4SC AG, a clinical-stage biopharmaceutical company partnered with Patheon, by Thermo Fisher Scientific, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based in the US and the investigational medicinal product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU. This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.
Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.
Biopharmaceuticals tend to be highly unstable. A pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage, according to Yunsong (Frank) Li, director of process development at Catalent Biologics, in this Pharmaceutical Technology interview.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.
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.
Leading Analytical Scientists with Advanced Instrumentation.
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.
The ZE5 Cell Analyzer is an innovative new flow cytometer with flexible configurations to meet a broad range of experimental complexities and throughput needs. Whether it’s a low-complexity, or a high-complexity experiment, the ZE5 Analyzer has up to 30 parameters and provides a truly expandable flow cytometer. This flexibility makes the ZE5 Analyzer accessible for novice flow cytometry users yet flexible enough for the most experienced flow cytometry professionals
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.
