Evaluating CMO/CDMO End-to-End Expertise: The Importance of Standardizing Cold Chain

Modern medicine is a marvel. New therapies provide promise to slow or cure diseases once considered terminal, technology allows companies to manufacture life-saving drugs en masse, and individualized therapies are more of a reality than ever. The pace of change is rapid and creates an ever-evolving and complex pharmaceutical supply chain that can feel impossible to navigate.

One of the best ways to reduce complexity is to standardize as many processes—or pieces of the supply chain—as possible. A pharmaceutical or biopharmaceutical company’s contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are critical partners in this work. They have an opportunity to offer unique value by standardizing more than just the drug development and manufacturing processes, instead offering end-to-end expertise.

As pharmaceutical and biopharmaceutical companies engage in conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain, they should not forget to include cold chain expertise in the conversation. Cold chain expertise is essential to protect pharmaceutical and biopharmaceutical companies from financial loss and to bring a product to market without delay. It can also be a key differentiator among CMOs/CDMOs.

Here is what pharmaceutical and biopharmaceutical companies should make sure to discuss when talking with CMOs/CDMOs about cold chain expertise.

Cost efficiency

Price is a factor that often drives conversations and weighs heavily against other important considerations in decision-making. Price considerations are important, especially in light of rising cost pressures in the pharma and biopharma industries, but they should extend beyond the price of temperature-controlled packaging to also consider risk mitigation. As many companies have experienced, it is far better to do it right the first time than to pay to do it again.

There are several ways to reduce costs of temperature-controlled packaging. One example could be if a large pharma company was able to reduce bulk shipping thermal packaging costs by a significant amount by switching from single-use thermal boxes and active systems to reusable pallet shippers and reusable parcel boxes. A global network of service centers, network stations, and drop points also minimizes costly delays associated with global shipping logistics and ensures pre-conditioned, ready-to-load units are available on tight timelines.

The costliest delay to consider, however, is temperature excursions. If a thermal packaging container doesn’t adequately protect a drug product, loss of product and significant impact to timelines can cost millions.

Before discussing temperature excursions in greater detail, here are a few specific questions to ask CMOs/CDMOs about cost efficiency of temperature-controlled packaging:

• What product do you use for temperature-controlled packaging? Are the products single-use or reusable?
• Does the vendor you use for temperature-controlled packaging have locations near your facilities? How quickly can they deliver a pre-conditioned, ready-to-load product to your doorstep? How, in turn, has this helped you standardize your cold chain processes?
• Does the vendor you use charge for reverse logistics?
• How does your cold chain vendor help support global shipping requirements?

Temperature excursions

On the surface, temperature control seems easy. But temperature control is complex when one considers the global, and often outsourced, nature of pharmaceutical supply chains. Drug products have unique requirements for temperature control packaging, and newer biologic drug products have different requirements than those in the past. Additionally, an active pharmaceutical ingredient (API) may have a different temperature requirement than the resulting drug product. That means different temperature requirements at different points in the supply chain. Now add keeping a product at the right temperature in transit.

Arguably, the guaranteed ability to keep a product at the right temperature during shipment is the most important cold chain consideration. An excursion during a bulk shipment can have a devastating impact on any drug product delivery. It can push a clinical trial back six or more months, cause significant financial loss, and delay delivery of a critical therapy to a patient in need.

In conversation with a CMO/CDMO, pharmaceutical and biopharmaceutical companies should make sure cold chain offerings meet specific temperature needs—chilled, frozen, or controlled room temperature—and that preferred vendors’ products do not have a history of temperature excursions. Certain technologies provide stronger control than others, including phase change technology and vacuum insulated panels.

Specific questions to ask:

• What cold chain technology do you use or recommend? Why?
• What are the temperature specifications for cold chain products you use or recommend? Does that meet the requirements for your products?
• Does this product have a history of any temperature excursions?
• Are these products regularly used in the pharma and biopharma industries?
• How long have these products been around?

Sustainability

In 2008, Amgen, a global leader in biotechnology, published formal sustainability plans (1). Amgen is not alone in its efforts. Companies like Merck, Eli Lilly, and others also have large-scale sustainability initiatives (2,3). Sustainability is a hot topic of conversation across industries, and consumers are more aware than ever of how brands contribute to sustainability.

It is not enough anymore to practice sustainability solely through business and manufacturing processes a company controls. Consumers expect brands focused on sustainability to ensure sustainability practices throughout their supply chains. This means working with vendors that meet or exceed sustainability standards set within individual pharma and biopharma companies.

One obvious consideration for sustainability within the cold chain industry is whether temperature-controlled packaging is recyclable. However, a move from single-use packaging to reusable packaging helps reduce overall carbon footprint and carbon emissions. A global network of service centers, network stations, and drop points has this same impact—less travel for a product to arrive at a CMO/CDMO doorstep or back to the thermal packaging provider for refurbishment and reconditioning.

Specific questions to ask:

• Does the vendor you use for temperature-controlled packaging have sustainability practices in place? How do they focus on sustainability?
• Does the vendor you work with offer reusable and rental products? If it is necessary to use single-use products, are the components recyclable?
• What happens to waste in the temperature-controlled manufacturing facilities? Is it recycled? How?
• Does the vendor you use have a global network that minimizes travel of temperature-controlled packaging to and from your facilities?

CMOs/CDMOs are invaluable partners. They allow pharma and biopharma companies to focus on drug discovery and marketing and outsource specialized drug development and manufacturing, which reduces overall costs. However, consolidation within the CMO/CDMO industry is common and makes it challenging to understand unique points of differentiation across CMOs/CDMOs.

With more outsourcing to CMOs/CDMOs, creating an even more complex supply chain, it is more important than ever for these partners to offer end-to-end services—including cold chain—and provide greater value. Investing the time to find and work with a partner that offers end-to-end services may take more time up front, but it will save more time and money in the development and manufacturing processes.

References

1. Amgen, “Environment,” amgen.com, July 21, 2020.
2. Merck, “Environmental Sustainability Overview,” msdresponsibility.com, July 21, 2020.
3. Eli Lilly, “Environmental Sustainability,” lilly.com, July 21, 2020.

About the Author

James Klingelhoefer is director of sales, Americas, at Pelican BioThermal.