To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
There are a number of reasons to choose LBDDS over conventional formulation approaches when working with poorly soluble compounds. However, the range of lipidic excipients and the abundance of factors that go into determining which combinations of lipids, cosolvents, and surfactants to select makes LBDDS a complex, formulation-dependent technology. Know what criteria to consider when selecting a CMO to handle LBDDS manufacturing.
Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet those diverse consumer preferences and potentially extend product lifecycles.
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharma production.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.
3D printing allows drug companies to not only boost efficacy and adherence but also contribute to their brand longevity by expanding and capturing market share with other dosage form options.
The properties of the particles that make up a pharmaceutical powder directly affect its behavior, a classic example being that finer particles are usually associated with poor flowability. However, so too do other ‘system’ variables, such as the degree of aeration or consolidation. The analytical toolkit required for the knowledge-led control of formulation properties therefore necessarily extends from particle characterization through to bulk powder testing techniques. Particle characteristics are the levers manipulated to meet performance targets, but bulk powder properties often define some of these targets. Marrying the results from both types of analysis is often the key to efficient progress.
Leveraging external experts for analytical input provides a cost-effective route to the latest instrumentation, robust and precise measurement, and reliable data interpretation.
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