Medical White Papers

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Medical White Papers are in-depth articles aimed to educate and inform site visitors interested in medical research. Some of these papers are derived from sources where we have existing commercial relationships. Such articles are clearly labelled as sponsored content and are only accepted when the content is deemed to add value to the core editorial ethos of News Medical.

Seeing the forest for the trees: CMC and Regulatory Affairs

With ever changing guidelines for emerging biotech companies, it's important to see the overall picture of CMC and regulatory affairs.

From DSI, a PLG Company 22 Jul 2020

Accepting Appropriate Regulatory CMC Risk

Understanding the best ways to communicate between IND sponsors and the FDA during drug development can inform the appropriate regulatory CMC risk.

From DSI, a PLG Company 14 Jul 2020

Successful CMC Regulatory Affairs

Chemistry, manufacturing and control (CMC) regulatory affairs is a fast growing titan and must be approached appropriately during drug development.

From DSI, a PLG Company 14 Jul 2020

Drug Development CMC Considerations

Emerging Biotech companies rarely have a sizeable chmistry, manufacturing and controls group and so during drug development there is often not much thought put to CMC considerations

From DSI, a PLG Company 9 Jul 2020

FDA End of Phase II CMC Meeting Preparation

There are three rules of engagement recommended for the end of an end of phase II CMC meeting with the FDA. This article discusses this approach.

From DSI, a PLG Company 9 Jul 2020

A Short History of Gene Therapies

This article details the history of the differing types of gene therapies.

From OXGENE 1 Jun 2020

The Role of HEK293 Cells in Gene Therapy

This article details how gene therapy has been, and is still being, influenced by HEK293 cells.

From OXGENE 20 May 2020

Scalable Gene Therapy Manufacturing

This article discusses how OXGENE have produced a scalable gene therapy manufacturing process.

From OXGENE 20 May 2020

How Automation is Benefiting Gene Editing

This article details how scientists and robots are working together to transform gene editing solutions.

From OXGENE 20 May 2020

A Guide to CRISPR Patent Rights

This article details the history of CRISPR and the current patent rights for CRISPR treatment.

From OXGENE 20 May 2020

Future Applications of Gene Therapy for Heart Disease

This article discusses the possible uses of gene therapy for a number of cardiovascular diseases and ailments.

From OXGENE 20 May 2020

The Importance of In Vivo Genome Editing Treatment

This article discusses the world's first in vivo genome editing treatment, and how it could effect the future of medicine.

From OXGENE 20 May 2020

Developments of Quality Assured Automated CRISPR

This article details the history of genome editing, and the resulting quality assured automated CRISPR today.

From OXGENE 20 May 2020

Pharmaceutical Development and Formulation Considerations

During expedited pharmaceutical development, a balance of formulation considerations must be made between reliability, yield and cost.