The growing adoption of single-use (SU) in all process steps of cGMP clinical and commercial production requires enhanced assurance of supply and robust product performance. This innovative bioprocessing bag technology is designed to meet the new challenges of assurance of supply and consistent performance for every process step and application of biomanufacture.
The growing adoption of single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.
Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are towards higher cell densities and protein titers.
Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise. Drawing on existing ICH guidelines, a recent publication co-authored by AbbVie suggests a science-based approach that can be applied to the design of an effective control strategy for small molecule impurities in ADC therapeutics.
Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.
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