Streamlining OSD Operations from Tableting through Serialization

Streamlining OSD Operations from Tableting through Serialization

Oct 21, 2021PA789

Working with a CMO like Avara‮—‬where oral solid dose‭ (‬OSD‭)‬ drug product manufacturing and packaging are both performed under the management of a single‭, ‬integrated team‮—‬allows clients to benefit from streamlined operations and optimized resources to get their OSD products to patients in need more quickly and cost-effectively‭. ‬

Optimizing Resources

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.‬

Outsourcing for Supply Chain Integration

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. ‬

Integrated Offering at Avara

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.‬

Integration from the Outset

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.‬

Better Change Management

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.‬

Extensive Experience Makes a Difference

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.‬‭  ‬