This case study examines the benefits and challenges Nephron Pharmaceuticals Corporation faced integrating a STERIS VHP® Biodecontamination system into their high-volume compounding facility.
A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
Creativity and collaboration are required to overcome complex method development challenges.
Webinar Date/Time: Thu, Jun 20, 2024 10:00 AM EDT
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
Continuous SEC was shown to increase productivity with the same product quality and yield.
Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
A step-by-step path to building confidence in packaging component selection for injectable drugs
Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.
Gene therapy products present a unique set of challenges for the control of host cell protein impurities.
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Assessment of peripheral blood protein glycosylation has recently become scalable, providing a new domain for biomarker research.
In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
Start-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.
A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
Scaling cell therapy production workflows requires the establishment of closed, automated steps.
Continuous SEC was shown to increase productivity with the same product quality and yield.
A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
Frontage Laboratories' Marianna Tcherpakov, PhD, director of Business Development, CMC Services, discussed the CDMO’s role in enabling startup biotechs solve complex technical challenges for scale up.
Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
Webinar Date/Time: Thu, Dec 1, 2022 11:00 AM EST
A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.