Author Archives: Alpana Naresh

eBook: Speed to IND — Practical Wisdom for Uncertain Times

Even in ā€œnormalā€ 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 suppliersā€™ suppliers all are feeling growing uncertainty about production timelines and availability of materials. In this eBook, BPIā€™s editor…

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

This poster highlights the ChromacassetteĀ® 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-Productiveā„¢ process enabling for single-use chromatography. PD devices will be available early 2018.

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

Four Protein A resins from leading industry vendors, including Amsphereā„¢ 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%…