Pharmaceutical Cold Chain Expertise — The Missing Ingredient In The CMO/CDMO Offering
By James Klingelhoefer
Pharmaceutical supply chains continue to reach new levels of complexity that challenge even the most seasoned logistics and supply chain professionals. These complexities include:
- Innovative, advanced therapies
- Emerging new temperature requirements for products
- Expanding global supply chain to naïve patient populations
- Additional regulatory scrutiny over good distribution practices throughout the supply chain.
Within this evolving world of biopharma, it is estimated that two thirds of biopharmaceutical manufacturing is outsourced.1 Therefore, the supply chain is not only complex, but also largely virtual for pharmaceutical companies bringing their therapies through clinical development and ultimately to market. As a result of the increasing trend of virtual pharma supply chains, pharmaceutical sponsors view relationships with their contract manufacturing partners as not only critical, but vital to the success of their therapies.
Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) offer expertise in manufacturing and development of therapies, allowing their pharmaceutical company customers the opportunity to focus on their core competencies. These pharma partners can provide transformational value, and effectively help pharma companies bring innovative therapies to market. However, the CMO/CDMO landscape has experienced significant consolidation — which can make it difficult for pharma companies to understand the unique, value-creating differences between competing CMOs and CDMOs.
Challenging Forces for Pharma
Although the Biopharma market continues to grow, with a record number of FDA-approved products in 2018, there are several factors that challenge the industry today. For one, drug pricing has become highly visible and scrutinized by the U.S. government and administration. Although it remains unclear on how pharmaceutical sponsors will be impacted by government pricing pressure, it is certain that pharmaceutical companies will seek areas to contain and reduce costs in their supply chains.
In addition to cost pressures, pharmaceutical companies continue to pursue sustainability initiatives. For example, Amgen, a leader in global biotechnology, has published formal sustainability plans since 2008. Amgen is not alone in this effort as many other large pharma companies like Merck, Eli Lilly and others have large-scale sustainability initiatives as well.
In what might be considered a perfect storm, the aforementioned complexity s is also being transformed with innovative therapies (biologics, advanced therapies) requiring strict temperature control even after commercialization. In fact, according to Pharmaceutical Commerce, precisely one half of all FDA-approved drugs in 2018 either require 2-8c refrigeration or cryogenic storage and handling.2
As pharmaceutical companies face these challenges of: supply chain complexity, cost pressure, sustainability and temperature control, how can CMOs and CDMOs provide an innovative offering to solve these challenges?
End-to-End Expertise
Aside from manufacturing and processing high-quality active pharmaceutical ingredients, what if CMOs/CDMOs could offer a true end-to-end solution by ensuring strict temperature control of their products in transit? What impact would these solutions have on their current and potential pharma customers?
By leading and guiding biopharma companies to effective temperature-control strategies, CMOs and CDMOs can create unique value as they act as an extension of the pharma sponsor’s supply chain. After all, even the safest and most effective therapy will have zero impact on patients’ lives if it does not arrive at the destination in viable condition.
Reusable Packaging Systems
Exciting advances in thermal packaging technology have resulted in the emergence of robust and reusable packaging systems. These reusable packaging systems provide temperature assurance for a wide range of temperature ranges, and they accommodate both smaller distribution shipments as well as full pallet shipments (for bulk API/drug product/finished drug product).
With space and capacity constraints at CMO/CDMO facilities, temperature-control solutions also require the same innovation and outside-the-box thinking as today’s therapies. For this reason, it is important for CMOs and CDMOs to partner with thermal packaging companies who can provide pre-conditioned and ready-to-load temperature-control packaging to their doorstep. Additionally, it’s a best practice to seek thermal packaging partners who can support their needs with pre-conditioned, ready to load packaging throughout the CMO/CDMO network wherever they are located in the world — due to the global expansiveness of pharma supply chains.
Reducing Costs by $1 Million
With these new options available to CMOs and CDMOs, companies are now able to address the previously mentioned challenges for their pharma sponsor customers. For example, in working with a large pharma customer on supporting their bulk distribution supply chain, the customer has been able to reduce their thermal packaging costs by over $1 million by switching from active systems, single-use thermal boxes to passive, reusable pallet shippers and reusable parcel boxes. This project has also had a profound impact on the customer’s sustainability goals. It must be noted that both the financial and environmental impact offer net value because the change in packaging systems has also assured avoidance of temperature excursions.
Deepen Partnerships, Provide Value
In a world where biopharma companies exhaust all of their resources with innovative discovery and development of therapies, these companies are greatly impacted by customer-centric CMOs and CDMOs. The ability to not only manufacture high quality product, but also ensure temperature control and viability to the destination, provides value that biopharma companies seek from their partners. CMOs and CDMOs already offer tremendous value to pharma customers, and now they have an opportunity to offer a true end-to-end service.
1 https://isrreports.com/outsourced-pharmaceutical-manufacturing/
