In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.
Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.
Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.
Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.
Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.
This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.
Choosing an offsite storage facility means asking the right questions, to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location.
If you have asked and answered these five questions, and are using a rigorously designed and qualified shipping system, then the data will provide an objective affirmation that you performed due diligence and significantly advanced the commercial success of your product.
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.
The SIMULIA Living Heart Human Model provides a unique testing environment where a pacemaker lead can be virtually inserted and mechanically deformed during the cardiac cycle. Once the mechanical deformation results are obtained, the long-term durability of the implant can be assessed. The virtual nature of the test provides a physiologically accurate methodology to test new and existing devices without exposing patients to un-necessary risk.
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.
This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.
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
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.
