By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
A larger-scale adoption of single-use technology may continue to be delayed as biopharma manufacturers must have access to a reliable supply chain that successfully delivers product to customers.
The concept of Genotoxic Impurities (GI) and Potential Genotoxic Impurities (PGI) is defined in the ICH M7 (2014) and EMA (2006) guidelines. The focus of these guidelines are on DNA reactive substances – those when present at low levels have a potential to directly cause DNA damage and lead to mutations, thereby potentially causing cancer. For late stage compounds and marketed products, acceptable increased cancer risk is set at a theoretically calculated Threshold of Toxicological concern (TTC) level of 1.5 mg/day.
There are several factors that biopharmaceutical companies should take into account when considering outsourcing primary packaging. This article provides an in-depth look at the benefits of developing packaging strategies as early as possible in the drug development process, how primary packaging should be approached to ensure patient compliance, and different forms of packaging that best protect and improve the stability of a product.
There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?
An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering. Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective. What should we expect to see from industry and academia to keep the field moving forward?
In the rush to market, be aware of these critical missteps that can occur during the early development phases, in order to avoid major challenges later during commercial API scale-up.
Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.
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