BioProcess International webinar series to focus on optimising biologics manufacturing

Upcoming Late Stage Bioprocessing & Viral Vectors Digital Week running 2-11 November will address many goals and challenges associated with optimizing biologics manufacturing through different stages of the process

Sessions will include in-depth coverage of the advantages of process intensification to meet product demand and how smarter process choices can improve sustainability of facilities.

There is continuous interest in biopharmaceutical processing to increase productivity, facility flexibility and robustness whilst reducing operating costs, COGs and maintaining consistent product quality to improve patient’s lives. Many choices that are made during process development and manufacturing are made to work towards one or more of these aims.

The series will examine optimization of technology transfer across the product lifecycle for facilities and complex molecules as well as optimizing facility equipment with TPE tubing with an improved purity profile for faster qualification.

In order to excel in biologics many companies are choosing to partner with CDMOs to achieve their goals, it is crucial both sides are informed at every step and several companies will demonstrate the way to make the most out of this partnership.

There is an increasing trend in the biologics field which is moving towards novel modalities and companies will showcase challenges regarding sufficient expression, CMC strategies and facility design.

Many companies are looking at a range of ways to cut costs and one such method is to use a microbial cell line instead of mammalian. Benefits discussed in this webinar include producing correctly folded proteins with high yields and a lower COGs.

When it comes to quality of the finished product an important consideration is quality of the raw materials. This webinar will look at raw material management and liquid handling options to reduce contamination and delays.

The ultimate goal of any drug is to treat the patient and many formulations of APIs can initially cause discomfort or inconvenience for the patient, effecting quality of life. Silicone based excipients to achieve finished dosage forms which are more agreeable and easier to use will be showcased.

As you approach downstream processing the main challenge is maintaining product quality and one such attribute is virus filtration. As Upstream processes continue to achieve higher expression yields the pressure mounts on downstream processing to maintain quality and avoid aggregation. Different filtering methods and introducing automation into your process will demonstrate increased speed with reduced sample and reagent consumption.

The field of gene therapy is an expanding area with many choosing AAV vectors. However, one of the biggest challenges with AAV manufacture is the empty to full capsid ratio. In this digital week companies will offer their HPLC chromatographic solutions to assess the ratio during virus expression to optimise successful expression.

Included in the challenges of AAV manufacture is scaling up and quantity which are addressed with the revolutionary AAV platforms of several technology companies looking at transient expression efficiency, accelerated timelines and plasmid considerations.

When the product is the virus an important component of gene therapy production is viral safety, purity and product quality. You must distinguish you product from other unwanted viruses and remove impurities to prevent unwanted side effects. Novel purification and

A large portion of cell and gene therapy workflow is being borrowed from monoclonal antibody production and now needs to be optimised. Successful assays, analytical workflows and extended characterisation of viral vectors will be presented.

Register to attend the upcoming Late Stage Bioprocessing & Viral Vectors Digital Week running 2-11 November: