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

Medical, Industry Outlook

Are Nitrosamines aConcern for BiologicManufacturers?

July 12, 2023

Are Nitrosamines a Concern

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

PTC Therapeutics, Inc.

PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders.

OTHER WHITEPAPERS

BIOTECHNOLOGY UPDATE

whitePaper | April 24, 2022

The Global Forum on Biotechnology, established in 2010, is one of 15 Global Fora created by OECD Committees. Global Fora are not official OECD bodiesbut are best described as broad.

Read More

A Playbook for Emerging Biotechs

whitePaper | March 24, 2023

The global biotech industry continues to witness growth with an estimated market size of nearly $300B, despite the current state of the funding environment

Read More

Accelerating the Biomanufacturing Revolution

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.

Read More

Use of PS-DVB Columns and Matched Buffers in the Purification and Scale-Up of mRNA Drug Candidates

whitePaper | August 24, 2022

The validity of mRNA as an approved pharmaceutical is now largely accepted, with the historic launch and administration of billions of doses of mRNA Covid vaccines (1).

Read More

Application of Single-Use Technologies(SUT) in Biosimilar Development

whitePaper | December 20, 2022

The current processing paradigm of large manufacturing facilities dedicated to singleproduct production is no longer an effective approach for best manufacturing practices.

Read More

Gene, Cell, & RNA Therapy Landscape

whitePaper | January 24, 2022

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization.

Read More

BIOTECHNOLOGY UPDATE

whitePaper | April 24, 2022

The Global Forum on Biotechnology, established in 2010, is one of 15 Global Fora created by OECD Committees. Global Fora are not official OECD bodiesbut are best described as broad.

Read More

A Playbook for Emerging Biotechs

whitePaper | March 24, 2023

The global biotech industry continues to witness growth with an estimated market size of nearly $300B, despite the current state of the funding environment

Read More

Accelerating the Biomanufacturing Revolution

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.

Read More

Use of PS-DVB Columns and Matched Buffers in the Purification and Scale-Up of mRNA Drug Candidates

whitePaper | August 24, 2022

The validity of mRNA as an approved pharmaceutical is now largely accepted, with the historic launch and administration of billions of doses of mRNA Covid vaccines (1).

Read More

Application of Single-Use Technologies(SUT) in Biosimilar Development

whitePaper | December 20, 2022

The current processing paradigm of large manufacturing facilities dedicated to singleproduct production is no longer an effective approach for best manufacturing practices.

Read More

Gene, Cell, & RNA Therapy Landscape

whitePaper | January 24, 2022

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization.

Read More

More Whitepapers

Spotlight

PTC Therapeutics, Inc.

PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders.

Events