Supply Chain/Logistics

Taking a brief status check on the biologics supply chain and any impact on scale up operations.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

A proposed database includes key information about critical drugs, such as the country of origin and quantity, so supply chain weaknesses can be identified.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

Problems continue despite actions by regulators to better prevent and address drug shortages.

Vaccine nationalism strengthens viruses and poses deadly risks for all involved.

Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

There is an evolution in the way technology and best practices are blended to meet cold-chain supply requirements for temperature-sensitive biotherapeutics.

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

mRNA may not be a train we necessarily all need to get onboard immediately, but we should know where the central train station is located, and what it connects us to.

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.

High-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

Technological developments in real-time supply chain operations provide biologics manufacturers with capabilities that go beyond supply chain visibility to tangibly address security and quality challenges.

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.