While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.
Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use. The process economy comparison performed in this work was made for the preparation step of Cytodex 1 versus Cytodex 1 Gamma microcarriers. Two scales were included: 100 L pilot and 500 L production scales.
This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine. Histidine-tagged rPA was produced in Pseudomonas fluorescens grown in the singleuse Xcellerex XDR-50 MO fermentor system.
This application note discloses process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless steel and single-use configurations across various production scales and scenarios. The process based on modern tools and technologies was generally shown to be the most cost-efficient option of the investigated alternatives. Process configurations using single-use equipment wherever possible were also shown to be more cost-effective than corresponding configurations using primarily stainless-steel equipment.
This application note describes a process for adenovirus production, from upstream cell culture to downstream purification, using modern tools and technologies. To demonstrate robustness of the upstream process, virus production in suspension adapted cells was performed in both rocking and stirred-tank bioreactors. The downstream process was carefully optimized to meet stringent regulatory demands on product purity and quality. Novel analytical methods were used in parallel with established techniques for comparison and to ensure accurate monitoring of the processed material. The novel process is easily scaled and compatible with both single-use and steamable hard-piped process equipment.
The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
Achieving high drug load with rapid dispersion using 3D printing.
Having a solid understanding of the most common API challenges can help to avoid development delays, rework or outright failure.
Leading Analytical Scientists with Advanced Instrumentation.
PerkinElmer Signals™ Notebook is a powerful new web based Electronic Lab Notebook, enabling users to instantly author and manage notebooks and experiments, facilitating Scientific Collaboration.
Developed with Aprecia’s proprietary 3DP manufacturing process, ZipDose® Technology helps patients who need medicines that are easy to take and caregivers—including physicians and nurse practitioners—who want medicines that are easy to administer. By enabling delivery of high-dose medications in a rapidly disintegrating form, ZipDose overcomes patient adherence and difficulty swallowing challenges.
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
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.
