Kedrion Biopharma

Saleh Yusuf

Supply Chain professionals are constantly improving shipping procedures to transport product in more efficient and cost-effective methods. Whether it is redesigning pallet compositions, scaling up on warehouse rack spaces, upgrading data-loggers, or simply switching the pallet material, improvements are occurring quite frequently. However, if companies do not assess the end-to-end supply chain impact, these innovations may delay and potentially incur significant financial implications to these advances. Angela Symons published in euronews.com that “Spain spent 258 million Euros on 31 commuter trains which was ordered in 2020, set to replace an ageing fleet. However, since the trains are too big to fit in its rail network tunnels, the much-needed update is now delayed until at least 2026”. The biopharma industry is often times found in the forefront of these challenges and Supply Chain professionals are then asked to find swift resolutions while ensuring business continuity.

During the height of the pandemic in 2020, a leading manufacturer and supplier of plasma bottles unveiled a bigger bottle design for collecting plasma. The new design had significant impacts to Supply Chain and left companies searching for resolutions to avoid bottlenecks from shipping plasma upstream and delivering to manufacturers. Changes in pallet compositions are not uncommon in Supply Chain, and professionals in the industry have adapted by developing just-in-time changes. For most instances, a Supply Chain principle is to implement a standard operating practice as it relates to pallet composition. However, one of the changes that the industry implemented and adopted is to have multiple pallet composition designs depending on the warehousing rack limitations at the manufacturer.

More recently, with advancements in cell gene therapy, the biopharma Supply Chain industry has successfully developed and continuing to advance cell gene therapy shipments to ensure that product can be transported in temperatures ranging from -20 to -80, -120 and in some instances below -150 Celsius. 

Once more, the industry implemented new Supply Chain practices that adapted and allowed the flexibility to have

multiple shipping standards in place to meet the evolving business requirements.

What sets the biopharma industry apart from other industries relating to Supply Chain innovations and advancements is that the margin of error is considerably smaller in scale and on occasion non-existent.

Furthermore, changes are administered by change control requests which is reviewed by Compliance and various stakeholders internally and externally-if warranted. This is necessary to ensure that all stakeholders are first made aware of the implementations and to verify that all implementations are in accordance with governing agency guidelines and rules by which it must comply with. In addition, this shift impacted the way Quality and Supply agreements are established to accept, acknowledge, and adapt for multiple scenarios and anticipating frequent changes which may occur.

One setback to the change and acceptance of variability in Supply Chain practices exposes the department to more errors if not monitored with scrutiny. To limit these errors, companies have implemented heightened and additional checkpoints and approvals to mitigate and limit these errors.

Change and innovation is inevitable, and the biopharma industry is frequently the pioneers. Supply Chain professionals in the industry have pivoted by being receptive to flexible shipping methods depending on multiple factors and criteria. These constant advancements and evolutions in the biopharma industry has caused a shift in Supply Chain practices and additional accountabilities in an organization.