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.
Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
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.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
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 of 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.
Data-driven risk assessment enables smart decisions on development strategy.
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
This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.
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.
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.
