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The Unique Properties of Gelatin in 3D Bioprinting

How to select the right bioink to secure proper cellular characteristics and functionalities in engineered tissues: exploring the benefits of low endotoxin gelatins. Gelatin has long been a trusted excipient in the pharmaceutical industry. For advanced biomedical applications like in-body use, there are strict regulations for endotoxins levels of the final product (medical device) to avoid unwanted side-effects. 3D bioprinting is a very popular tissue engineering technology used in the field of regenerative medicine. In this whitepaper, we explore the…

Podcast: Lumen using spirulina to make ‘edible’ antibody drugs

We sit down with Lumen Biosciences CEO Brian Finrow to discuss how his company hopes to use its spirulina-based platform to develop drugs targeting gastrointestinal disorders. Lumen Biosciences is a biotech looking to unlock the full potential of biologic drugs, whose promise has been held back by the lack of scalable technology. The firm is developing ‘oral antibodies’ using its platform based on spirulina– the protein-rich cyanobacteria touted by many health enthusiasts as a ‘superfood’ – to create tiny factories…

eBook: A Dynamic Control Strategy for Downstream Continuous Bioprocessing

Continuous processes can have many sources of variability. In downstream unit operations, changes can arise because of feed material variability, resin fouling in chromatography columns, column compression or failure, membrane fouling, depth-filter clogging, and so on. The US Food and Drug Administration’s guideline for continued process verification encourages biomanufacturers to monitor their processes and keep them under a steady state of control. One way to achieve that in continuous downstream processes is to implement a dynamic control system that adapts…

Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

The application of plant-based systems to produce biopharmaceuticals for human and veterinary indications is a rapidly expanding field. Available systems range from stable transgenic root-cell culture to transient expression in whole plants. Products that have been expressed include monoclonal antibodies (MAbs) (1), subunit vaccines (2), virus-like particles (VLPs) (3), specialty enzymes (4), and structural proteins such as collagen (5). “Traditional” bioproduction platforms such as Chinese hamster ovary (CHO) cells, Escherichia coli, and Pichia pastoris have long histories of patient safety…

Cold Chain Excellence: Getting Control Over Freezing of Biologics

HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front…

The Impact of Protein Stability on Virus Filtration

Filtration of protein-based biologics is essential for minimizing viral contamination and ensuring product safety and high quality. The tendency of therapeutic monoclonal antibodies (MAbs) and recombinant proteins to aggregate under a number of conditions can complicate selection of a virus filter. An increasing demand for high concentration formulations creates additional challenges. When performing filterability studies and to ensure meaningful virus filter evaluations, downstream process scientists must address factors that can lead to aggregation. This special report on virus filtration by…

The CRISPR Saga (So Far)

Since January 2016 (with a brief interlude as described below), the Patent Trial and Appeal Board has been attempting to adjudicate the proper inventorship of CRISPR technology in (to date) six separate patent-interference proceedings. (Scientific “priority has been decided, for now, by the awarding of the Nobel Prize in Chemistry to Jennifer Doudna and Emmanuelle Charpentier in 2020; see the “Priority Claims” box). CRISPR-based gene editing was hailed as the “Breakthrough of the Year” in 2015 (1), and the scientific…

Scaling AAV Production: Easing the Transition from Laboratory Scales to Commercial Manufacturing

Adenoassociated virus (AAV) has emerged as the leading vector for gene therapy delivery. Compared with options such as lentivirus and adenovirus, AAV exhibits a strong safety profile because it has low pathogenicity and requires a helper virus to replicate. AAV is also capable of long-term gene expression, and it can infect both dividing and nondividing cells (1–5). Developers of advanced therapies have found such advantages to be quite attractive. As of January 2021, two gene therapy products have gained US…