Tubing is arguably one of the earliest components in the pharmaceutical industry to be associated with single-use technology (SUT). Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the following development principles should take place.
Companies are moving from stainless steel to single-use assemblies for final filtration allowing them to meet production demands and cut costs. The design of single-use assemblies can be challenging. Learn more about the different options that should be considered to accommodate pre-use integrity testing along with prototype testing and handling considerations.
A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.
Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed and how one CDMO, Singota Solutions, has positioned itself to meet these challenges.
A small, research-focused biotechnology company received incredibly positive results in the clinic for their current program and was instructed by leadership to push ahead quickly with an aseptic fill for another trial. They urgently needed help to get their finished drug product clinical supplies to their distributor by December to make it in the clinic by January 2020.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
An organized effort across the biopharmaceutical industry, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed and mitigated to assure consistency of performance and minimize likelihood of contamination. Without the proper risk mitigation, problems can arise which may ultimately compromise product quality, shutdown production or potentially impact patient safety. This whitepaper describes considerations for selecting a vendor to support your media preparation workflow, and will discuss approaches to minimize variability and de-risk steps.
It’s difficult to find reliable, efficient single-use liquid sensor technologies that overcome current measurement challenges necessary for maintaining product quality while meeting process development schedules. Read how The Rosemount's single-use sensors provide the same proven stability and performance as traditional stainless steel technologies and are uniquely adapted to fully meet the needs of the single-use biopharmaceutical manufacturing environment.
Rosemount 550DW single-use dissolved oxygen sensor adapter is compatible with standard stainless-steel DO sensors, currently validated with the Rosemount Hx438, and enables placement into the bioreactor single-use bag. Only the gamma-irradiated adapter touches the process solution, meaning the sensor can be reused for multiple batches. The sensor can be air-calibrated prior to start-up to verify functionality with no fill product needed in the bioreactor. Shelf life is two years.
Rosemount 550pH sensor is designed to provide high measurement stability for single-use bioprocessing applications. The sensor stability of <0.005 pH change per day enables users to do a one-point calibration at the start of the batch and operate for 30-days without any required maintenance or recalibration. The unique capability of being stored wet significantly increases shelf life to two years and allows immediate verification and calibration eliminating the initial stabilization process.
Rosemount 550pH sensor is designed to provide high measurement stability for single-use bioprocessing applications. The sensor stability of <0.005 pH change per day enables users to do a one-point calibration at the start of the batch and operate for 30-days without any required maintenance or recalibration. The unique capability of being stored wet significantly increases shelf life to two years and allows immediate verification and calibration eliminating the initial stabilization process.
Rosemount 550DW single-use dissolved oxygen sensor adapter is compatible with standard stainless-steel DO sensors, currently validated with the Rosemount Hx438, and enables placement into the bioreactor single-use bag. Only the gamma-irradiated adapter touches the process solution, meaning the sensor can be reused for multiple batches. The sensor can be air-calibrated prior to start-up to verify functionality with no fill product needed in the bioreactor. Shelf life is two years.
