Ensuring a Consistent, High-Quality Biologic Drug Process Development 

The development process for a biologic is generally divided into cell line development, upstream and downstream development, manufacturing, and formulation development, where each development process holds its own purpose along a biologic’s journey to commercialization.   In this article we are going to answer some questions related with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development...
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How to increase unstable protein expression in E. coli

Recombinant protein expression and purification for therapeutic development or for in vitro studies can sometimes be a real challenge, because it requires huge investments in both time and cost in order to obtain high yields. The objective of this article is to give you a simple guide to easily establish optimal conditions for recombinant protein expression and production in E. Coli, which is the most widely used protein production system, of problematic unstable proteins of interest...
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Characterization and Validation for Biologics

Monoclonal antibodies and next-generation therapeutics need a more complex manufacturing process than a simple enzyme. For those molecules you need to assure their quality attributes and safety profile. In this article, we are going to explain how this validation process is done.    Understanding Process Risks  Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization.  At this stage, multiple candidate molecules may be screene...
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Upstream Optimization for Plasmid DNA Manufacturing

Plasmid DNA manufacturing is increasingly needed. The pDNA-based cell and gene therapies treatments emerging in both industry and academia are growing. The need for novel treatment options to combat cancer, metabolic disorders and other infectious diseases is increasing on a global scale.   In this article, we will analyze the scalable process workflow solutions available for plasmid DNA manufacturing, from initial R&D investment to clinical testing, and commercialization. We will focus on...
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CMC Strategy for mRNA Manufacturing 

There is no question that mRNA mannufacturing is not easy. Besides testing their safety and efficacy, biopharmaceutical companies must also design a protocol for scaling and manufacturing the drug for regulatory approval and commercial use. This creates an immense pressure to expeditiously develop streamlined chemistry, manufacturing and control (CMC) strategies.  That is why in this article we will explain what a CMC strategy is and the challenges in the mRNA manufacturing.   What is CMC Deve...
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Plasmid DNA Production for Cell and Gene Therapy – Q&A

In cell and gene therapy manufacturing, high-quality plasmid DNA is a key component. The demand of high-quality plasmid DNA has increased and this has led to the need to optimize the manufacturing and the quality required for use in the manufacture of therapeutics. However, the plasmid DNA (pDNA) manufacturing faces several challenges like: Its large size. The shear sensitivity. The high viscosity. The similarities between the pDNA and the impurities present during manufacturing. This makes impo...
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