Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. In the United States, one of those channels is to have Pharmaceutical Sales Representatives ‘hand carry’ samples to the health care practitioners within their territories.
Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.
The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, we’ll demonstrate how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data through partnering with Fisher BioServices and Fisher Clinical Services.
Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.
Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.
Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries. BeiGene, a commercial-stage biotechnology company, can attest to these challenges.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Minimize errors, increase productivity and keep your laboratory’s resources focused on what matters most—positive patient outcomes—with the Thermo Scientific™ Arcos™ Block Management System.
The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.
Gibco BioProduction Services can support and partner with you no matter what your comfort level is with intellectual property. Our team of professionals will work with you to provide the best customized solution for your particular situation. You will receive exceptional customer service from start to finish.
Organizations need to manage chemicals safely from receipt to disposal along the entire lab-to-plant value chain, ensuring Environmental Health and Safety (EH&S) compliance across the enterprise.
This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.
