The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters.
SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.
When you don't know the answer to a question, ask an expert. If the question is really big, ask more experts. If you have a collection of difficult questions, run a poll of many experts. That, in effect, was the impetus for Eden Biodesign to survey 670 BioPharm International subscribers with questions as to what will be the development mechanism to achieve safe, effective, and cheap new medicines.
Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.
The drive to develop better, faster, and smaller - in other words, more efficient - products is a universal trend in the modern world. This trend has profoundly impacted many industries from microelectronics to packaging equipment. In the biopharmaceutical industry, the need to speed and simplify the long and complex drug manufacturing processes brings additional challenges, such as meeting regulatory requirements.
Manufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Protein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
By Rajiv Nayar and Mark C. Manning, HTD Biosystms, Inc., pp. 20-28. Outsourcing is often considered a way to expedite drug development, but other options exist for companies that don't choose it yy} or that run up against the capacity shortage. The resources devoted to speeding up the drug discovery process led to combinatorial libraries, high-throughput screening, proteomics, and genomics. Now the same types of innovation can be applied to drug development to prevent valuable lead compounds from sitting idle on the shelf.
by Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
