Home > Resources > Whitepapers > Are Nitrosamines aConcern for BiologicManufacturers?

Medical, Industry Outlook

Are Nitrosamines aConcern for BiologicManufacturers?

July 12, 2023

The discovery of nitrosamine genotoxins in several
pharmaceuticals has led to monitoring and re-evaluation of
manufacturing practices for those products considered atrisk. This article provides an assessment of nitrosamine
contamination specifically in biologics and contrasts the
potential risks between these product types.

Spotlight

Nutra Pharma Corporation

Nutra Pharma Corporation operates as a biotechnology company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases.

OTHER WHITEPAPERS

Accurate and reliable cell counting using holographic microscopy and machine learning algorithms

whitePaper | August 11, 2022

Reliable and accurate cell counts are crucial for many different purposes such as the maintenance of cell cultures in biological research or in-process controls in industrial bioprocessing.

Cell and Gene Therapy Hot Buttons Series

whitePaper | September 27, 2022

Cell and Gene Therapy (CAGT) activity has increased dramatically in recent decades, especially in Chimeric Antigen Receptor T-Cell (CAR-T) clinical trials and therapy registrations. The IQVIA CAGT Hot Buttons series covers basic concepts in CAGT for newcomers to this field.

Recruitment, Retention & Diversity: The Evolution of Patient Engagement in Clinical Trials

whitePaper | January 23, 2023

Recruitment, retention, and diversity are critical elements of clinical trials that, if insufficient, can jeopardize successful trial completion.

Cell Lysate Sample Handling with Simoa Bead-Based Assays

whitePaper | November 12, 2019

This document describes a novel Quanterix lysate diluent for running lysate samples with Simoa assays diluent.

Eliminate Noisy Oxygen Measurements in Bioreactors

whitePaper | March 27, 2023

Controlling the dissolved oxygen level in fermentation vessels and bioreactors is vital to maximizing production yield and ensuring high end-product quality.

Understanding Single-Pass Tangential Flow Filtration and the New Era of Bioprocessing

whitePaper | December 22, 2022

Single-pass tangential flow filtration (SPTFF) technology from Pall Corporation is revolutionizing current and future bioprocessing platforms with its implementations in biotech, vaccine and plasma industries. Its features are protected by a portfolio of patents[1-6].