Based in Norman, OK, Avara Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) with facilities in North America and Europe.

Avara has a solid base of oral solid dosage (OSD) and sterile manufacturing and packaging expertise that includes four state-of-the-art facilities delivering two billion patient doses annually. Its capabilities in OSD manufacturing and packaging are located in Aiken, SC; Arecibo, Puerto Rico; and Norman, OK, while sterile operations are run out of Liscate, Italy.

Avara’s chief executive officer, Larry Lee, recently shared some of his thoughts about the company’s push to bolster its oral solids and steriles business operations. He talks about trends in both markets with Contract Pharma, and highlights some of the CDMOs recent advances.

Contract Pharma (CP): Since taking the helm at Avara, how has the company evolved? What accomplishment are you most proud of and what has been unique during your tenure compared to previous pharma roles?

Larry Lee: I transitioned into the role of CEO in October 2019, after an extensive career within the Avara and Astellas organizations (Avara’s corporate HQ in Norman, OK is a legacy Astellas site). During my 25 years at this facility, I’ve held leadership positions in a wide variety of departments including Quality, IT, and Business Transformation. In 2019, Avara made the decision to refocus our business on our oral solid dose and sterile manufacturing and packaging services. I am extremely proud of our entire team for their loyalty to the organization during these changes, as well as for their unwavering commitment to maintaining ongoing product supply and quality for our clients and, in turn, the patients we serve. As an organization, we delivered two billion doses last year, and our EBITDA was $30.1 million (unaudited) on $203 million revenue.

CP: What are some of Avara’s most recent business highlights?

Lee: Avara has refocused to leverage our core capabilities and expertise in oral solid dose, sterile manufacturing, and packaging in order to deliver reliable outsourcing. Our four state-of the art facilities—located in Aiken, SC; Arecibo, Puerto Rico; Liscate, Italy; and Norman, OK combine to deliver approximately 2 billion doses annually to over 40 countries. In order to continue to build on that solid base, significant investments have been made to expand capabilities and capacity in all areas.

In Aiken, SC; Arecibo, Puerto Rico; and Norman, OK—where our capabilities in OSD manufacturing and packaging are located—multiple investments have been made to expand capabilities and capacity. New manufacturing equipment installations include: a thermal oxidizer; a hot melt extrusion system; fluid bed granulator upgrades; bi-/tri-layer tablet and chilled tablet presses; and an additional encapsulation machine. In terms of packaging, new lines for bottle packaging and cartoning have been added, along with robotic case packers and palletizers. In addition to the equipment introductions, facility enhancements to enable high potency product containment and DEA Schedule II and III products have been instituted within Avara’s OSD network. Finally, future investments are underway to increase capacity in tablet manufacturing, specifically with additional blending, granulation, compression, coating and tablet printing capabilities.

CP: In which area(s) is Avara observing the greatest growth from clients, and in which geographies are these firms based?

Lee: As we’ve shifted our focus to steriles and OSD we have seen increased growth in those areas. Throughout 2019, we saw significantly increased demands in OSD manufacturing on several products already being produced in Norman and Aiken; and our Arecibo facility is planning for even higher volumes in 2020. In addition, these OSD facilities are supporting a variety of technical transfers of new products. In Liscate, our steriles facility has seen increased volumes resulting from clients placing new lyophilized and liquid vial filling business with us. These products continue to move through tech transfer and commercial supply. In terms of geography, our clients are based across North America, Europe, and Asia-Pacific.  

CP: What are some of the crucial issues impacting pharma manufacturing and supply and CDMOs in particular?

Lee: Along with many others, we have been recently challenged as an industry with the coronavirus (Covid-19) pandemic and have had to face the challenge of maintaining continuity of supply for our clients and the patients in the markets that we serve. During this time, Avara has maintained close communications with local authorities to ensure we are aware of and in compliance with the latest recommendations, balancing the safety and well-being of our employees with working to protect supply. 

More broadly the key issues impacting manufacturing include: maintaining robust supply chains in CDMOs for raw materials and supplies, while closely managing spending to ensure we can meet target pricing for clients as well as required business objectives; providing sophisticated capacity management in order to support multiple products through the facilities while monitoring the changing demands of supplies; and maintaining flexibility of services to meet the wide range of expectations of our broad client base.


CP: Describe the state of the oral solid dose manufacturing market?

Lee: We continue to see significant demand for OSD manufacturing and integrated packaging services. From our perspective, key drivers for clients placing OSD business include:

• Consistency of supply and quality—Trusting that their manufacturing partner understands their key deliverables and supply demand, and always delivers with full compliance to all regulatory standards;
• Price—Trusting that they will receive fair pricing and contractual terms; and
• Technologies—Trusting that their partner is willing and able to utilize technical expertise and apply appropriate technologies in order to deliver manufacturing and supply solutions in keeping with the complexity of the manufacturing process of a given project.

