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Viral Aggregation in Downstream Processing of Lentiviral Vectors
IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?
5 Considerations for Scaling-Up PSC-Derived Cell Therapies
Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant
Planning Is Everything - Quality Control Testing in Cell and Gene Therapy
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...

07 Oct 2021

Environmental Monitoring in the Manufacturing of Cell and Gene Therapies

Environmental monitoring (EM) is an important laboratory control that ...

24 Sep 2021

Tips for Managing GMP Manufacturing Timelines

Managing timelines is a shared challenge for contract development and ...

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...

09 Jun 2021

Scaling-Up Production of Pluripotent Stem Cells Part 2 – Key Considerations for Successful Scale-Up

In Part 1 of this series we covered some basic definitions and reviewe...

21 May 2021

Scaling-Up Production of Pluripotent Stem Cells Part 1: Begin with the End in Mind

Many emerging cell and gene therapies are aimed at using cell replacem...

12 May 2021

How CCRM's Unique Approach Enables Client Success

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

04 Mar 2021

5 Considerations for Scaling-Up PSC-Derived Cell Therapies

A core regenerative medicine approach is cell replacement for the repa...

20 Jan 2021

Solving the Technical Challenges in Gene Editing of Induced Pluripotent Stem Cells

In a previous post we provided an overview of induced pluripotent stem...

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