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| Drug Delivery Trends for Parenteral Therapeutics
| There is a growing need for patient-compliant dosage forms within the cancer therapeutics and biotechnology areas. Ease of administration, enhanced therapeutic efficacy, and reduced side effects are factors that differentiate drug delivery products from conventional dosage forms and provide a competitive advantage. This article reviews salient trends in the parenteral drug delivery sector within the realms of a changing regulatory environment, drivers to growth, and recent advances in this field. Challenges associated with bringing parenteral drug delivery concepts to commercialization are discussed.
 | | | Eisai Breaks Ground for Parenteral Drug Facility
| | Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs. | | | Developing First Disposable Injector for a Biopharmaceutical
| | Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases. | | | Applications of Poly(ethylene in Drug
| | Poly(ethylene oxide) is gaining the attention of research and development organizations and its application is extending into a wide range of drug delivery systems. | | | Bioseparations Look Ahead to the Past
| | Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.) | | | Genentech Anticipates Full-Capacity Manufacturing
| | Genentech Anticipates Full-Capacity Manufacturing | | | A New Concept in Aseptic Filling: Closed-Vial Technology
| | A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity. | | | Minimizing Risk Through Technology
| | New technologies and improvements to existing ones can reduce contamination risk in aseptic processing. | | | Aseptic Production, Gowning Systems, and Airborne Contaminants
| | Study results show that the state of a cleanroom clothing systemnew or much usedinfluences the protection efficacy of the system. | |  MORE ARTICLES
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| ExcipientFest Attendees Discuss Regulatory and Quality Concerns
| | San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition. | | | Qualification, Validation, and Verification
| | This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use. | | | Acceptable Analytical Practices for Justification of Specifications
| | The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic. | | | Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements
| | The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article. | | | The Impact of Impurity Analysis on Future Regulations
| | As technology for impurity analysis improves, scientists are gaining better information and asking for more regulatory guidance. | | | The Harmonization of the Microbial Limits Tests
| | The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for implementation in 2009. This article describes the harmonized USP Chapters <61> "Microbial Enumeration," <62> "Absence of Specified Microorganisms," and <1111> "Microbiological Attributes of Nonsterile Pharmaceutical Products," and suggests they will likely require some revalidation of existing methodologies. Companies should put plans in place immediately for this work and show consistent progress towards this goal. | | | Adventures in Chromatography
| | We really knew what we were doing—until we opened the column for a routine repacking. | | | Vial Defects Detected in Roche's Herceptin in Europe
| | London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials. | | | Perrigo Recalls 11 Million Bottles of Acetaminophen
| | Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall. | | | MORE ARTICLES
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