Manufacturing

Pharmaceutical Outsourcing Manufacturing

Contract development and manufacturing companies, or CDMOs, provide a wide range of drug development, formulation and manufacturing services to companies that need outsourcing help to bring pharmaceutical products to market.

Full-service contract development and manufacturing companies can take on every aspect of drug development and manufacturing – many can develop a variety of dosage forms. Specialized CDMOs typically concentrate on one kind of dosage form.

Services offered by contract manufacturing organizations typically include, but are not limited to:

  • Formulation
  • Analytical Services
  • Blending
  • Coating
  • Tableting
  • Parenteral Product R&D and Manufacturing
  • Aseptic Filling
  • Unit Dose Semi-Solids
  • Transdermal Product Development and Manufacturing
  • Topicals
  • Converting
  • Packaging
  • Serialization
  • Shipment

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  • Future Manufacturing Constraints

    Sunday, November 20, 2016
    Around 2003 was a peak crunch-time or period of concern that severe bioprocessing capacity shortages would develop, with utilization rates peaking then at 76% for mammalian systems and many potential blockbusters in the pipeline. The subsequent ... read more

  • Parenteral Preparations, Challenges in Formulations

    Sunday, November 20, 2016
    Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants.1 They are sterile preparations intended to be administrated directly into ... read more

  • HORIZON LINES: A Quarterly Review of NDAs – 2Q16

    Sunday, November 20, 2016
    This column summarizes New Drug Applications (NDAs) approved in the second quarter 2016 (May-June 2016). In this quarter, FDA approved 23 NDAs. read more

  • 2016 Wrap-Up: Looking Ahead to 2017 and Beyond

    Sunday, November 20, 2016
    As we bid farewell to 2016 to face the opportunities and challenges of 2017, the global life sciences industry can be best described as being on the cusp of great change. For the last ten years, U.S. market growth has been transitory, with M&A ... read more

  • An Interview With Shawn Cain, Chief Operating Officer, LSNE

    Sunday, November 20, 2016
    In general, how has the lyophilization market changed over the last five years? How have these changes allowed LSNE to better assist your clients? read more

  • What’s The Real Answer to Rising Costs of Blockbuster Drugs? Competition

    Sunday, November 20, 2016
    The 400 percent increase in the cost of the life-saving allergy treatment EpiPen has gotten its manufacturer, Mylan, into some deep scrutiny – and rightly so. Maybe it’s a combination of greed, market dominance, regulatory requirements and clearly ... read more

  • Handling Highly Potent Actives and Controlled Substances Safely and Securely

    Sunday, November 20, 2016
    Growth in demand for new anti-cancer drugs has seen more and more pharmaceutical companies researching highly potent molecules, but these companies may not have the specialist resources and infrastructure needed to take these developments beyond ... read more

  • Blinding and Randomization Strategies for Well-Controlled Clinical Studies

    Sunday, November 20, 2016
    Prior to the adoption of newer, more advanced systems we use in clinical trials today, bias was a common theme. As noted in the article: “FDA and Clinical Drug Trials: A Short History” by Suzanne White Junod, Ph.D., this was often observed when ... read more

  • CMO/CDMOs: Looking Ahead

    Friday, September 30, 2016
    The number one trend from last year’s edition demands a repeat (see - (http://pharma-bio.org/pdfs/CPhI%20annual%20report%202015.pdf - page 46). The CMO/CDMO sector remains fragmented, and business logic dictates that the sector needs to consolidate (... read more

  • Biopharmaceutical Manufacturing Globalization Continues

    Friday, September 30, 2016
    Around 45% of biopharmaceutical manufacturing organizations expect to off-shore at least some of their operations over the next five years, with the figure dependent on the nature of the activity, according to BioPlan Associates’ 13th Annual Report ... read more

  • HORIZON LINES A Review of NDAs for January-February, 2016

    Friday, September 30, 2016
    This column summarizes New Drug Applications (NDAs) for January-February, 2016. In these two months, FDA approved 25 NDAs. read more

  • Ensuring Data Quality in an Outsourcing Environment

    Friday, September 30, 2016
    The hurdles and costs associated with bringing a drug through the development and approval process have skyrocketed. Over the past forty years, the average cost of running a preclinical program has jumped from hundreds of millions of dollars to ... read more

  • The CMO/Sponsor Relationship: How to Strike the Perfect Balance

    Friday, September 30, 2016
    The roles of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are growing at light speed as pharma, life sciences and biotech firms of all shapes and sizes discover the benefit of outsourcing key functions in the... read more

  • Coming Clean on Quality in the Chemical Manufacturing Lab

    Thursday, July 21, 2016
    The price of ensuring quality in chemical manufacturing goes far beyond cost. Hopefully, quality problems are caught before they can affect patients but even then, such problems can make or break a manufacturing organization. In the U.S., while it... read more

  • Biopharma Vendors Offering Services Bundled With Products

    Thursday, July 21, 2016
    Vendors to the biopharmaceutical manufacturing industry are seeing an opportunity to offer valuable services that complement their products. This is increasingly a strategic priority for introducing new products, according to BioPlan Associates’ ... read more
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