Aldevron Breakthrough Blog: Clinical Grade Manufacturing/cGMP

Perspectives: Hold on Tight for the Ride

A crazy, mixed-up world of cell & gene therapy in 2023

News concerning cell and gene therapy (CGT) may make you feel like you are on a rollercoaster. The ride moves very quickly with a lot of ups and downs, plus a few unexpected turns. As we move through 2023, excitement for CGT remains high, but there are lingering concerns about manufacturing and the ability of health care systems to keep up with the science.

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When Demand Gets Tough, Expansion Gets Going

Ongoing growth in CGT capacity

As the era of genomic medicine gains speed with the innovation of new technologies, we are at the forefront of genetic tools that can prevent, treat, or cure human diseases. It’s an exciting time, as during this early stage in developing new biological drug products, academics and industry are working closely to optimize cell and gene therapies (CGT) for a range of diseases. 

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Kaizen

The most important tool to support client success through lead-time reductions

Successful – for both Aldevron and our clients. That is how I would describe Aldevron’s first Shingijutsu Kaizen event and the first Danaher CEO Kaizen event of 2023, held the week of April 10. Not only did the efforts surpass all expectations but it surpassed deliverable goals--success!

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Streamlining the Drug Development Process

Aldevron expands mRNA  production capability

After years of service providers becoming more specialized, we’re now seeing a reversal in that trend. Enterprise offerings and solutions are on the rise, from consumer offerings to huge corporate deals. We can attribute this growth to an increased demand for simplicity of transactions, clear accountability, and building a win-win situation for both parties. 

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Webinar: How a Sponsored CMC Platform Accelerates mRNA Projects into the Clinic

Streamlining development, ensuring quality and safety

When discussing mRNA development, the complexity across a variety of modalities can give pause to how the projects should be approached and developed. With that in mind, Jon Cooper, Ph.D., Senior Director of RNA Sciences & Analytical Development recently presented, How a Sponsored CMC Platform Accelerates mRNA Projects into the Clinic, in this webinar and recently at the mRNA Analytical Development Summit in Boston, to provide an outline of an effective development process.

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Capacity versus Capability

What do they mean for you?

Capacity: The total amount that can be contained or produced
Capability: The ability to do something
*As defined by the Cambridge Dictionary

One of the issues I’ve heard raised in our industry is about how we define capacity and capability. As you can see from the definitions above, these are two very different items. But what do these two terms mean with respect to the manufacture of mRNA drug substance and/or drug product?

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Why Apply ISO 13485 Principles in a Protein Manufacturing Facility?

A stepping-stone in ongoing quality improvement

The ISO 13485 standard covers the quality management system (QMS) requirements for medical devices (like CT scanners, blood perfusion pumps, diagnostic IVD tests) including requirements for regulatory purposes. Certification is granted by a third-party registrar through an annual audit process with renewal every three years. Unlike global medical device governmental regulations, the ISO 13485 standard is the same whether you are manufacturing in Italy, Africa or the United States.
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Combining Resources to Streamline and Standardize Therapies

Academics and manufacturing making processes better

Witnessing firsthand the growth of cell and gene therapy to progress more programs to the bedside is an exciting time in the biotechnology industry, particularly with new partnership approaches being developed. I was able to get an overview of one particular partnership during a podcast featuring Tom Foti, VP of Protein Business unit at Aldevron, and Kris Saha, Ph.D., Associate Professor of Biomedical Engineering, Medical History and Bioethics at the University of Wisconsin.

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Four Major Steps Involved in mRNA Manufacturing

From potential to solution

For more than two decades, in vitro transcribed (IVT) messenger RNA (mRNA) has been considered for its potential to address unmet medical needs and to transform the development and manufacture of medicines. This potential was suddenly realized by the unprecedented response to Covid 19, ushering in a new era in the application of mRNA technologies to solve challenging health problems.

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