Featured Editorial
-
Key Considerations For Early-Stage CGT Companies When Selecting A CDMO
12/16/2024
For preclinical or early-stage cell or gene therapy companies, proper evaluation of each CDMO candidate should include the raw materials program, QC testing, and more.
-
Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
-
AstraZeneca's Digitally Connected Strategy For API Manufacturing
12/3/2024
The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.
-
The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
12/2/2024
These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.
-
Solving The Leukopak Supply Chain Issue With Cryopreservation
11/25/2024
Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.
-
Is The BIOSECURE Act The First Real Step Toward Reshoring?
11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
-
Defining When To Implement Technologies To Support Commercial Growth
11/20/2024
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
-
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
11/19/2024
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
-
Considerations For Potency Assurance Of CGT Products
11/12/2024
Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.
-
3 Focus Areas To Transition From Clinical To Commercial Readiness
11/12/2024
Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.