The supply chain has been the subject of increased worldwide attention amid disruptions caused by the COVID-19 pandemic. But for contract development and manufacturing organizations (CDMOs), mitigating supply chain risk is always a top priority. CDMOs are responsible for navigating complex global supply chains that involve everything from receiving raw materials for drug development to shipping commercial drugs. While COVID-19 placed unique stressors on the biopharmaceuticals industry, Samsung Biologics, a leading CDMO, was able to mitigate supply chain risk with an innovative approach.
Samsung Biologics developed several risk management strategies, including multivendor sourcing, alternative single-use materials, stainless steel systems, and innovative platform processes. These strategies were particularly helpful during the pandemic, but they also stand to provide long-term supply chain benefits for Samsung Biologics’ clients.
COVID-19 and CDMO Supply Chains
Following the onset of the pandemic, biopharma companies manufacturing COVID-19 vaccines and therapies had limited in-house capacity to keep up with demand, leading them to rely on CDMOs for manufacturing. But with several COVID-related issues causing a ripple effect of disruptions across the supply chain, CDMOs faced significant raw materials shortages and delays.
The shortage of raw materials didn’t just impact the rate at which COVID-19 vaccines and therapies were manufactured. Importantly, the priority for raw material usage placed on COVID-19 vaccines and medicines meant the manufacture of other therapeutics requiring those materials could be stalled.
To continue to provide its clients with the manufacturing speeds they count on, Samsung Biologics executed a variety of supply chain strategies based on assessments and specific client requirements.
Working closely with clients, Samsung implemented the following strategies to mitigate supply chain risk.
1.) Multivendor Sourcing
Custom assembly raw materials require longer lead times, which means they present a higher risk for supply chain disruptions. Relying on a single vendor to supply these materials can leave a CDMO vulnerable to delays if that vendor encounters an unexpected supply chain issue.
During the pandemic, if a primary vendor was unable to supply these materials in time to meet client needs, Samsung Biologics turned to secondary and tertiary vendors to source the needed raw material components. This process involved qualifying the new vendors and working closely with clients to implement alternate assemblies.
While multivendor sourcing proved to be particularly helpful during the pandemic, the strategy also has long-term viability. Samsung Biologics continues to employ multivendor strategies in new product projects, sourcing and qualifying as many as three different vendors during the project’s initial phase. This proactive approach means any of the different assemblies can be used from the beginning of the project if needed.
Proactive multivendor sourcing allows Samsung Biologics to access the materials it needs to meet the specific time frame requirements clients expect when they rely on a CDMO, even if the primary raw materials vendor is facing unexpected supply chain disruptions.
2.) Alternative Single-Use Materials
In addition to multivendor sourcing of raw materials, Samsung Biologics introduced its own alternative single-use materials. These include secondary containers such as plastic bottles and bags that are ready to use if an issue affects the primary containers involved in a project.
If an issue arises with containers during the development of a clinical product with a strict timeline, the extensive testing required to introduce new containers would stall the project significantly. Samsung Biologics avoids this issue by having the appropriate secondary containers available and ready to use.
3.) Stainless Steel Systems
Another strategy for avoiding problems caused by shortages of single-use raw materials is implementing systems with much less consumable materials. Samsung Biologics’ stainless steel capabilities provide it with a viable alternative to single-use raw materials, mitigating risks caused by materials shortages.
Samsung Biologics’ stainless steel systems include tanks of various sizes, portable vessels, and filling lines. While these systems require additional preparation and cleaning time, their reliability is invaluable during single-use raw materials shortages such as those experienced following the onset of COVID-19.
4.) Innovative Platform Processes
Faced with supply chain disruptions that can potentially delay a project, a CDMO that can expedite tech transfer and production will set itself apart. Samsung Biologics continues to innovate in the development of platforms that enable projects to be completed quickly and efficiently.
In 2021, Samsung Biologics introduced its proprietary S-CellerateTM platform, which is designed to accelerate cell line development to Investigational New Drug Application (IND) and Biologics License Approval (BLA) timelines by offering clients a quality-driven, seamless drug development approach.
To ensure a seamless transition from clinical to commercial without disruptions, the operations are performed at a fully integrated, single site with a risk-free accelerated supply using single-use or stainless-steel technologies for clinical batches, ultimately allowing Samsung Biologics’ clients to avoid supply chain impacts.
Proactively Mitigating CDMO Supply Chain Risk
The COVID-19 pandemic sent shock waves through the global supply chain and was a clear reminder of its vulnerability to unexpected risks. While it can be difficult to predict how the supply chain will be disrupted, CDMOs can still take steps to develop more agile supply chain strategies.
Samsung Biologics’ innovative strategies for adapting to raw materials shortages are a prime example of how a CDMO can proactively mitigate supply chain risk. These strategies helped Samsung Biologics navigate the supply chain disruptions caused by COVID-19, and they will continue to help avoid supply chain issues in the future.
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