Pharmaceutical Cold Chain Expertise — the Missing Ingredient in the CMO/CDMO Offering

Pharmaceutical Cold Chain Expertise — the Missing Ingredient in the CMO/CDMO Offering

By James Klingelhoefer, Pelican BioThermal
 
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.

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1  https://isrreports.com/outsourced-pharmaceutical-manufacturing/
2 https://pharmaceuticalcommerce.com/brand-marketing-communications/fda-set-an-all-time-record-of-new-drug-approvals-in-2018/