend, is that pharma and biotech innovator companies are specifically looking for CDMOs that have robust, “capital D” drug de-velopment capabilities in house. More and more, the drug formulations we are seeing are be-coming increasingly complex as new, cutting-edge technologies are incorporated. As such, the interactions, behaviors and stability profiles of these compounds may or may not be well char-acterized by clients before they engage with August Bio.

Going from bench scale to batch scale can be a challenge for any company, but it can be par-ticularly difficult for smaller, mid-size or virtual companies that don’t have the resident formu-lation and scale up experience to tackle those challenges themselves. This is precisely where CDMOs like August that have a team of in-house drug development experts can help. We take a risk-based, data-driven approach, with an eye towards optimizing the optionality of a com-pound’s development pathway.

As an end-to-end solutions provider—from research and development to laboratory testing ser-vices to manufacturing all under one roof—August’s integrated teams work together in person and side by side to develop formulations and conduct analytical investigations at the same site. This real time collaboration yields significant efficiency gains for clients.

Domestic and Global Sponsors Still Are Looking for US-Based CDMOs

The third trend we are seeing began with the onset of the COVID-19 pandemic in March 2020. Both domestically based (US) innovators as well as global sponsors of drug development, testing and manufacturing projects, continue to seek CDMO partners based in the U.S.

The reasons for desiring a U.S.-based CDMO are well understood. First, the U.S. remains the largest and most lucrative pharmaceutical market in the world. Second, because of this, pharma and biotech companies worldwide would like to get their drug candidates into clinics in the U.S. market with the goal of achieving FDA approval.

What the pandemic brought to light for the world to see was the actual dearth of available manufacturing capacity in the U.S. The problem was exacerbated when COVID-19 vaccine production consumed much of the available manufacturing capacity, sending pharma and biotech innovator companies scrambling to find CDMO providers who could fill and finish their products within their timelines.

In the process, pharma and biotech companies both large and small have discovered highly capable and highly flexible CDMO partners like August Bioservices, that not only could meet their manufacturing timelines but could also deliver exceptional service along the way.

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August Bioservices is a US-based CDMO, strongly focused on sterile injectable formulation and fill/finish cGMP manufacturing—optimizing liquid and lyo products, aseptic or terminally sterilized—at both clinical and commercial scale. August also offers end-to-end analytical testing and support services including extractables and leachables.