Aldevron Breakthrough Blog: Protein

Rocking in the E. World

Why E. coli rocks

Commonly, when a person hears about Escherichia coli (E. coli), the news is negative. But it’s only a specific strain of E. coli detected on food that wasn’t cleaned or stored properly that’s a health hazard. When it comes to biotech, however, E. coli rocks! It’s been the workhorse for the creation of a multitude of products due to:

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An evolution at TIDES

mRNA joins the mix

In the past, the TIDES USA conference event has been focused on oligonucleotide and peptide therapeutics, providing information on development trends and technologies for those industry segments. That is changing now, with an additional focus on mRNA therapeutics coming into the mix. 

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Protein Expression for Vaccine Development

Overcoming challenges in process design

Recombinant proteins are an essential component of many vaccines. However, producing these crucial proteins can be challenging. From selecting the appropriate expression system to optimizing fermentation and purification processes, there are many factors to consider when designing a process to make high-quality proteins that can be used for vaccine development.

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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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Connecting on CRISPR

Innovation from the CRISPR 2022 Meeting

When it comes to gene editing technology, there are few meetings as valuable for us and our collaborators as the annual CRISPR meeting. Academic in focus and highly technical in nature, the 2022 edition of this event came to Boston, packing more than 40 lectures and 120 posters into a rapid-fire, three-day learning experience.

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DMFs for CRISPR

Applying an old concept to CRISPR applications

Historically speaking, drug master files (DMF) have been used in filing Investigational New Drug applications (IND). However, they’ve never been used for CRISPR because that’s a relatively new therapy. With new draft FDA guidance relating to cell therapies using CRISPR, we’re moving further ahead into a new frontier of genomic medicine.

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How New FDA Guidelines Can Affect Cell Therapy Development, part 2

The effect on autologous and allogeneic therapies projects

In my previous post on new draft FDA guidelines that concern cell therapies, I covered key control considerations for CRISPR reagents and the GMP manufacturing considerations for drug substances affected by that guidance. In this post, I’ll go over a couple approaches to consider when working with gene-modified cell therapies, and how they could be affected.

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How New FDA Guidelines Can Affect Cell Therapy Development, Part 1

Defining control considerations for CRISPR reagents is key

The FDA recently released draft guidance on Investigational New Drug (IND) applications for Human Gene Therapy Drug Products Incorporating Human Genome Editing technology to edit human somatic cells. This much-anticipated draft highlights manufacturing, quality, and regulatory considerations for drug developers preparing IND filings for novel, gene-modified cell therapies.

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