Latest Whitepapers

This whitepaper highlights how monitoring critical parameters with a 24/7 real-time, data-acquisition system can remove variables from experimentation, mitigate risk and increase research reproducibility.

This whitepaper highlights essential factors to consider for the successful manufacturing of gene and cell therapies.

High-intensity, high-volume cell cultures are an essential part of many bioproduction workflows – especially those operating at scale. However, aggregate accumulation, batch-to-batch cleaning and extensive sterility validation can all negatively impact overall workflow efficiency.

The preparation of process liquids and buffers for in-house bioprocessing can be complex and face many logistical challenges. Additionally, a failure to optimize operational efficiency can result in supply chain disruption, total cost of ownership (TCO) and quality control challenges.

This case study highlights how a CDMO at risk of a facility shutdown solved severe supply disruption problems with the help of an experienced sourcing service.

Single-use fermenters (SUFs) use disposable sterile plastic bags that don’t require the traditional high-intensity preparation of SS bioreactors, which are expensive and time-consuming processes.

Adeno-associated viral vector (AAV) has become a preferred gene therapy delivery modality; however, AAV manufacturing is not without its challenges, whether that is using crude samples, a lack of standardized methods or incompatible techniques.

Despite the success of AAV for gene therapies and vaccines, many challenges still exist within AAV manufacturing. To ensure the safety and efficacy of a therapeutic, it is crucial to accurately determine the percentage of capsids that carry the gene of interest.

A scalable and robust solution for all stages of the gene therapy workflow to meet regulatory standards is essential, however, as the field is more recent, liquid media is the common format even though it can be more expensive and have a shorter shelf life.

Whether scaling up production in-house or using a contractor there are many factors to consider. This whitepaper outlines how outsourcing process development to an experienced provider can improve workflow efficiency and reduce overall costs.