OUTSOURCED PHARMA EDITORIAL

Boxes At BMS: Impact Of New Drugs On Packaging Sponsors And Providers

Packaging is transparent to the end-user when done well, but open to criticism from all quarters when done poorly. We can, though, expect an increasing amount of attention all the time. “There are more diverse packaging needs than ever before,” says Dan Marasco, head of Packaging Materials & Device Sourcing at Bristol-Myers Squibb.

More Editorial...

OUTSOURCED PHARMA GUEST CONTRIBUTORS

  • Revisiting Manufacturing Facility Design: A CFO Takeaway
    Revisiting Manufacturing Facility Design: A CFO Takeaway

    Manufacturing facilities in the pharma industry may set a high bar for complexity and capital density as compared with the wider industrial community. Therefore, you might expect that the process of design for these complicated facilities would be a top priority from the earliest stages of a project. 

  • Big Data Analytics: The Next Evolution In Drug Development
    Big Data Analytics: The Next Evolution In Drug Development

    The drug development process is complex and financially risky. A recent study by The Tufts Center for the Study of Drug Development estimates the cost of developing a new drug at $2.6 billion and suggests that costs of drug development are rising with a compound annual growth rate of 8.5 percent.

  • The Unsung Powers Of Moderation In Business
    The Unsung Powers Of Moderation In Business

    We live in a society that worships the new, the radical and the fast; yet we live on a planet that overwhelmingly favors a moderate pace to win the race. Can both be right?

  • The Crowd Will See You Now: How Do-It-Yourself Healthcare Will Make The World A Better Place…Someday
    The Crowd Will See You Now: How Do-It-Yourself Healthcare Will Make The World A Better Place…Someday

    We live in an era of convenience. We can, if we choose, grab dinner without leaving our cars, watch from the sofa as the the lawn service trims our hedges, wait for UPS to drop off our new clothes, and hang our dry cleaning outside the door for pick up. We live a life our grandparents only dreamed of. 

More...

OUTSOURCED PHARMA INSIGHTS

  • What Is The Difference Between Method Verification And Method Validation?
    What Is The Difference Between Method Verification And Method Validation?

    Clients have come to us in the past asking "We need 'method validation'.” Sometimes they'll use the term “validation” or “verification” but it seems apparent they're not really clear on what the difference is between the two. For the most part it’s not that well-known that method validation is a much more rigorous process. What’s really needed, more likely, is the establishment of a verification regime that assures analytical methods perform reliably, accurately, and precisely for its intended application.

  • Managing QbD From A CMO Perspective
    Managing QbD From A CMO Perspective

    The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

  • How Sustainability Efforts Change Your Supply Chain For The Better
    How Sustainability Efforts Change Your Supply Chain For The Better

    Going green is moving from a clichéd corporate phrase to simply the way business is run. Companies around the globe continue to make significant investments in sustainability that benefit not only the environment, but also the customers they serve. What does green mean for specialty logistics — and why does it matter for your supply chain? World Courier explores a few of the most critical questions shippers are asking when it comes to eco-friendly innovation.

  • Good Manufacturing Practice: The DNA of Pharmaceutical Quality
    Good Manufacturing Practice: The DNA of Pharmaceutical Quality

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. 

  • Fundamentals Of Spray-Dried Dispersion Technology
    Fundamentals Of Spray-Dried Dispersion Technology

    A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.

  • CMO Selection: Going From "Could Fit" To "Good Fit"
    CMO Selection: Going From "Could Fit" To "Good Fit"

    Where does one start? For most drug owners seeking contract manufacturing support, it all depends on the type of product that they have. There’s always a set of established criteria, but there are a few other things for partner-seeking companies to look at, but it really depends on the mix and the philosophy of the organization, their cost sensitivity, price sensitivity, how aggressive they want to be, etc.

  • Finding A Contract Manufacturing Partner That Fits
    Finding A Contract Manufacturing Partner That Fits

    Any journey of discovery begins with the first step and so it goes when seeking manufacturing and contract services partners. The likely goal of course is to find partners that “fit,” but getting to whatever constitutes a “good” fit relative to your organization is a process that one should start with a bit of introspection; sort of like “you can’t have a good relationship with someone else until you know who you really are first.”

  • How To Develop A Successful Regulatory Strategy

    A regulatory strategy can be defined as a science-driven assessment of a program from the earliest stages of development, which is put in place to accomplish a number of key clinical and regulatory goals. As technologies become more complicated, medicines more specialized, and regulations more stringent, the risks associated with not having a regulatory strategy in place have become more numerous and significant. Today, implementing a regulatory strategy can easily mean the difference between a drug becoming a commercial success or a clinical failure.

  • Seahorse Bioscience Keeps Product Development Information In Sync With Omnify Empower
    Seahorse Bioscience Keeps Product Development Information In Sync With Omnify Empower

    Seahorse Bioscience provides analytical instruments, biomanufacturing systems, and consumable labware products for biological research and drug discovery. Seahorse technology is used to advance understanding of the role of cell metabolism in neurodegeneration, aging, cancer, cardiovascular, cell physiology, toxicology and hepatobiology, immunology, infectious diseases, mitochondrial diseases, model organisms, obesity, diabetes, metabolic disorders, screening, and translational medicine.

  • What Is The Best Way To Keep Up With Changes In FDA Standards?
    What Is The Best Way To Keep Up With Changes In FDA Standards?

    This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

More...

OUTSOURCED PHARMA FEATURED SUPPLIERS

  • Pfanstiehl, Inc.
    Pfanstiehl, Inc.

    Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

  • Metabolon
    Metabolon

    Metabolon, Inc. has advanced the field of metabolomics by pioneering and patenting the industry’s leading biochemical biomarker discovery and profiling platform. It has developed the technology to quickly identify and measure all of the biochemicals in a biological sample through its proprietary global processing method.

  • AMRI
    AMRI

    With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.

  • Patheon Inc.
    Patheon Inc.

    Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.

  • WellSpring Pharma Services
    WellSpring Pharma Services

    WellSpring provides peace of mind to pharmaceutical companies for their contract manufacturing and packaging needs. When you work with WellSpring, you'll have a whole team of professionals backing your project. Our team will oversee the entire operation; while a project manager will help you plan all stages. You'll also have a dedicated technical team to manage all aspects of the project. All this at one convenient location, offering everything from clinical to commercial manufacturing, packaging and analytical testing services for virtually all non-sterile dosage form products including, tablets, capsules, creams, lotions, ointments, gels and oral liquids.

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles
Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

OUTSOURCING EVENTS

Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers

September 2, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!

Using Social Media for Patient Recruitment in Clinical Trials

September 3, 2015
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions

September 9, 2015
1pm-2:30pm EDT, Online Training

Laboratory Data Integrity: Current Expectations for OOS Result Investigations

September 16, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!

The World Courier Biomedical Seminar

September 17 - 18, 2015
Cologne, Germany
More Events...