CP: What are some trends in today’s oral solids market to keep an eye on?

Lee: At Avara, we are proud to have three OSD facilities located across the U.S. and in Puerto Rico, all of which have a strong history of supplying oral solid drugs—including blockbuster Rx and OTC products—to the market for decades. In order to support both client requirements and industry trends, we have been continually investing in these facilities. Because of these investments, we are confident that we are well positioned to support our existing and new clients’ needs now and in the future.

One area in which we’ve seen a rising trend is in patient-centric dosage forms. At our Norman, OK, facility—which has extensive, demonstrated experience in spray-drying technologies, as well as recently-added encapsulation capabilities—we are ready to support client needs with technical advice. Also, at our Aiken facility in South Carolina, we are expanding our capacity for blending, granulation, compression and tablet coating.

Additionally, we have been observing and monitoring the market dynamics relating to opioid products, particularly in the U.S. We have controlled substance capabilities at our Arecibo site and have invested approximately $11 million in the last two years to add to their existing ability to handle highly potent compounds and advanced formulations, therefore increasing capacity for development and clinical scale work. In addition, Arecibo has also benefited from a recent investment into high-speed bottling, a reverse thermal oxidizer, and the ability to handle tri-layer tablets. 

Finally, as an organization, we are also seeing higher volumes of requests for CBE30 timelines to speed products to market. At Avara we prioritize attentiveness to product goals and excel at working in collaboration with clients to build the timelines necessary to achieve accelerated product goals.  

CP: How is delivery technology for oral solids advancing?

Lee: Recent market advances have been made by companies offering orally dispersible tablets to support dosing. Avara has the technology to manage these types of drug presentations within our Aiken facility. Poor solubility products can be handled with our hot melt extrusion capabilities in this facility, as well. Finally, this facility has recently invested in enhancing its tablet printing capabilities.

Additionally, controlled release formulations, commercial spray drying to improve bioavailability and solubility and roller compaction for better process control within dry granulation, are all areas where the industry has moved forward and Avara is positioned to support all these technologies. Multi-product doses in the form of bi- and tri-layer tablets is another area in which we see the market growing and our facilities in Arecibo and Norman both have service offerings to support this.

CP: On the sterile injectable front, what trends/challenges are having an impact on the market and Avara’s business in particular?

Lee: Since acquiring our steriles facility in Liscate, Italy, Avara has seen significant demands for the services offered by the site there. Our sterile capabilities include lyophilized and liquid fill vials and ampoules, offers scale up from pilot to commercial, and has capabilities to handle potent compounds. Avara Liscate’s operations have been running for 50 years, with a strong legacy of delivering commercial scale supplies to market for large pharma companies, in a contracting capacity, for almost 20 years.

The Covid-19 pandemic has brought great challenges to our business, as it did for the whole pharmaceutical industry. Despite these challenges, across our facilities, we continued delivering supplies to market in line with our client’s needs. As an organization, we are especially proud of our Liscate employees, who continued to manufacture and supply vital medication for use in critical care patients during unprecedented times and under long-term restrictions. 

CP: How do you see the steriles market evolving over the next 5 years?

Lee: We anticipate that the market for pre-filled syringe dosing presentations will continue to grow and the biologics sector will also continue to expand. We also believe that the Covid-19 pandemic will lead pharma companies to evaluate their entire supply chains, particularly regarding drugs supporting intensive care and oncology therapies. Our expectation is that this will bring API sources for sterile products closer to the regions in which the sterile drug manufacturing facility is located. Ultimately, we see the industry moving towards securing robust supply chains for these critical products.

CP: What is next for Avara?

Lee: At Avara, our network is focused on the oral solid dose and sterile service offerings and in providing an attentive and nimble service to our clients. As we continue to invest in our existing facilities and people, we are focused on organically growing revenues across our network. We are also considering potential acquisitions where they complement our existing services, either across geographies or where they expand our OSD and sterile offerings and following robust due diligence assessments.

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Larry P. Lee is the CEO of Avara Pharmaceutical Services and has over 25 years of experience in the pharmaceutical industry. He is responsible for Avara’s global manufacturing facilities and is actively involved in system integrations as well as creating added value across Avara’s sites and continents with a strong focus on operational excellence within all facets of solid dose manufacturing and packaging capabilities. Larry has held various management positions in the laboratories, quality assurance, and information technologies in the pharmaceutical manufacturing space. He has been heavily involved in leading global initiatives for multiple pharmaceutical companies, including Avara, and is skilled at managing complex teams under the regulatory authority of Europe, Japan, and the U.S. Larry holds a Bachelor of Science degree in Biological Sciences from Oklahoma State University.