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Isolere Bio is on a mission to transform biomanufacturing and tackle the traditional limitations in downstream processing with its novel IsoTag reagents. This first-of-its-kind technology is based on ...

As of its 2023 guidance on combination and boundary products, the Australian Therapeutic Goods Administration (TGA) has provided context around key regulated product categories: Combination products ...

Biologics have revolutionized the medical landscape with their targeted mechanisms of action and potential for treating a wide array of indications. As the global population grapples with an ...

Ensuring regulatory compliance and maintaining high-quality standards is fundamental in the pharmaceutical industry. However, the conventional approach of computer system validation (CSV) is proving ...

In this informative white paper, WuXi Biologics delves into how WuXi Biologics addressed the critical need for speed in moving biologics from DNA to Investigational New Drug (IND) application ...

This webcast features: Artur Stanczak, Field Application Specialist, Process Chromatography, Bio-Rad Laboratories. Large molecule purification presents significant challenges due to their considerable ...

Founded in the middle of 2002, BPI published its first issue in January of 2003. Our 20th-anniversary issue thus takes the form of a state-of-the-early-21st-century industry report. Assembling this ...

With Anne Montgomery’s retirement this past November, I am now the last founder standing on the BPI staff. It began in 2002 as an idea from Brian Caine and Stephanie Schaffer on the business side with ...

As I look forward to retirement and revisit 35 years in publishing, I marvel at all the adventures that a graduate degree in comparative literature can lead to. I’d always dabbled in biology, but for ...

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. When ...