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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 ...

Filter integrity is a fundamental element of sterility assurance during production of biopharmaceutical and vaccine products. Integrity test results are a key foundation for drug lot release, so any ...

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 ...

From 30 March to 2 April 2015, more than 750 professionals gathered at the Hyatt Regency Resort in Huntington Beach, CA, to attend the annual Biopharmaceutical Development and Production meeting.

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 ...

Market experts recommend automated filling systems for drug developers seeking to reach the next level in drug-substance management. Many companies are starting automation initiatives, which suggests ...

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 ...