Author Archives: Alpana Naresh

eBook: Speed to IND — Practical Wisdom for Uncertain Times

Even in “normal” times, companies need to balance time to filing an investigational new drug (IND) application against careful consideration of processes that can have far-reaching consequences on the quality of biologic products. But supply-chain interruptions still feature prominently in the news during the ongoing COVID-19 pandemic. From equipment to chemicals to plastic components, end users, their suppliers, and (critically) their suppliers’ suppliers all are feeling growing uncertainty about production timelines and availability of materials. In this eBook, BPI’s editor…

A Novel Chromatographic Technology: Enhancing Performance Utilizing a Modular, Lattice Supported Resin Bed

This poster highlights the Chromacassette® Technology: First practical modular chromatography platform. Supported-bed enables packing of any resin bead. Constant bed permeability, independent of resin compressibility even at V > 1000 cm/hr. Truly linear scalable. Eliminates packing methods and equipment. New operating domains and resin design are now possible for both bind and elute and flow-through. Hyper-Productive™ process enabling for single-use chromatography. PD devices will be available early 2018.

Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab)

Four Protein A resins from leading industry vendors, including Amsphere™ A3, were screened for use in a capture step for a Herceptin biosimilar. Multiple parameters were assessed for their performance against the platform resin. Initially, a dynamic binding capacity (DBC) determination was made using a standard 4-minute residence time (RT) using purified protein. Performance of the resins were then screened for recovery and purity using harvested cell culture fluid (HCCF) where the MAb load was 80% of DBC at 10%…