The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here, insights around the challenges in viral vector manufacturing are shared so that a scalable and cost-efficient process suitable for GMP manufacturing environments can be obtained.
Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.
Today multiple suppliers offer commercial process solutions for continuous cell culture, continuous clarification, continuous chromatography, continuous virus inactivation and continuous filtration and their effectiveness is documented in the technical literature. So, what’s next? We have the tools; the technology is proven and early adopters are active.
Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.
Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
Today’s biologics pipeline is healthy, but near-term forecasts indicate growth so robust, the industry risks being ill-equipped to meet demand. Can biopharma count on contract manufacturers to rise to the demand challenge?
The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.
Scale-up and technology transfer of lyophilization processes remain a challenge, but recent advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.
Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
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