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Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) AreasThe complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
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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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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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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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Final Word: Suppliers Can Help Companies Achieve Speed to MarketIn today's competitive and fast-paced environment, owner companies must get products to market quickly and efficiently. By redefining how they provide services and products, suppliers can enhance their value and help owner companies reap the greatest financial returns.
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Discovering Value in Outsourcing Facilities ManagementYour company's job is to make biopharmaceutical products. Managing facilities is a function supporting the main task. General manufacturing companies discovered this long ago, but pharmaceutical producers have been lagging. Once you consider the outsouring of non-core activities like facility management (FM), office services, space planning, and utilities management, you can focus on core business functions that make profits.
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Final Word: Plant-Made PharmaceuticalsThere is no current capacity crunch due to increased investments in new facilities.
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Technology — The Third "Arms Race" in BiomanufacturingSpeed of response, small-scale manufacturing and process flexibility will become increasingly important.
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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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Managing Quality While OutsourcingAs with any partnership, working with a CMO can be complex. The level of trust and cooperation between both organizations needs to be extremely high.
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Five Tips for Better Biotechnology WritingYour company can improve its productivity by improving the writing skills of its technical people. Poor writing skills may not show up on a balance sheet, but they can be a big problem. A one-month delay in getting FDA approval - due to ambiguous writing - can cost a company millions of dollars.
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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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Information Age AuditsUnderstanding the reach of 21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.
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Biosafety Considerations for Cell-Based TherapiesIs it safe? Answering that question for therapies based on living cells is not simple.
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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.
Latest:
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.
