Ensuring Good Manufacturing Practices for Cell & Gene Therapies

Ensuring Good Manufacturing Practices for Cell & Gene Therapies: A 10-Point CQV Checklist

With the boom in demand and production of cell and gene therapies (CGT) over the last decade, biopharma manufacturers are continually adapting to capitalize on market trends and address necessary equipment and facility upgrades.

Manufacturers that can strike the right balance of technology, personnel, and partnerships can overcome the CGT market limitations and growing pains to establish and maintain good manufacturing practices (GMP) and capitalize on the market trajectory.

Download this white paper to explore the current state of the U.S. CGT market and review ten commissioning, qualification, and validation strategies CGT companies can use to ensure GMP compliance.

Guide to Maintaining Validation of Older Facilities

Guide to Maintaining Validation of Older Facilities: Why, When and How

There is no definitive guidance for the lifespans of specific equipment, utilities, and systems that make up manufacturing facilities — and aside from cleaning/sterilization equipment, very little guidance regarding how often each needs to be validated and maintained to comply with changing industry standards and production trends.

This guide explains some of the most common challenges found in aging facilities, tips for identifying when a facility requires revalidation, and how to assess aging facilities, utilities, systems, and equipment for revalidation or maintenance needs.

Download this white paper to learn why, when, and how to maintain validation of aging facilities.

Data Integrity: How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics

5 Practical Ways to Proactively Avoid Data Integrity Issues for Improved Quality

Pharmaceutical and biotechnology companies are no strangers to FDA 483s and warning letters. In fact, the categories of Devices and Drugs accounted for the second- and third-most 483s issued by the FDA in 2019. Although not the top source of 483s, issues related to data integrity were responsible for a significant portion of 483s in these categories as well as in the growing field of Biologics.

Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked. Download this white paper to learn five ways to address data integrity and process issues to minimize 483s and warning letters.

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