December 5th 2024
Many factors must be considered to overcome the challenges associated with viral clearance.
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Testing a New Chromatography Column for Cleaning Effectiveness
January 1st 2006Cleaning validation is a critical consideration in the pharmaceutical industry. Inadequate cleaning can result in contamination of drug products with bacteria, endotoxins, active pharmaceuticals from previous batch runs, and cleaning solution residues. Such contaminants must be reduced to safe levels, both for regulatory approval and to ensure patient safety.
By the Numbers: What it Costs to Operate a Biopharmaceutical Facility
October 1st 2005Operating costs are the white-hot issue in the boardrooms of our life sciences clients and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.
THE FEASIBILITY OF TANGENTIAL FLOW FILTRATION FOR CELL LYSATE CLARIFICATION
September 21st 2005Is it realistic to believe that tangential flow filtration (TFF), commonly used for concentration, desalting, buffer exchange, and protein fractionation, is now a viable alternative to centrifugation for cell harvest and cell lysate clarification? A new generation of membranes expands the possibilities for TFF as an economical, efficient, high-yielding process substitute, according to this case study?s author.
Comparative Filterability Trials ? The Utilization of Appropriate, Effective Filtration Areas
September 15th 2005Filterability trials are essential to the successful evaluation of total throughput of single filters or filter combinations. As such, they must be comparable. This case study examines the differences among various devices used and suggests necessary action required to achieve comparability of filterability test trials with 47 mm disc composites.
Efficiency Measurements for Chromatography Columns
August 1st 2005Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.
Disposables Solve Tomorrow's Manufacturing Problems
July 1st 2005Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.
Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration
April 1st 2005Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes - chromatography and filtration.
Developing the Future: Big Questions, Multiple Answers
April 1st 2005When 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.
Final Word: Disposable Systems Meet Today's Manufacturing Needs
February 1st 2005Disposable 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.
Pleated Membrane Filters Improve Process Economics
January 1st 2005The 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.
Affinity Chormatography Removes Endotoxins
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.
Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFP
November 1st 2004Human 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.
High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge
February 15th 2002By 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.
Considerations During Development of a Protein A-Based Antibody Purification Process
January 15th 2001by 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.