02.16.23 -- CGT Manufacturing: Risk Vs. Benefit

Explore this discussion among experts about how to develop robust, scalable, and cost-effective processes that yield high titers of high-quality viral vectors.

Improving the overall stability of cell complexes represents one of the key process improvements necessary to achieving reproducible, scalable lentiviral transfection.

Examine how RMM differs from traditional microbiologic methods that rely on lengthy incubation periods and understand why there is a shift favoring RMM for pharmaceutical manufacturing.

We offer useful insight into methods and collection options for process sampling, as well as how each fits based on assay type and process stage.

An effective partner must possess the necessary unique analytical capabilities for LNP characterization and the ability to support clients from concept to commercialization.

Discover how effective site monitors drive open communication, information-sharing, and a mutual understanding of the other party’s challenges conducive to fruitful site relationships.

We review the four key elements to a capital project report — cost performance, schedule performance, risk management, and resource management.

In this blog, we compare pharmaceutical cleanroom modular installation to the leading alternative, stick built construction.

When a new product, technology, or supplier is selected during the development and design phase of the biological manufacturing process, manufacturers must assess the supplier’s own supply chain and beyond.

Newer technology is now available that solves the problems of conventional cell counting methods and may better help with manufacturing and quality control of CTPs.

For small lot sizes of 50 doses per lot, QC costs can run even higher, at more than 50%. These high costs are due in large part to the significant manpower needed to review hundreds of pages of batch information before the batch can be released. Release by exception is a review approach where quality teams would review information only when preestablished targets are not met or certain alarms are triggered. This means that products can be released automatically unless pre-defined metrics are not met.

The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring comparability study preparation.

A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill/finish.

The rate of cell & gene therapy (CGTx) advancement over the last decade can seem like we’ve entered the realm of science fiction. The complexity of the field requires the right tools and guidance to navigate the CGTx path to making the fantastic a reality in the form of new treatments for patients. With more therapies progressing toward approval milestones and the constant striving to improve technology, staying up to date with progress in the field is as important as ever, especially in areas like regulatory pathways, novel technologies, and CMC and manufacturing trends.