October 21, 2021
Before the COVID-19 pandemic, the pharmaceutical industry was already under tremendous pressure to reduce costs and meet expectations for value-based pricing. Pharmaceutical companies continue to be challenged to more rapidly develop and commercialize novel therapies that address unmet medical needs and offer them at reasonable prices.
Indeed, the complexity of the supply chain and the issues that this complexity creates have been brought into greater focus by the pandemic. The pharma companies best able to weather this crisis have been those that have already integrated their supply chains to at least some degree.
For OSD drug products, manufacturers often partner with two different CMOs—one that manufacturers the drug product and one that packages that drug product into its final form. This approach requires the management of two different CMOs, each with a different supply chain. In addition, the drug manufacturer must mediate product transfer from one CMO to the other.
Working with a single CMO that has demonstrated capability to meet GMP requirements for both OSD drug product manufacturing and packaging, ideally at one site, helps drug companies streamline these activities and optimize resources for each project. Working with a single CMO across drug product manufacturing and packaging eliminates not only the need to manage two partners and their supply chains, but also the time and cost of transferring the product from one CMO to another.
Ultimately, using an integrated CMO helps drug makers—regardless of whether they are smaller companies with limited resources or larger companies looking to simplify their outsourcing activities—to get their OSD products to patients in need more quickly and cost-effectively. It really is an advantageous model for everyone.
Additionally, partnering with the right CMO can help pharmaceutical companies to integrate their supply chains and uncover new efficiencies. A strategic relationship with a CMO can allow companies to avoid both overhead costs and prohibitive startup costs. Time to market, often critical for a successful product launch, can also be significantly decreased through partnering with a CMO. Outsourcing can provide a company with access to specialized equipment and manufacturing expertise that may not be a core competency internally. Since lead times for specialty equipment manufacturers are continually increasing due to component availability, partnering with a CMO with the needed specialty equipment in place can avoid delays a time to market caused by sourcing challenges. Finally, during times when labor shortages are relatively widespread, rather than building up a new labor force internally, it can be far quicker and more efficient to engage with an outsourced manufacturer that already has teams trained, in place, and ready to begin a program rapidly.
Avara Pharmaceutical Services offers a solution for the strong market need for a CMO that can enable supply chain integration. All activities are performed by people with extensive experience in the pharmaceutical industry on both the CMO and sponsor sides who recognize that everything they do impacts the health and well-being of patients.
In addition, Avara’s employees are supported by a strong safety, health, and environmental system and an Operational Excellence and Compliance–oriented program developed using Lean Six Sigma methodologies. As a result, Avara brings a wealth of process and industry knowledge and expertise in supply chain management, commercialization, and technical transfer to bear on customer projects, facilitating the rapid, cost-effective production of advanced medicines.
At our Norman, Oklahoma, site, OSD manufacturing and packaging have always been core capabilities. And the existing manufacturing and packaging capabilities were expanded with serialization and aggregation solutions in recent years.
An integrated supply chain, manufacturing, and packaging engineering team provides combined support from the outset of each project. This approach consolidates efforts and ensures that all factors that might impact the final packaged product are taken into consideration up front, reducing risk. At the Norman site, we have the small-scale equipment to produce bottles and blisters to accelerate the registration of packaged drug products. Additionally, we have the ability to conduct packaging trials on early tech-transfer material and perform stability testing on those packaged samples to accelerate development of the packaging process.
Working with a single CMO across drug product manufacturing and packaging eliminates not only the need to manage two partners and their supply chains, but also the time and cost of transferring the product from one CMO to another.
Another important advantage associated with using a single CMO for OSD drug product manufacturing and packaging is the mitigation of the impact of change. For instance, if a schedule change or something similar occurs during manufacturing to cause a shift in the overall production plan, a single team can quickly adapt. This is because, with Avara’s integrated approach and use of a cross-functional team, everyone receives the information at the same time, significantly limiting the likelihood of surprises. Also, because a single group controls both the manufacturing and packaging schedules, there is much greater agility and flexibility, and adjustments are made immediately. The greater understanding of the way material will be coming out of manufacturing line and moving into packaging limits the impact of any changes to timelines or validation plans and drives the overall success of the project.
Streamlining is not something that was considered important in the past, and, while many companies recognize the value now, some hesitancy remains to transition to this model due to fear of switching from existing groups with known attributes and capabilities to a new CMO. However, at Avara, we have offered integrated drug product manufacturing and packaging at the Norman site for many years and have worked through most typical issues. As a result, Avara is able to help our customers achieve optimum resource utilization and leaner project execution.
The foundation and vision of Avara is to accelerate the delivery of drugs to the marketplace while navigating through industry changes. Integrating OSD drug product manufacturing and packaging is one key example of how we are achieving this goal.
We are committed to developing new ways to drive efficiencies while also providing security of supply, enhancing regulatory compliance, and building long-term confidence. At Avara, we have a desire to help drive changes for the good of the industry that will ultimately deliver long-term benefits to patients.
Richard Walkup has 18 years of experience in manufacturing, the last 13 of which have been spent in the pharmaceutical industry, with a special focus on process engineering. At Avara Norman, Richard leads the technical services group in all manufacturing and packaging processes, including technical transfer and process validation. By supervising products throughout their lifecycle, Richard helps ensure we deliver on our pledge to manufacture quality products for our global clients and patients.