Host Cell Protein Analysis in Biologic Drug Development

January 26, 2019

Host cell proteins (HCPs) are common impurities in biologic drug products and are an obligatory critical quality attribute (CQA). The individual protein contaminants that make up the HCP profile, however, may vary significantly among individual biologic products and expression systems. As such, the HCP profile must be analyzed to identify even low levels of potentially concerning species in a biologic drug to ensure safety and efficacy. This whitepaper reviews fundamental aspects of HCPs pertaining to biologic drug development and current and emerging approaches to HCP analysis.

Spotlight

Envera

Envera is a biotechnology company focused on the use of microbes to treat a variety of issues in a worldwide marketplace. Some applications include; aquaculture, waste water treatment, animal feed supplements, septic system.

OTHER WHITEPAPERS
news image

Transforming cell & gene therapy manufacturing

whitePaper | February 25, 2022

Digitalization and automation promise a better way to streamline the transfer of cell and gene therapies from drug discovery – to commercial production.

Read More
news image

Document quality control emerges as a discipline in its own right

whitePaper | November 19, 2022

Compiling a quality regulatory submission is a basic requirement for biopharmaceutical companies. Poor quality documents could lead to rejection of a regulatory application,

Read More
news image

Early engagement and regulatory considerationsfor biotech

whitePaper | May 10, 2022

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from small molecules, large molecules, and biologics to genomic medicines

Read More
news image

The EU Clinical Trials Regulation − What You Need to Know

whitePaper | March 22, 2022

The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic.

Read More
news image

Impurity profiling and analysis of TheraPure GMP nucleotides

whitePaper | March 22, 2023

Nucleoside triphosphates (NTPs) are key building blocks of many nucleic acid therapeutics and vaccines. These molecules are a vital component of revolutionary new medicines.

Read More
news image

Establishment of the basidiomycete Fomes fomentarius for the production of composite materials

whitePaper | February 24, 2022

Filamentous fungi of the phylum Basidiomycota are considered as an attractive source for the biotech‑ nological production of composite materials. The ability of many basidiomycetes to accept residual lignocellulosic plant biomass from agriculture and forestry.

Read More

Spotlight

Envera

Envera is a biotechnology company focused on the use of microbes to treat a variety of issues in a worldwide marketplace. Some applications include; aquaculture, waste water treatment, animal feed supplements, septic system.

Events