Aldevron Breakthrough Blog

Streamlining Your cGMP Plasmid Manufacturing

April 16, 2025 by Aldevron

Continuous improvement to build efficiency

Words like “innovation” and phrases like “groundbreaking solutions” can sound intense. Yet, every improvement, no matter how big or small, in a product or process can be celebrated as a step in the right direction towards greater efficiency. That’s one benefit of joining the Danaher family of companies; a commitment to continuous improvement, via the Danaher Business Systems (DBS), which has been implemented into Aldevron’s manufacturing process.

DBS emphasizes innovation, reducing time to market, and delivering groundbreaking solutions. One of these innovative processes coming into play from Aldevron is EfficiencyDoc Batch Records for cGMP plasmid DNA manufacturing.

In the fast-paced world of clinical plasmid DNA production, efficiency and precision are paramount, which is why we understand the critical need for a streamlined approach to batch record documentation that can reduce turnaround times/time to market. With EfficiencyDoc Batch Records, we can help speed your manufacturing process by:

  1. Eliminating 6-8 Weeks of Preparation Time: Traditional batch records can take up to 6-8 weeks to prepare. With EfficiencyDoc, this preparation time is reduced to zero, allowing you to focus on what truly matters – producing high-quality plasmid DNA.
  2. Reducing Errors and Quality Events: By separating the batch record into three distinct parts – the lean batch record, work instructions, and a working tool – EfficiencyDoc minimizes the potential for errors and quality events in the batch record. This approach ensures critical information is clear and accessible, improving consistency and reproducibility.
  3. Being Audit-Ready: EfficiencyDoc is designed with audit readiness in mind. The streamlined documentation process ensures your records are always up-to-date and compliant with regulatory standards.
  4. Cost-effectiveness: EfficiencyDoc not only saves time but also reduces costs. By potentially eliminating the need for engineering runs and document generation fees, you can allocate resources more effectively and improve your bottom line.
  5. Continuous Improvement: Our system is built to support continuous improvement. With EfficiencyDoc, you can easily implement changes and updates, ensuring your manufacturing process remains at the cutting edge of efficiency and quality.

Join the Efficiency Revolution

At Aldevron, we’re committed to the highest standards in plasmid DNA manufacturing. Contact your Aldevron representative today to learn more about how EfficiencyDoc Batch Records can transform your production process and set you on the path to greater efficiency and success.

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ABOUT THE AUTHOR

Aldevron

Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin.