血浆组分分离

Ease of administration and high dose applications are driving the bioprocessing industry to formulate higher concentration biotherapeutics.

The plasma industry is looking for process improvements to develop new formulations and dosages with higher concentration for subcutaneous administration, such as for Immunoglobulin.

The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters.

We will focus on aspects of new product and system design that help customers meet regulatory expectations and reduce contamination risk while maximizing product recovery.

In this webinar we describe a filtration model and test methodology to rapidly and efficiently design an optimal dual-stage filtration process.

This webinar summarizes filter design, criteria for filter selection, and how new filter choices can maximize your productivity.

In this webinar, you will learn to understand the impact of uncontrolled bioburden, identify bioburden sources, and develop strategies to mitigate risk.

This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.

Single-use pharmaceutical manufacturing has been widely adopted in development and clinical manufacturing. Even though these disposable technologies offer various benefits, there are still some challenges based on a lack of standardization of quality tests and procedures.