Downstream Processing

By considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.

ACF medium sped up cell-line development.

Microbial systems such as E. Coli and yeasts are most effective for producing antibody fragments.

How to maintain product stability and prevent particulates.

A prove-free system monitors accurately at very small scale.

Biodefense start-up companies have an abundance of options when seeking funding.

Can increase in ionic strength result in higher viscosity?

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.

A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.

In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics.

New techniques can greatly improve the MAb purification process.

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

Robust packing procedures can improve process performance and increase resin lifetime.

A close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.

Data on the performance and variability of different formats.

With virus-based production, vaccines can be available in 10-12 weeks.

The disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen.

This article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines.

Understanding the relationship between the process and CQAs.

A new method for MAb purification.

The development of a skilled labor force is essential for an expanding biopharmaceutical industry.

Using multivariate experiments to define acceptable ranges.

Results from a process developed for a commercial antibody.

FDA perspectives on specs and effective control strategies.

NeisVac-C is a polysaccharide-protein conjugate vaccine for use against Neisseria meningitidis serogroup C infection. The Phase 1 clinical formulation consisted of physiological saline, thimerosal, and aluminum hydroxide. The long-term stability data for both the PBS and saline formulations are presented in this article.

Interview with Roger Lias, president and group commercial director at Eden Biodesign, Inc.

This article discusses the production process of the major influenza antigen, hemagglutinin (HA), by rDNA methods in E. coli.

Interview with Magda Marquet, co-CEO and co-president of Althea Technologies

There are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.