Due to its immense adaptability, extrusion has been widely utilized in diverse fields. It is being adopted more recently by the pharmaceutical industry at an unprecedented pace to address various drug product formulation and manufacturing needs. Read more about this exciting yet complex technology and the many advantages it offers.
A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.
This article is a recent discussion with the General Manager of Pfizer CentreOne, regarding the what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.
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.
The availability of single-use equipment and components is growing rapidly and has forced unit prices down. In addition the usability and reliability of these systems has increased markedly.
The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here, 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.
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