May 13, 2021 PAO-05-21-CL-04
At Avara Pharmaceutical Services’ OSD manufacturing facility in Arecibo, Puerto Rico, clinical and commercial OSD drug product manufacturing with integrated commercial packaging operations are provided for not only conventional OSD drugs, but potent compounds, Schedule II to V controlled drugs, targeted release formulations, tri-layer tablets, and advanced encapsulated products.
Avara was formed six years ago, and the Arecibo facility — which was acquired from Merck in 2015 — boasts many experienced and long-tenured staff members, with most having spent, on average, at least 15 years working in the pharmaceutical industry, including at both sponsor firms and contract service providers.
Our personnel have broad experience in pharmaceutical product transfers, commercialization, and the launch of OSD drug products, including in-depth knowledge and understanding of all applicable regulatory requirements to support all of our capabilities.
This extensive expertise, combined with minimal turnover, brings stability, continuity of knowledge, and experience to the long-term life cycle of Avara’s clients’ products. Their enthusiastic embrace of Avara’s commitment to customer service also ensures that we are able to apply a tailored and collaborative approach to our clients’ projects and ensure that their products are manufactured to high standards of quality, as well as any specification required.
Avara Arecibo, along with the other three Avara sites around the world, has implemented a global quality management system built upon current regulations, industry best practices, and feedback from regulatory and client audits. Our agile and efficient standard operating procedure (SOP) framework is underpinned by a quality management system (QMS) that ensures that all of our practices are compliant, common, and efficient.
In 2017, Avara Arecibo began implementing an updated quality culture based on data-driven thinking, risk management—including risk-based decision-making—and continuous improvement. The success of this effort has led to its implementation across all Avara sites. As a result of these efforts, Avara’s clients can expect the same positive experience, regardless of which Avara site they interact with.
The facility today has the capacity to produce three billion doses per year and is registered/authorized to sell products in 25 markets. Between 2015 and 2020, 17 inspections were conducted at the site by various agencies, including the U.S. FDA and DEA, FDA Philippines, PMDA Japan, AIFA, ANVISA, and the Russian, Taiwanese, and Peruvian health authorities, with all approvals/certifications granted. As recently as March 2021, Avara Arecibo achieved a successful outcome from an FDA GMP Inspection, with no Form 483s, further reiterating the high level of compliance at the facility. Similarly, 41 environmental regulatory inspections over the same period identified no fines or deficiencies and resulted in the granting of all necessary permits/certifications.
Puerto Rico offers Avara and our clients tremendous advantages. Ranked #32 out of 140 in the World Economic Forum’s Global Competitiveness Report for 2018 and projected to maintain that position through 2021, Puerto Rico hosts production sites for 12 out of the top pharmaceutical and biotech companies and 12 of the top 20 medical device companies.1 Technology companies, including Microsoft and Honeywell, have large operations on the island.
In Puerto Rico, high-technology industries like pharma also benefit from government incentives for further development. In addition, with such an extensive pharmaceutical and biotech presence, there is ample access to highly skilled and trained personnel. Furthermore, Avara Arecibo is a domestic U.S. site with oversight by U.S. FDA, EPA, and other domestic authorities. All of these factors contribute to the significant competitive advantage for Avara, with the benefits passed along to our clients.
The manufacturing, testing, and storage capabilities and controls in place at the Avara Arecibo facility to handle and produce Schedule II to V controlled substances have been inspected and approved by the U.S. Drug Enforcement Agency (DEA). The DEA-approved controlled substance capacity comprises 832 ft2 of the ~200,000 ft2 operational area at the site. We have two licenses, one for manufacturing (with quotas) and one for R&D (without quotas).
Avara Arecibo also has facilities for the processing of highly potent compounds to occupational exposure band (OEB) 5, including a high-shear module. This high-potency area supports the ongoing supply of key products to multiple geographies and has the potential for further investment and expansion to support even more products.
At the Avara Arecibo facility, most of our processes are highly automated. In the highly potent drug manufacturing area, for instance, because both operators and the environment must be protected, sampling is the only step managed by an operator. Everything else occurs within a closed system that is completely automated and leverages continuous processing. Performing all of the manufacturing stages electronically, with acceptance and certification by the regulatory authorities, is a real advantage for Avara Arecibo and our clients.
Our bi- and tri-layer tableting processes are also highly automated, enabling the consistent production of complex products that meet precise quality specifications for each tablet layer. Throughout the facility, we also have implemented advanced process analytical technologies (PAT), such as near-infrared (NIR) testing, for real-time monitoring of processes. The Avara Arecibo site is also the first Avara facility to implement electronic batch records with electronic signatures, which is invaluable for potent drug manufacturing. This technology is currently being implemented at all other Avara sites.
In essence, automation is a fundamental aspect of manufacturing operations at the Avara Arecibo facility, and these technologies allow us to achieve increased efficiency and productivity for our clients.
To enhance the services provided at the Avara Arecibo facility, a high-speed bottling filling line with a capacity of up to 30 million bottles per year was installed in 2020 with serialization to support the release of prescription products for international markets. In addition, we anticipate adding capabilities for aggregation in the near future.
Other recent investments include a process train involving blending, compression, and coating for a potential new COVID-19 treatment and a second process train in the design stage for another large-volume product.
Despite the challenges presented by COVID-19, we have been able to continue to meet our promise of manufacturing on time and in full at the Avara Arecibo facility The controls that we put in place to protect our employees allowed for continued safe operation and have enabled us to reach and maintain our customer service goals throughout the pandemic.
In 2017, Avara Arecibo began implementing an updated quality culture based on data-driven thinking, risk management — including risk-based decision-making — and continuous improvement.
With available capacity, a strong quality culture, recent capital investments, deep technical knowledge, and a lean, tailored, and flexible management style, the Avara Arecibo facility is ready to take on projects that require direct compression, encapsulation (gelatin and non-gelatin) of powders or granules, blending, and/or coating and also welcome clients with CBE 30 needs, including for controlled substances.
In addition to our main facility, which boasts over 248,000 square feet of operations, manufacturing, and warehouse space, there is another building at the Avara Arecibo site, already connected to utilities and in a pre-commissioned state, which has the potential to be customized to meet future needs for an additional 30,000-ft2 of GMP manufacturing. We also have a wealth of available land at the Avara Arecibo site for the construction of greenfield projects.
Recently, Avara Arecibo was delighted to welcome Juan Enrique Polanco, an experienced industry leader with over 21 years of experience in pharmaceutical manufacturing and packaging, to the role of Site Vice President. “One of our best assets is our people — they are a motivated, engaged, and client-oriented team with a continuous improvement mindset and are committed to creating strong relationships built on delivery, trust, and transparency,” Juan explained.“ As we move forward through 2021 and beyond, we are excited to welcome more clients to Avara Arecibo and to work together to build an efficient end-to-end supply chain for their products and to support their business objectives.”
Flor Rivera is a pharmaceutical and biotechnology leader with more than 30 years of quality/compliance and technical leadership experience. She is a proven leader in change management and the implementation of efficient quality cultures based on risk management and continuous improvement. She is also experienced in NDA/ANDA new and existing drug products transfer and market introduction. Prior to Avara, she worked with small and big molecules in public, private, and CMO pharmaceutical companies.