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Applying Continuous Improvement (CI) ManufacturingContinuous Improvement requires a sound philosophy. Is your company following the correct principles?
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Development of a Novel Platform TFF System for Insect Cell Culture HarvestThe overall average flux rate for the concentration and diafiltration step was 41 L m–2 h–1.
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Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
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The Laboratory Control System: Fulfilling cGMP RequirementsReserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
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Best Practices in Demand and Inventory PlanningThe foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.
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Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
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The Value of a Supplier AllianceThese latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations
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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: Collaborate to Compete?Daunting but common challenges currently face many biotech, pharmaceutical, and device firms. These companies are encountering a restless public, worried investors, and a skeptical, publicity-hungry Congress that are all concerned about product safety and the reliability of regulators' scrutiny.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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Assuring the Effective Use of Standard Operating Procedures (SOPs) In Today's WorkforceSOPs are written job aids that detail the procedure of how to do a specific job task correctly.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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A Systems-Based Team Approach to GMP ComplianceCompanies faced with real or threatened FDA sanctions are usually least prepared to react effectively.
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GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological ReagentDevelopment guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.
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Closing Gaps in Quality Control of Electronic DataAll potential uses and supporting endeavors of the data must be examined and then defined as a virtual process stream.
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Final Word: The Economic Impact of the Supreme Court Decision in Merck v. IntegraOn June 13, 2005, in Merck KgaA v. Integra Lifesciences I, Ltd., the US Supreme Court ruled unanimously that the exemption to patent infringement outlined in Title 35, Section 271(e)(1) of the US Code extends to all uses of patented inventions reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act, including preclinical studies. In practice, this means that the exemption will allow companies to use other firms' patented compounds for experimentation on drugs that are not ultimately the subject of a submission to the Food and Drug Administration.
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Risk-Based Cleaning Validation in Biopharmaceutical API ManufacturingValidation of a cleaning process demonstrates that it can reliably and effectively remove residue to an acceptable level.
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Production of Recombinant Therapeutic Proteins in the Milk of Transgenic AnimalsCapital investments in production plants represent a significant portion of the cost of new recombinant drugs
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Form Fluidly Follows FunctionIn the fast-changing pharmaceutical industry, adaptable planning provides a competitive edge.
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Protecting Patents for Personalized MedicineThere are several challenges associated with protecting patents for personalized medicines.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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Knowledge Management Strategies for Biologics Research$200 million and two years could be shaved off a drug's development time by using informatics effectively.
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Chromatographic Purification of MAbs with Non-Affinity SupportsAn anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.
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Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
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Conducting the Audit - Ready or Not, Here They ComeWhen an FDA inspection is imminent, it pays to have a plan. Start by getting your paper in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don?t forget to take notes.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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Next Generation Peptide Mapping with Ultra Performance Liquid ChromatographyUltra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.
