Wednesday, August 17, 2022 Daily Archives

Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

by , , , and

Reduction of Host Cell Proteins (HCPs) to the lowest levels practical requires sensitive and robust analytical methods. In this Special Report, Cygnus Technologies discusses industry best practices for HCP analysis and integration of orthogonal methods for in-depth HCP characterization using Antibody Affinity Extraction (AAE) and Mass Spectrometry (MS). Download the report to learn about: Antibody Affinity Extraction for HCP antibody coverage analysis to ensure HCP ELISA is broadly reactive and fit for purpose of process monitoring and product lot release…

August 17, 2022

Optimizing Bulk Drug Substance Storage and Shipment: Key Considerations for Rigid Container Design

by

When choosing a container for critical drug substances, the material of construction should be your first consideration. It is arguably the most important indicator of container success. Fluoropolymer containers such as Purillex bottles are an excellent choice for BDS storage, freezing, and shipment because of their proven physical and performance advantages. This special report outlines robustness testing of fluoropolymer BDS containers focusing on extractables and leachables, container–closure integrity, durability, gas permeability, and performance during freezing and thawing. Fill out the…

August 17, 2022

What’s new in Baltimore? For Emergent, it’s an FDA warning

by

Aseptic processes and maintenance issues have landed CDMO Emergent BioSolutions a warning letter for its Camden plant – its second Baltimore, Maryland facility to fall foul of regulators in recent months. The 87,000 square-foot Camden facility offers Emergent’s customers clinical and commercial non-viral aseptic fill/finish services across four fill lines. Earlier this year, the plant was visited by the US Food and Drug Administration (FDA) resulting in a Form 483. During Emergent’s results call on August 1, CEO Bob Kramer…

August 17, 2022

Trelleborg to expand silicone tubing MA plant

by

Trelleborg Healthcare & Medical says it will invest several million dollars to expand its manufacturing facility in Northborough, Massachusetts. According to Trelleborg, the expansion project will be conducted in three phases to bring capabilities and capacities online over the next two to three years,, and phase one is anticipated to begin in January 2023. The expansion will increase the company’s manufacturing capacity of class 7 and 8 cleanrooms by 25,000 square feet. And according to Linda Muroski, president of Trelleborg…

August 17, 2022