As the impact of extractables and leachables on product stability gained greater visibility in relation to single-use technology (SUT), GE Healthcare and Sealed Air formed a partnership to address the issues with the current film structures in today’s biopharma market.
Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point.
Biomanufacturers seeking a place in a competitive and lucrative future must start engaging in change now to meet the demands for delivering drugs more quickly to the patients who need them.
This article discusses four topics related to single-use bioprocessing which are commonly cited by end users as amenable to future development.
A client was exploring the possibility of re-purposing an internal collection of antifungal CYP51A1 inhibitors for targeting cancers. GVK BIO was commissioned to enable the such project. Learn how a CYP51A1 inhibitor screening assay using the RapidFire HTMS method was deemed to be optimized, and screening of client compounds was enabled with an acceptable throughput and in a cost-effective manner. This project then went on to yield high potency compounds for the client which allowed them to further their drug discovery plans.
The failure rate for new drugs targeting important CNS diseases in general have higher failure rates than the other diseases, both preclinically and clinically. Pharmacokinetics of the drug along with the drug delivery mechanisms play an important role in determining the success of new CNS drug because blood-brain barriers (BBB) limit the entry of molecules into the CNS. This paper discusses some successful PK approaches that we have employed in the recent past and may help in CNS targeted drug discovery and development efforts.
Despite over 50 years of research, there remains no licensed vaccine product and disease due to RSV infection remains an unmet medical need. In vitro & in vivo models for RSV vaccine development can provide a critical component in development of anti-RSV antibodies, small molecules and vaccines. Learn how customized and high quality pre-clinical animal models and ex vivo readouts can support your anti-RSV biologics development from concept all the way to IND.
Bleomycin-induced pulmonary fibrosis has been a useful pre-clinical model in several species and is most prevalent in rodent models to evaluate potential prophylactic and therapeutic drugs for IPF. The induction and progression of the disease in rodents is of a short duration, making it a practical model for evaluating test compounds in preclinical research. Major drawbacks for this model have been its mortality rate and inconsistency in the induction of the disease. Access to a large portfolio of in vivo fibrosis models allowed for successful drug testing.
To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.
Today multiple suppliers offer commercial process solutions for continuous cell culture, continuous clarification, continuous chromatography, continuous virus inactivation and continuous filtration and their effectiveness is documented in the technical literature. So, what’s next? We have the tools; the technology is proven and early adopters are active.
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