Supply-Chain Transformation: Strategic Necessity for the Life Sciences - New supply-chain challenges are forcing companies to act in different ways to secure product safety. - BioPharm International

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Supply-Chain Transformation: Strategic Necessity for the Life Sciences
New supply-chain challenges are forcing companies to act in different ways to secure product safety.


BioPharm International Supplements
Volume 24, Issue 3, pp. s19-s22

The fine balance between supply and demand

In common with big pharmaceutical companies, biopharmaceutial companies are reevaluating their supply chains and looking at outsourcing and contract manufacturing as a growth strategy. However, unlike traditional pharmaceutical companies, who are currently focusing on reducing costs, biopharmaceutical companies are more concerned about managing the risk factors that have been introduced throughout their extended supply chains. This difference was evident during presentations and panel discussions at the Biotech Supply Chain Academy event held in San Francisco, in October 2010. Concerns related to supply disruptions, particularly for single- or sole-source suppliers, were common. The impact of a shortage, or worse, contamination, of a key ingredient that could prevent manufacture of crucial compounds was a major concern. Whether considered from the viewpoint of financial loss, reputational risk, or patient safety, supply disruptions are a major challenge for biopharmaceutical companies. As products move from discovery to commercialization, stabilizing supplier relationships is crucial, but complicated. Projecting demand for new compounds requires close communication between manufacturers and healthcare professionals.

An additional factor for consideration is an increasing focus on the patient, in many cases requiring specialized supply-chain management and oversight from manufacturing location to the end user. Because some biotechnology products are designed and developed to address issues for small patient communities, the sector has facilitated an environment of patient intimacy, with close cooperation between companies, caregivers, and beneficiaries. This advantage should be incorporated into supply-chain strategies.

Additional risk factors for biotech companies

In the case of biotechnology products, the stability of the ingredients and components is a crucial element and one that needs to be managed across the product life cycle, from acquisition and transformation to distribution and consumption.


Figure 1. Respondents indicate the phase of process development during which they first consider cold-chain management (Data reprinted with permission from the Sixth Annual Report and Survey of Biopharmaceutical Manufacturing, BioPlan Associates, 2009).
Cold-chain management is a key factor for nearly all biotechnology products. However, this challenge is not always taken into account during the transition from discovery and product approval to the commercial-manufacturing stage. Figure 1 reflects responses on this topic from the Sixth Annual Report and Survey of Biopharmaceutical Manufacturing, conducted by BioPlan Associates in 2009.

According to Eric Langer, president of BioPlan Associates, "Cold chain management of biologics is becoming an increasingly important function in the overall marketing, manufacturing, and production of these products. If the infrastructure for delivering these products to end-users is not available, or is inadequately controlled, product quality and drug efficacy may be compromised. As global markets for biologicals expand, this has become an increasingly important issue."


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