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Orderly Documentation Management During StartupOne of the critical early tasks of the documentation team is coordinating plans and requirements with the start-up team.
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Producing Affordable, High-Purity WaterA water distribution plan is at the heart of an overall energy and water conservation program.
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Technology Transfer: A Contract Manufacturer's PerspectiveThe objective of the feasibility stage is to determine whether the proposed biotechnological process can be executed.
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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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An Overview of the Biopharmaceutical Applications of Chitosan and AlginateChitosan and alginate hydrogels are high-molecular-weight carbohydrate polymers used in an extensive array of pharmaceutical applications. While many applications depend upon the ionized state of the polymer, other factors play an important role in the pharmacological activity of complexes that include these agents.
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Strategies for Extending the Life of PatentsPharmaceutical companies today are faced with increased costs for drug discovery and development and aggressive competition from generic drug companies. As research costs skyrocket, generic drug companies sit poised and ready to compete as soon as a patent expires.
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Producing Affordable, High-Purity WaterA water distribution plan is at the heart of an overall energy and water conservation program.
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A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 3: Effects of Manufacturing Changes in Immunogenicity and the Utility of Animal Immunogenicity StudiesManufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.
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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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INTEGRATING BMS and PCS Systems in the GxP EnvironmentIn most production environments, it is critical to be able to associate historical environmental data with process data.
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Disposables: Biopharmaceutical Disposables as a Disruptive Future TechnologyToday, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale.
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Microarray Applications in Drug Discovery and DevelopmentPatient stratification could accelerate drug expansion into new indications through faster, smaller, more definitive Phase IV trials.
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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.
