Manufacturing

Collects articles relevant to all aspects of OSD manufacturing--from producing Active Pharmaceutical Ingedients (APIs) to packaging. Includes manufacturing aspects of both tableting and capsule filling. Highlights Good Manufacturing Practices (GMP) and explores different approaching to solving OSD manufacturing issues.

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  • Computed Tomography: Applications for Evaluating Tablets and Capsules

    January 14, 2016
    In pharmaceutical applications, CT can help fast-track new product and process development and assess the characteristics of existing products. Tablets and capsules, for example, can be CT-scanned using area detectors and micro-focus x-ray tubes to ... read more

  • Good Advice: The Value of Outside Expertise

    March 16, 2017
    While high-profile CROs, CMOs, and CDMOs consolidate and grow, a cadre of individual consultants soldier on. Tablets & Capsules spoke with several of them about their work. read more

  • BAT Signal

    March 16, 2017
    When I began organizing CDMOs into a nonprofit trade association three years ago, I didn’t expect that my short-form response to, “What do you do for a living?” would be, “I’m a lobbyist for the pharmaceutical industry.” Sure, I enjoy the gasps that ... read more

  • Product Identification: The Evolution of On-Dose Product Identification

    October 12, 2017
    Imagine a world where all tablets and capsules are imprinted, allowing every tablet and capsule in a prescription to be digitally verified as they’re dispensed to patients. With a smartphone, patients anywhere in the world could instantly and at any ... read more

  • What Does a Validation Expert Do and Why Do I Need One?

    October 12, 2017
    As you’d expect, a validation expert’s work includes preparing and executing a range of protocols, such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), analytical method validation (AMV), cleaning ... read more

  • Granulation: Scaling up Wet High-Shear Mixer Granulation

    January 11, 2018
    Wet high-shear mixer granulation is a particle size enlargement process in which fine powder is combined with a liquid binder. As the binder is sprayed into the process bowl, the granulator’s impeller and chopper blades shear the powder. The ... read more

  • Outsourcing: Choosing a Contract Manufacturing Organization

    March 08, 2018
    A continuing debate for established, emerging, and about brand protection. While outsourcing can minimize your capital and labor costs, it can be challenging to evaluate CMOs and determine which one will best serve your needs as a manufacturing ... read more

  • Market Trends: Trends in the Solid Oral Drug Delivery Market

    March 08, 2018
    In recent years, parenterally delivered biologics have increasingly penetrated the pharmaceutical market due to their growing use in regenerative and personalized medicine as well as the development of new biologics and biosimilars. Despite this ... read more

  • Formulation: Developing Fixed-Dose Combinations

    March 08, 2018
    Developing new drug products is very expensive, especially when formulating new chemical entities (NCEs). Many pharmaceutical companies are turning to FDCs as a way to reduce those development costs. An FDC is a drug product that combines two or more... read more

  • Eye on Excipients: Trends in the Indian Pharma Market

    March 08, 2018
    Large pharmaceutical companies currently source less than 10 percent of the excipients they use from India and prefer to engage with suppliers located in developed pharmaceutical markets. However, the Indian excipients market is growing at 10 to 12 ... read more

  • Outsourcing: Choosing a Contract Manufacturing Organization

    March 08, 2018
    A continuing debate for established, emerging, and virtual biopharmaceutical companies is whether or not to outsource production to a CMO. At its core, the issue is about brand protection. While outsourcing can minimize your capital and labor costs, ... read more

  • Formulation: Creating Spray-Dried Dispersions to Improve API Solubility

    March 08, 2018
    API molecules intended for oral administration are often categorized using the Biopharmaceutical Classification System (BCS), which indicates the primary factors affecting API bioavailability and, subsequently, directs the formulation strategy ... read more

  • Market Trends: Trends in the Solid Oral Drug Delivery Market

    March 08, 2018
    In recent years, parenterally delivered biologics have increasingly penetrated the pharmaceutical market due to their growing use in regenerative and personalized medicine as well as the development of new biologics and biosimilars. Despite this ... read more

  • Formulation: Developing Fixed-Dose Combinations

    March 08, 2018
    Developing new drug products is very expensive, especially when formulating new chemical entities (NCEs). Many pharmaceutical companies are turning to FDCs as a way to reduce those development costs. An FDC is a drug product that combines two or more... read more

  • How to Select a Contract Packaging Partner

    March 08, 2018
    Better supply chain management has enabled some pharmaceutical companies to cut costs by 25 to 50 percent. Outsourcing packaging to a contract packaging organization (CPO), for example, transfers noncore packaging activities to a specialist and ... read more

  • From Serialization to Aggregation: A Holistic Approach

    May 10, 2018
    Counterfeit drug products and their potentially fatal outcomes are in the news nearly every week. The market for counterfeit versions of drug products such as potency l pills and heparin is booming and can have higher profit margins than the cocaine ... read more

  • Packaging: Serialization Ready?

    May 10, 2018
    The US Drug Supply Chain Security Act (DSCSA) officially went into effect last November, and the European Union’s Falsified Medicines Directive (FMD) goes into effect in February 2019. While these regulations will help to ensure the integrity of drug... read more
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