Supply Chain Featured Articles

1. Clinical Supply Packaging For Biological Products 5/25/2018

   The advantages of biologics over their small molecule predecessors are not without their costs. This e-book addresses the challenges in managing the biologic supply chain.

2. Understanding And Delivering Your EU Orphan Drug Launch 8/25/2017

   Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.

3. Advancing Clinical Study Execution And Expediting Clinical Supplies 3/13/2017

   The shift toward biologics, globalization of clinical trials, and regulatory and commercial pressures has placed new stresses on clinical supply chains.

4. Choosing A Vaccine Storage Temperature Logger: 5 Things To Look For 10/18/2016

   In the life science and healthcare industries the proper storage of temperature-sensitive products – specifically vaccines – is a fundamental and growing concern with respect to public health.

5. Using Temperature-Sensitive Monitoring With 21 CFR Part 11 Systems 10/18/2016

   This app note is intended to clarify how Onset’s InTemp monitoring solutions and technology are compatible within an environment where 21 CFR Part 11 is being employed.

6. Data Beyond Temperature: Digital Integration Of The Supply Chain Boosts Support Of Advanced Therapy Products 2/18/2016

   The White House 2012 National Bioeconomy Blueprint forecasts that increased cell manufacturing research activities would lead not only to significant improvements in public health, but also provide tremendous economic benefits to the next generation of biotechnologies. Predictably, groundbreaking techniques to elevate quality assurance, increase efficacy, enable production scale-up, and reduce manufacturing and product cost of requisite bioprocesses are needed to support the long-term growth of the regenerative medicine industry.

7. Drug Serialization: Key To Protecting Patients In U.S. And International Markets 2/12/2016

   Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise.

8. Biopharma Climbs The Serialization Mountain 2/11/2016

   The data associated with drug-product serialization will be Everest-like; accessing it may pose every bit the security risk. The difference is millions of people may be trying to access the summit … every day. What’s clear today is that a national program for drug serialization looms large on the horizon, and rises, if you will, high into the data clouds.

9. The Solution to Temperature-Sensitive Pharmaceutical Sampling 10/26/2015

   Despite advances across the supply chain, biological pharmaceutical drugs vulnerable throughout the last mile – the final supply chain leg of pharmaceutical products to healthcare providers and patients – due to their temperature-sensitive nature.

10. How To Strengthen Risk Management Practices In The Pharmaceuticals Supply Chain 6/25/2015

    The end customers — i.e. the patients — are largely uninterested in the complexities of the pharmaceutical supply chain, and if something goes wrong in the supply chain the responsibility and consequences are inevitably borne by the pharmaceutical manufacturer listed on the product pack. Management of these risks in order to ensure supply continuity is a significant challenge. Here are a few key best practices: