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The Canadian Regulatory System for Cell and Gene Therapies
Viral Aggregation in Downstream Processing of Lentiviral Vectors
Understanding the Role of the Quality Unit in Good Manufacturing Practices
Planning Is Everything - Quality Control Testing in Cell and Gene Therapy
IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?
20 Jan 2022

Understand the Role of Computer System Validation in GMP Manufacturing

In a previous post on equipment qualification and validation, we outli...

08 Dec 2021

What Are Change Controls and Why Are They Important in GMP?

Good Manufacturing Practices (GMP) are built on documentation. A commo...

29 Nov 2021

Understanding the Role of the Quality Unit in Good Manufacturing Practices

The quality unit is an independent department, fulfilling quality assu...

03 Aug 2021

CCRM Collaborates To Tighten Timelines and Prepare Nkarta for IND Filing

CCRM works with customers in a collaborative manner to enable them to ...

27 Jul 2021

3 Ways Your CDMO Can Help You Avoid Supply Chain Problems

The COVID-19 pandemic has significantly disrupted supply chains and pr...

11 Dec 2020

4 Tips from the Experts: How to Tighten Your Timeline from Development to Trial

Responsibly moving a cell or gene therapy forward as quickly as possib...

01 Dec 2020

3 Considerations When Developing Your LVV Program

If you are looking to get a lentiviral vector (LVV) program off the gr...

12 Aug 2020

CDMOs: The Good, the Great and the Exceptional (and How to Tell the Difference)

Outsourcing to a contract development and manufacturing organization (...

27 Mar 2020

Essentials of Auditing in the Manufacturing of Cell and Gene Therapies

Our previous posts on quality management systems and steps to ensure y...

30 Oct 2019

Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant

When we think about cell and gene therapies (CGTs) what most often com...

24 Oct 2019

IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?

Understanding the cell and gene therapy (CGT) development process from...

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