Tuesday, June 21, 2022 Daily Archives

Pressure Vessels for Biomanufacturing: Basic Considerations for Cleaning and Process Compatibility

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Pressure vessels are enclosed containers used to contain liquids, vapors, and gases at pressures that are significantly higher or lower than the ambient pressure of their surroundings. Equipment such as bioreactors, holding tanks, mixing tanks, separators, and heat exchangers all are examples of pressure vessels. As such, they form an integral part of biopharmaceutical manufacturing. Apart from pressure containment itself, a key challenge in building pressure vessels is making them meet the high purity and cleanability requirements of bioprocessing. As…

June 21, 2022

Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates

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Messenger RNA (mRNA) emerged as a powerful therapeutic tool for treatments in gene therapy, oncology, and infectious diseases, as recently demonstrated by vaccines against Covid-19. mRNA is produced by an enzymatic reaction that can be rapidly designed and scaled-up, and the platform is highly adaptable to different targets. One of the greatest challenges in mRNA production is the removal of process-related impurities stemming from in vitro transcription (IVT) reaction, such as residual nucleotide triphosphates, DNA template, enzymes, abortive transcripts. Affinity-based…

June 21, 2022

Biologics Manufacturing Without the Big Bioreactors

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Over the past few decades, the biotechnology industry has brought to patients a medical revolution with the most advanced medicine ever seen. Yet much of the world’s population cannot afford or get access to these breakthrough therapeutics. That is in part a consequence of the high associated costs of development and biomanufacturing, extended times for regulatory review and approval, and a lack of regional manufacturing and dependable supply chains (because of facility costs and a scarcity of expertise). The recent…

June 21, 2022

Ask the Expert: Using Monolith-Based Chromatography to Monitor In Vitro Transcription Reactions

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In vitro transcription (IVT) is a critical step in messenger RNA (mRNA) production. In a March 2022 webinar, Rok Sekirnik (head of process development for mRNA and plasmid DNA (pDNA) applications at BIA Separations, part of Sartorius) explained that optimizing concentrations of reagents used during IVT helps to maximize the amount of mRNA that is produced. Drug developers have great need for analytical methods that can measure IVT in real time. Sekirnik showed how CIMac PrimaS monolith chromatography columns enable…

June 21, 2022

Ask the Expert: Using High-Throughput Analytical Systems to Facilitate Binding-Kinetics Assays

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Critical quality attributes (CQAs) must be characterized thoroughly to establish a biopharmaceutical’s potency, efficacy, and safety. Such characterization involves some of the most difficult analytical activities that are performed in a biologic’s product life cycle. There is great need for analytical tools that can facilitate such studies. In March 2022, Dr. Kalhari Silva (head of scientific research at Custom Biologics) and Dr. Bob Dass (senior scientist at Sartorius) joined BPI to describe how Octet biolayer interferometry (BLI) technology can be…

June 21, 2022

Managing Manufacturing Requirements for Live Biotherapeutics

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In 2018, Synlogic explored options for producing clinical-trial material for its lead programs, including a candidate therapy for the rare metabolic disease phenylketonuria (PKU). Like other emerging drug developers, the company evaluated the merits of outsourcing manufacturing to third parties. However, Synlogic leverages synthetic biology tools to design and develop therapeutics based on genetically engineered microbes. Thus, it also needed to consider requirements specific to live biotherapeutics. Late in 2018, Synlogic announced plans to establish its own current good manufacturing…

June 21, 2022

Pfizer takes $95m stake in Lyme disease vaccine partner Valneva

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The Equity Subscription Agreement will see Pfizer take an 8.1% share of French vaccine developer Valneva and increase its support of Lyme disease vaccine candidate VLA15. According to Valneva, VLA15 is the only active vaccine program in clinical development against Lyme disease – a vector-borne illness transmitted to humans by infected Ixodes (aka deer or blacklegged) ticks. The multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A…

June 21, 2022