Avéma Pharma Solutions
Turnkey Solutions for Accelerating Commercial Production

Pharma and biotech companies are increasingly utilizing Contract Development and Manufacturing Organizations (CDMOs) as extensions of their development and manufacturing departments. In fact, the COVID-19 pandemic increased the number of international companies interested in partnering with US-based CDMOs, because so many active pharmaceutical ingredients and raw materials are outsourced from outside the country, leaving the supply chain vulnerable to disruption. Offering unique synergy between R&D development and commercial manufacturing, Avéma Pharma Solutions, a division of PL developments, provides integrated, turnkey, end-to end solutions for liquid and solid dose Rx and OTC products—from concept to product development to commercialization, all the way through FDA approvals. With a unique focus on small batches and short turnaround times, Avéma’s method can allow for more characterization of the process to support the FDA’s mandate on quality by design and can help reduce FDA review time.

“Avéma’s streamlined approach helps companies accelerate R&D and efficiently transfer to commercial production, bringing products to market more quickly and cost effectively,” says Dana Toops, President of Avéma Pharma Solutions. “We often cut four to eight weeks out of traditional timelines,” he adds. Avéma is able to reduce time to market by starting each project with DOE techniques that identify the critical quality attributes of a product, developing a robust formulation, and then establishing a process design centered around those attributes. To ensure the seamless transition from pilot manufacturing, Avéma uses small-scale production equipment in the development process that has identical specifications to what will be used in full-scale commercial manufacturing, rather than bench top or pilot manufacturing equipment, all under the supervision of a single project manager to ensure that no information is lost during scale up.

As a mid-sized CDMO, Avéma focuses on personal service. “Every customer is a priority for us,” says Toops.

“Our goal is to make it easy for customers to work with Avéma, by responding quickly to customer needs, communicating clearly and assuring the success of every project.” To better support its customers, Avéma offers an ever-growing portfolio of formulations and is committed to investing in the equipment and capabilities need to assure the success of a project, such as granulation, drying, coding capabilities and compression. The company also recently expanded its liquid capabilities. “We evaluate each project and make sure that we have the capability to execute the project successfully in a timely manner,” adds Toops. When one of Avéma’s clients required tray drying capability, the company procured, installed and operated the required equipment for tray drying within a six-week timeframe.

Maintaining long-term relationships with clients is a priority for Avéma and consequently each opportunity is carefully evaluated based on the company’s expertise, resources, and ability to meet timelines. Avéma’s core values and effective quality system are ingrained in day-to-day operations.

“The desire to build the brand organically brings confidence and continuity over the life a client relationship,” says Toops. Avéma adheres to a disciplined approach to execution that is rooted in the company’s strong culture of quality, responsibility and innovation. The team establishes firm targets for all project activities and draws on decades of experience to address any issues that arise before they become problems. This approach establishes a high level of trust among customers, knowing time is critical to successfully launching products. Moving forward, Avéma is evaluating options to expand both its human capital and assets to support the anticipated demand for U.S. based manufacturers. Taking advantage of a leadership team with over two decades of experience alongside cGMP-compliant and FDA-registered facilities, Avéma delivers the highest level of service from initial R&D to clinical trials to full-scale commercial production.