Supply Chain/Logistics

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

Moderna announces supply agreement with the Argentina government for 20 million doses of Moderna’s COVID-19 vaccine.

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

The availability of materials is a critical factor when it comes to vaccine capacity.

Growth in cell and gene therapies puts pressure on the raw materials supply chain.

Auditing distribution suppliers provides understanding and documentation of the services performed.

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

BioPharm International interviewed Cloudleaf about trends in tracking vaccines through the supply chain.

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.