Compounding Practices and Their Impact on Product Quality

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By Margaret Speed Ricci and Hanns-Christian Mahler

Margaret RicciHanns-Christian MahlerProtein biopharmaceuticals are frequently prepared aseptically in a hospital pharmacy or manufactured in advance in a compounding facility or center, and the ready-to-administer preparations are likely subjected to a holding time before use. Aseptic preparation (or “traditional” compounding) of ready-to-administer parenteral preparations by dilution, reconstitution, or infusion preparation can be done for individual patients within a hospital pharmacy, whereas bulk production (or “nontraditional” compounding) of ready-to-administer preparations at compounding centers is considered manufacturing. Because of the scale of production and potentially significant holding times of the compounded products, general good practice (GxP) manufacturing considerations should be required. Continue reading

Certificate of Analysis (CoA) and Release Testing for Biologics—What Analytical Assays Are Needed?

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By Eliza Fung, Jonathan Haulenbeek, and Jamie Moore

Eliza Fung-finalJonathan Haulenbeek-finalJamie Moore-finalIn recent years, the development of biologics is the fastest growing segment of the pharmaceutical industry. Biologics are quite complex and heterogeneous compared to small molecules. As such, appropriate testing is required to be developed to monitor the quality attributes of the biological products during the drug development life-cycle, which supports chemistry, manufacturing, and controls activities including release and stability testing for drug substance and drug product. Quality attributes include those that define the identity, strength, potency, and purity of the biological product as indicated on the Certificate of Analysis (COA). Continue reading

Careers in Pharmaceutical Drug Development: Academic and Industrial Outlook and the Role of AAPS

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By Urvi Gala and Rakesh Gollen

Urvi Gala-finalRakesh GollenThe pharmaceutical profession in general can easily be considered as a stable, virtuous, and lucrative vocation. In fact, for ages it has been regarded as “recession-proof.” Today, with ever-advancing lifespans, the number of associated diseases has also increased, thus creating a surge in demand for not only novel therapeutics but, more importantly, better therapeutics. A Nature article predicts an increase in pharmaceutical funding by 2020 due to the growth seen in public and private sector partnerships. Continue reading

Topical Delivery of Nucleic Acid and Protein Therapeutics: Unmet Needs and Potential Applications

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By Cedar H. A. Boakye and Roger L. Kaspar

Cedar BoakyeRoger KasperRecently, there has been an upsurge of interest in enhancing topical delivery of large biomolecules into the skin for the management of diverse dermatological disease conditions. The stratum corneum, which forms the outermost layer of the skin, prevents body water loss through the skin and is a formidable barrier to entry of foreign substances, particularly those that are charged and have a molecular mass of greater than 500. Continue reading

AAPS Pharmaceutical Science Roundup, October 2014

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breastcancerawarenessroundupIn recognition of National Breast Cancer Awareness Month, the October edition of the roundup features articles on breast cancer treatments, prevention, testing, and impact.

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