Biopharmaceutical cold chain best practices
Small molecule drugs have ruled the pharmaceutical market for many decades. More recently, however, biological medical products – or biopharmaceuticals (e.g. proteins) – are gaining more attention and represent a significant share of drug research and development nowadays.
Important benefits of biopharmaceuticals are:
- the higher selectivity towards their target compared to small molecules,
- leading to higher efficacy and less side effects,
- which in turn increases patient comfort and adherence.
Although biopharmaceuticals have many advantages, the production process of these compounds is more challenging and the production cost is usually higher when compared to small molecule drugs.
Also, as biopharmaceuticals are fragile and very temperature-sensitive, these compounds must be handled within strict condition tolerances to ensure product integrity. This is why investing in an efficient cold chain – the management of temperature-sensitive products as they move through the supply chain – is of utmost importance when producing high-value biological drugs.
There will be a need to invest in physical infrastructure especially designed to operate biopharmaceuticals.
Handling high-value compounds will need an in-depth understanding of risk-cost balance as both cost and risk are high for biopharmaceuticals. Well-defined standard operating procedures will be more important than ever, as well as technology and big data analytics to make better decisions and reduce risk. And last but not least: guaranteeing product integrity in a temperature-controlled supply chain will require a collaborative effort between the manufacturer and its logistics service providers.
READ FULL ARTICLE (Source: JOC - Journal of Commerce)
How can we at CMAST help?
CMAST's Supply Chain Project Managers and Business Consultants can support you in setting up your cold chain, or can assist in improving its efficiency.
Edith Oyen, Project Manager
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