Home > Resources > Whitepapers > Document quality control emerges as a discipline in its own right

Cell and Gene Therapy, Industrial Impact

Document quality control emerges as a discipline in its own right

November 19, 2022

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

I'm For Real

Enter your details once to access all our information and resources

Spotlight

Biothera Pharmaceuticals, Inc

Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that enhances the efficacy of tumor-targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. The Company has clinical research agreements with Merck to evaluate Imprime PGG and Merck’s KEYTRUDA (pembrolizumab) in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer.

OTHER WHITEPAPERS
news image

Challenges and Solutions for Gene Therapy manufacturing

whitePaper | November 17, 2022

Gene therapy is the modification of specific genes in targeted cells in order to address genetic mutations that cause some of the most debilitating human conditions.

Read More
news image

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
news image

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].

Read More
news image

Synthetic Biology Biotechnology and AgTech

whitePaper | March 12, 2022

CRISPR, gene editing, biotech, precision agriculture and automation influencing the future of business, government, food, medicine, geopolitics and society

Read More
news image

A Cornerstone in the Supply Chain of Cell-based Therapies

whitePaper | February 15, 2023

The diverse therapeutic attributes of mesenchymal stromal cells (MSCs) lend to their rapid development as cellular therapeutics. These unique attributes include potent immu nomodulatory properties [1,2], the potential to differentiate into multiple cell lineages.

Read More
news image

Bold Goals for U.S. Biotechnology and Biomanufacturing

whitePaper | March 22, 2023

The world is on the cusp of an industrial revolution fueled by biotechnology and biomanufacturing. Emerging biological technologies are and will continue to transform the foundation of our physical world – everything from clothing, to plastics, to fuels, to concrete.

Read More

Challenges and Solutions for Gene Therapy manufacturing

whitePaper | November 17, 2022

Gene therapy is the modification of specific genes in targeted cells in order to address genetic mutations that cause some of the most debilitating human conditions.

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

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].

Read More

Synthetic Biology Biotechnology and AgTech

whitePaper | March 12, 2022

CRISPR, gene editing, biotech, precision agriculture and automation influencing the future of business, government, food, medicine, geopolitics and society

Read More

A Cornerstone in the Supply Chain of Cell-based Therapies

whitePaper | February 15, 2023

The diverse therapeutic attributes of mesenchymal stromal cells (MSCs) lend to their rapid development as cellular therapeutics. These unique attributes include potent immu
nomodulatory properties [1,2], the potential to differentiate into multiple cell lineages.

Read More

Bold Goals for U.S. Biotechnology and Biomanufacturing

whitePaper | March 22, 2023

The world is on the cusp of an industrial revolution fueled by biotechnology and biomanufacturing. Emerging biological technologies are and will continue to transform the foundation of our physical world – everything from clothing, to plastics, to fuels, to concrete.

Read More
More Whitepapers

Spotlight

Biothera Pharmaceuticals, Inc

Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that enhances the efficacy of tumor-targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. The Company has clinical research agreements with Merck to evaluate Imprime PGG and Merck’s KEYTRUDA (pembrolizumab) in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer.

Events