Latest Whitepapers

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.

Ultra-high performance liquid chromatography (UHPLC) involves utilizing columns with submicron-sized particles and high-pressure flow, resulting in enhanced resolution and sensitivity when dealing with complex sample mixtures. Mass spectrometry (MS) plays a vital role in detecting and identifying analytes even at concentrations as low as parts per trillion.

Liquid chromatography mass spectrometry (LC-MS) plays a pivotal role in the precise analysis of trace molecules. To enhance sensitivity and accuracy, it is crucial for researchers to upgrade from HPLC-grade solvents to LC-MS grade solvents that are specially designed to meet the stringent requirements of modern LC-MS systems.

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.

This whitepaper highlights the key molecular components of ADCs and the challenges and opportunities for their future development.