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Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and FiltrationCreation 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.
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Applications: A Total Water Purification SystemAlthough sounding like a singular term, a water purification system actually consists of several key components.
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Components of the Pharmaceutical Industry Are ConvergingAs the various industry sectors expand drug discovery and development activities, there will be more direct competition as well as opportunities for collaboration.
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Affinity Chormatography Removes EndotoxinsProtein 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.
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Tips on Selecting a Special-Fabrication SupplierThe bulk of a biopharmaceutical processing unit can be assembled with off-the-shelf components. However, special fabrications — especially fluid components — enable fabricators and manufacturers to meet critical construction deadlines and move projects forward with minimal or no delays.
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FDA Inspections: Is Your Organization 21 CFR Part 11 Compliant?Decoding what FDA means by ?narrow interpretation? and ?enforcement discretion? goes a long way toward helping you understand the FDA?s latest guidance on 21 CFR Part 11 and making sure your organization is compliant before an inspection.
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Chloroplasts: Transforming Biopharmaceutical ManufacturingA 20% TSP-producing cultivar can generate up to 265 pounds of crude recombinant protein per acre.
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US Regulation of Plant-made Biopharmaceuticals, Part 2In the first part of this feature (Jan. 2005) we discussed the technical background and the role that FDA, US Department of Agriculture (USDA), and Environmental Protection Agency (EPA) play in setting the rules for accepting plant-made biopharmaceuticals (PMBs). We now continue by discussing how producers will be able to take products to market.
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Upcoming Technologies to Facilitate More Efficient Biologics ManufacturingChoosing the right tools to enhance the process.
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Chloroplasts: Transforming Biopharmaceutical ManufacturingA 20% TSP-producing cultivar can generate up to 265 pounds of crude recombinant protein per acre.
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A Major Force in Biotechnology SwedenIn September 2003, Sweden's biotechnology sector recorded a striking achievement. Amgen, the world's largest biotechnology company, announced plans to acquire exclusive rights to Biovitrum's small-molecule enzyme inhibitors for the treatment of metabolic diseases.
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Career Development: Keeping Your Secrets in Your CompanyThe employer's first step in considering whether to use non-competition and non-disclosure agreements is to assess, analyze, and understand the benefits of such agreements.
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Finding a New Position in a Competitive Job MarketResearch and preparation are key to obtaining and successfully conducting an interview.
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Increasing Plant Efficiency Through CIPUnfortunately, once circuits are commissioned and validated, optimizing - or even adjusting - them is difficult and rarely done because of the time and effort required for revalidation.
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Beyond GMPs: The Latest Approaches to Good Manufacturing PracticesGMP is the acronym for Good Manufacturing Practice. The GMPs represent a set of regulations that were promulgated as a final rule by FDA in 1978 and intended to ensure the safety and efficacy of the nation's drug products. The GMPs, as we know them today, are the result of over a century of actions by industry and reactions by government and consumer groups to bring guidance and controls to the food and drug industry, resulting in a safe supply of food and medicines.
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Assessing Shelf Life Using Real-Time and Accelerated Stability TestsBiopharmaceutical products in storage change as they age, but they are considered to be stable as long as their characteristics remain within the manufacturer's specifications. The number of days that the product remains stable at the recommended storage conditions is referred to as the shelf life.
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US Regulation of Plant-made Biopharmaceuticals, Part 2In the first part of this feature (Jan. 2005) we discussed the technical background and the role that FDA, US Department of Agriculture (USDA), and Environmental Protection Agency (EPA) play in setting the rules for accepting plant-made biopharmaceuticals (PMBs). We now continue by discussing how producers will be able to take products to market.
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BMS or PLC? Controlling the Regulated EnvironmentIf the system is not 21 CFR Part 11-capable or the network configuration is not appropriate, cost is immaterial.
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Affinity Chormatography Removes EndotoxinsProtein 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.
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Let There Be Light: Plant-Made Pharmaceuticals' New Home is UndergroundThe mine space is greater than the volume of all homes for a city of one million people. The second facility has been mapped at 22,500 acres.
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Characterization of TrypZean: a Plant-Based Alternative to Bovine-Derived Trypsin (Peer-Reviewed)An in-depth characterization of maize-derived trypsin revealed an unusual nonconsensus N-linked glycosylation.
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Advocating for Biosimilar Approval Standards Under BPCIFDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
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Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
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Operational Excellence: More Data or Smarter Approach?The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
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Biosimilars Regulation in the US: The ChallengesThe pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?
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Advocating for Biosimilar Approval Standards Under BPCIFDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
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Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
