Supply Chain

Biopharmaceutical Industry Calls on Vendors To Commit to a Greener Supply Chain

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Chief executive officers (CEOs) and board chairs from Roche, GSK, and AstraZeneca are among seven signatories on an open letter calling for bioprocess suppliers to commit to specified climate and sustainability targets. Stating that the healthcare sector contributes about 5% of global greenhouse gas emissions, half of which comes from its supply chain, the authors call on their biopharmaceutical-ecosystem partners to move rapidly together toward a “greener, more efficient, and circular” process. The letter is signed by representatives of big…

September 19, 2023

Post-COVID Supply-Chain Challenges Are Easing, Part 2: Impact of Increased Vendor Competition on Pricing

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New competitors entering the bioprocessing industry during the COVID-19 pandemic gained access partly because of unprecedented demand and constrained supply of bioprocess materials, equipment, and consumables. During the pandemic, growth in supplier revenue increased dramatically, averaging >24% growth in 2022, with some segments of the industry showing even higher growth (1). The 20th annual report of biopharmaceutical production from BioPlan Associates also assessed price changes and competitive pressures resulting from the demand swings over the past few years. The bioprocess…

August 17, 2023

The Role of Artificial Intelligence in Managing Postpandemic Supply-Chain Risks

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In May 2023, the World Health Organization (WHO) declared an end to the COVID-19 pandemic (1). Despite that announcement, fallout from the pandemic continues to reverberate through global supply chains, exposing their opacity and fragility and catalyzing their transformation. Geopolitical issues, such as Russia’s invasion of Ukraine and rising tensions between the United States and China, have shaped supply-chain transformation, resulting in what I call a “supply-chain iron curtain” that is poised to complicate international trade (2). But that does…

August 17, 2023

Post-COVID Supply-Chain Challenges Are Easing, Part 1: New Competition Is Changing Industry’s Buying Behavior

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The SARS-CoV-2 pandemic created unprecedented stresses on bioprocessing and healthcare supply chains as suppliers struggled to find materials to meet demand for COVID-19 vaccines and therapeutics. BioPlan Associates, with BioPhorum and its members, recently researched the biomanufacturing industry’s response to the pandemic and prepared a white paper, Impact of COVID-19 on the Bioprocessing Supply Chain (1). Before COVID-19, the bioprocess supply industry had been growing consistently at 12–14% (nearly doubling revenue every five years) since 1990. During COVID, growth in…

June 26, 2023

eBook: Working Together Is Key to Bioprocess Sustainability

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Sustainability initiatives are launching across the biopharmaceutical industry as companies begin to scrutinize their environmental impacts as part of the growing environmental, social, and governance (ESG) movement in business. Achieving ambitious sustainability goals will require organizations to evaluate their raw materials, production processes, product packaging, operations, and supply and distribution chains — and such work will entail monumental effort. Herein, BPI managing editor Brian Gazaille speaks with Brian Fahie, head of analytical development at Biogen, about that company’s efforts to…

May 30, 2023

Addressing Gaps in US Biomanufacturing Capacity

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In December 2022, the President’s Council of Advisors on Science and Technology (PCAST) submitted a report to Joe Biden about biomanufacturing in the United States. In a letter prefacing the report, the council cochairs noted that the bioeconomy is “poised for enormous growth over the coming decades” (1). On 22 March 2023, the White House Office of Science and Technology Policy responded with a set of five initiatives to help realize the potential of the nation’s bioeconomy. The broad goal…

May 23, 2023

eBook: The Post-Pandemic Supply Chain

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Supply chains felt the full force of the COVID-19 pandemic, leading the industry to rapidly adopt new protocols. Additional forces have also exposed the supply chain to even more complex issues such as increased lead times and sustainability. This eBook examines the lessons learned from the pandemic that have become standard among biomanufacturers and how rising macroeconomic threats such as inflation and climate change continue to force supply chains to evolve. Jim Marshall, associate director of materials management at Alnylam,…

March 27, 2023

How To Achieve DSCSA Compliance by November 2023

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As the world surges into the new year, pharmaceutical companies that manufacture pharmaceuticals in and/or for the United States seeking to comply with the Drug Supply Chain Security Act (DSCSA) may find themselves scrambling to meet the 27 November 2023 deadline requiring them to track and trace prescription drug products within the supply chain. Congress enacted the 60-page DSCSA in November 2013 as Title II of the Drug Quality Security Act (DQSA) to protect patient safety. That provided the pharmaceutical…

February 9, 2023

Cell Therapy — Supply Chain Discussions

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The 2017 approval of Kymriah (tisagenlecleucel) has paved the way for other cell therapy products to reach the patients who need them. Each passing year promises to open the regulatory floodgates to more product approvals, but technical and manufacturing issues continue to keep initially high expectations from being realized. One barrier is supply chain complexity, especially for the subset of autologous cell therapies. This eBook features expert commentary from Be The Match BioTherapies, a company providing more than 50 product…

December 15, 2022

Managing Patient Data in the Supply Chain

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The personalization of autologous advanced therapy medicinal products (ATMPs) makes patients an intrinsic part of the supply chain. It begins with collection and registration of starting materials, which necessitates tracking and recording chain-of-identity (CoI) and chain-of-custody (CoC) information for every dose. This situation could expand the challenges of patient data management throughout the whole supply chain, increasing data privacy risks to both patients and suppliers. ATMP manufacturers must therefore protect data privacy not only as clinical trials start, but also…

December 6, 2022