Meeting the Needs of the Evolving Sterile Injectables Market

Meeting the Needs of the Evolving Sterile Injectables Market

June 16, 2022PAO-06-022-CL-06

The pandemic has significantly affected the pharmaceutical industry, including the contract manufacturing segment. CMOs with flexibility, agility, and speed combined with the ability to form strategic partnerships have been best positioned to support customers going forward. Avara’s Liscate sterile injectables facility has these attributes and continues to pursue investments in equipment and technology — including digitalization solutions for documentation, remote auditing, training, and more — and is exploring the introduction of development capabilities to enhance its ability to support customers from late-stage clinical trials through commercialization.

Pandemic Impacts

As with most sectors within the pharmaceutical industry, contract manufacturing has been strongly impacted by the COVID-19 pandemic. These impacts have been significant, even unprecedented, and many of the changes that have evolved will remain even after we move on from the pandemic.

One of the biggest changes to this segment of the industry was the transition from steadier market demand to a situation characterized by spikes and troughs as the world responded to waves of infections caused by new variants of the SARS-CoV-2 virus. This dynamic and unpredictable situation was challenging for everyone, including contract manufacturers, to manage. Procurement difficulties and significantly extended lead times heightened these challenges.

Customers have responded by seeking to reduce the number of contract manufacturing partners with whom they work, as well as to form deeper and more strategic relationships that are better positioned to respond to such challenges. Meanwhile, lockdowns and limited travel within and across borders created the need for digital solutions to facilitate internal and external communications — from personnel training and remote work to sales and marketing efforts to auditing and inspections. The advent of mRNA vaccines, meanwhile, reflects a general trend in sterile injectables toward more personalized products.

Those companies that were sufficiently flexible and agile to survive the COVID-19 pandemic did so in part because they rapidly adopted new ways of communicating with their stakeholders — employees, suppliers, customers, and regulators.

Importance of Speed, Flexibility, and Agility

The sudden changes in demand that occurred during the COVID-19 pandemic required contract manufacturers to offer a higher level of flexibility and speed, and this has now become a customer expectation. In the sterile injectable sector, flexibility and the ability to respond quickly to the unexpected have become even more important. The supply of critical drugs to patients on time and without interruption is of the highest priority. CMOs with these attributes built in are most able to rise to this challenge, even during crises, as Avara Liscate continues to do.

Strategic Partnerships Increasingly Important

The supply chain issues highlighted by the pandemic have led many branded biopharmaceutical manufacturers to seek ways to reduce the complexity of their supply chains. They are doing so by reducing the number of suppliers they use and concentrating their attention on building solid, stronger relationships with a limited number of strategic partners.

The sterile injectable CMOs with which Big Pharma companies are forming those strategic partnerships are top-performing, customer-oriented organizations that are focused on manufacturing and share three important attributes: they make the right investments, have the right organizational structure (e.g., flexibility, agility, and personalized customer service), and possess the specialized skills and equipment needed to reliably supply high-quality products with assured sterility.

In addition to branded biopharma companies, many small startups — often spinoffs from universities — are seeking partners that can help them advance their candidates from preclinical development to market. These emerging biotechs are a main driver of growth in the sterile injectables market, so successful CMOs must have the capability to form long-term partnerships with these firms.

Trend Toward More Dedicated Sterile Products

An overarching trend in the pharmaceutical industry today is the shift away from blockbusters and toward more niche, targeted, and personalized or precision medicines. That is certainly true in the sterile injectables sector. Autologous cell therapies, gene therapies, and immuno-oncology treatments are all prime examples of patient-specific medicines. The successful development of mRNA vaccines against COVID-19 has also opened the door for future development of novel therapeutics in this space. Most pharmaceutical companies have programs exploring new mRNA treatments against other infectious diseases, as well as many types of cancer and numerous other disorders. CMOs must develop the capabilities — facilities, equipment, processes, and expertise — to support the manufacture and packaging of small-volume precision medicines, as well as new therapies that require specialized production and fill/finish technologies, such as viral vectors for gene therapies and mRNA treatments prepared using lipid nanoparticles or other novel delivery vehicles.

Making the Right Investments is Essential

That ties into the next important trend, which is a growing emphasis on making the right investments in equipment, infrastructure, and personnel. Sterile injectable manufacturing is complex and challenging because the products are injected or infused into the blood of patients. It therefore requires not only the right type of equipment but also the right-sized equipment to ensure the production of sterile drug products of the highest quality. It is absolutely imperative that capital investments be made appropriately and directed toward the right product areas and the appropriate, state-of-the-art equipment that will ensure sterile injectable manufacturing.


Acceleration of Digitalization

Those companies that were sufficiently flexible and agile to survive the COVID-19 pandemic did so in part because they rapidly adopted new ways of communicating with their stakeholders — employees, suppliers, customers, and regulators, among others. Digital technologies made that possible. While digitalization of the pharmaceutical industry did not start during the pandemic, that unexpected and complicated period certainly accelerated the rate at which digital transformation is occurring — a rate that has not and likely will not decline going forward.

Given that speed is of the essence in drug development, efficiency and productivity are two crucial objectives for pharmaceutical manufacturers. Digitalization is an enabler of both. It facilitates the management and analysis of large quantities of data, contributes to increased quality, and helps to reduce the risk of error.

Digital tools leveraged during the pandemic included software for data sharing to enable remote working, video conferencing, and online meeting software; solutions for the remote monitoring of production operations with real-time data access from mobile phones, laptops, and other devices; and video streaming for remote audits, to name just a few.

Going forward, these technologies, and many more — such as artificial intelligence, robotics and other automation solutions, cloud computing, and so on — will be used to further boost efficiency and productivity and allow for a good balance of on-site and remote work to support the needs of manufacturers and their employees.

De­spite the extraordinary situation that the COVID-19 pandemic present­ed, Avara was able to build on our strong rela­tionships with customers and stay on track with the delivery of needed medicines.

Rapid Pandemic Response at Avara

The COVID-19 pandemic placed everyone in the pharmaceutical industry in a dramatically unfamiliar environment unlike anything previously experienced. Everything was new and in flux, with sudden changes that had to be managed. Contract manufacturers that could adapt to those sudden changes and then continue to meet customer needs not only kept those customers happy but often built stronger relationships with them.

Avara took many measures to ensure the ongoing supply of sterile injectable products for our customers. These products included several drugs used to treat intensive-care patients, such as anesthesia medications. We focused resources on increasing the manufacturing of existing products while also accelerating the transfer of critical new products for the treatment of patients with COVID-19 and other diseases.

New product transfer activities were made possible by implementing the latest communication technologies that enabled close interaction with our customers despite lockdowns and travel bans. For instance, real-time video streaming during audits and during pilot and engineering batch runs ensured business continuity and adherence to very tight timelines.

To overcome equipment shortages, Avara identified opportunities to use — after requalification — existing equipment and components to support product transfers. We were also very open and transparent with our customers about other supply chain issues. In particular, there have been shortages of vials and stoppers, with lead times of 9–12 months. For these materials, we worked closely with our customers to develop specific assessments in support of the use of equivalent commodities.

The preparation of GMP documentation was accelerated by creating parallel work streams and simplifying document storage and access, all while maintaining full compliance with quality and other regulatory requirements. Our project management system was also modified, with the key change being a move to quick, daily meetings with customers to address the various constraints and problems that continually arose and had the potential to impact timelines.


At Avara, we always keep in mind that the final customer is the patient and that our products help alleviate suffering. That was true during the pandemic as well, and, despite the extraordinary situation it presented, we were able to build on our strong relationships with customers and stay on track with the delivery of needed medicines.

A good example of a collaborative effort with a Big Pharma customer involved an Italian hospital. The hospital identified Avara as the manufacturer of an important product used for intensive-care patients for which they were out of stock and needed to receive more immediately. We dedicated a team to this issue, who worked closely with the pharmaceutical company for which the product is made. It was very gratifying to see the aircraft leave our site and head to the hospital with that much-needed medicine. Ultimately, our customer and Avara elected to donate a portion of the volume of this product that we had in stock to the pandemic effort. This was an experience that not only underscored the types of partnerships Avara has with its customers but touched all of us working at the Liscate facility.

As a medium-sized CMO, Avara is appreciated for the focus and dedication that we offer our partners. We are a very customer-centric CMO, with each customer valued highly and appreciated individually. At Avara Liscate, operating in this mode gives confidence to customers with respect to the customer service they receive and the quality of the sterile injectable products we manufacture.

Investing in Stronger Relationships

To meet the increasing needs of customers who require support earlier in their projects — at clinical rather than commercial phase — is a key strategic objective for Avara Liscate. Supporting customers with their clinical trial, product and process development, and dossier creation efforts will allow for the establishment of stronger customer relationships and the building of trust, both of which are crucial as a project advances to the commercial phase. The goal is to help develop the right processes and the right products that will find success in the pharmaceutical market.

To that end, Avara Liscate is investing in the construction of a new department within the facility that will be fully dedicated to product process and development, as well as clinical trial material production.

A Customer-Oriented CMO Partner

As a medium-sized CMO, Avara is appreciated for the focus and dedication that we offer our partners. We are a very customer-centric CMO, with each customer valued highly and appreciated individually. At Avara Liscate, operating in this mode gives confidence to customers with respect to the customer service they receive and the quality of the sterile injectable products we manufacture.

By taking this approach, we continually work to make our company stronger within the CMO world and to ensure the growth of the company. With the right investments, organization, and quality, we can ensure ongoing regulatory compliance, on-time delivery, and excellent customer service.

Creating partnerships with customers involves much more than establishing basic relationships with them. Partners work closely together to resolve any issues that arise and leverage innovative technologies to improve all aspects of performance — flexibility, efficiency, productivity, quality, and pricing.

Ultimately, the most important element that emerges from successful strategic partnerships is trust. Trust is fundamental to the deeper relationships needed for both suppliers and customers today. By engendering trust with our customer partners, Avara Liscate helps them accelerate the commercialization of their sterile injectable products, which translates to greater access to medicines for patients. At the same time, it supports Avara’s goal of becoming a CMO recognized for meeting the current and future expectations of all of our stakeholders.

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