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 ...

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 ...

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 ...

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 ...

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 ...

This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover ...

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need ...

This website (the “Site”) is operated by Informa Connect, a trading division of the Informa Group. The parent company of the Informa Group is Informa PLC. Informa Connect (“Informa Connect”, “we” or ...

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 ...

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 ...

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 ...