FROM THE EDITOR

Samsung BioLogics: How To Build A CMO Business

In this exclusive interview with Outsourced Pharma, Tae Han Kim, PhD, president and CEO of Samsung BioLogics, shares his story of how he selected the biologics contract-manufacturing industry, the building of his business, and his first customers.

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OUTSOURCING INSIGHTS

  • 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.

  • How To Strengthen Risk Management Practices In The Pharmaceuticals Supply Chain
    How To Strengthen Risk Management Practices In The Pharmaceuticals Supply Chain

    The end customers — i.e. the patients — are largely uninterested in the complexities of the pharmaceutical supply chain, and if something goes wrong in the supply chain the responsibility and consequences are inevitably borne by the pharmaceutical manufacturer listed on the product pack. Management of these risks in order to ensure supply continuity is a significant challenge. Here are a few key best practices:

  • 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.”

  • Regulatory Information Management (RIM): Getting Ahead Of Change
    Regulatory Information Management (RIM): Getting Ahead Of Change

    Let’s paint a painful, yet all too familiar, scenario: After the launch of your organization’s product, new safety data necessitates a safety profile change that sets off a chain reaction affecting product composition, artwork, packaging, and labeling.

  • Are There Business Benefits To Serialization Beyond Compliance?
    Are There Business Benefits To Serialization Beyond Compliance?

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence, 

  • 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.

More Insights

OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • How To Strengthen Risk Management Practices In The Pharmaceuticals Supply Chain

    The end customers — i.e. the patients — are largely uninterested in the complexities of the pharmaceutical supply chain, and if something goes wrong in the supply chain the responsibility and consequences are inevitably borne by the pharmaceutical manufacturer listed on the product pack. Management of these risks in order to ensure supply continuity is a significant challenge. Here are a few key best practices:

  • Regulatory Information Management (RIM): Getting Ahead Of Change

    Let’s paint a painful, yet all too familiar, scenario: After the launch of your organization’s product, new safety data necessitates a safety profile change that sets off a chain reaction affecting product composition, artwork, packaging, and labeling.

  • Are There Business Benefits To Serialization Beyond Compliance?

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence, 

  • Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)

    Everyone is looking for the silver bullet: the product that will change the face of biopharmaceuticals and draw blockbuster revenues. If you have one of these, you can stop reading. But if you are like most companies, your portfolio is a mix of some winners, some underachievers, and a lot of “in-betweeners.” The process of getting the right assets on the bus (and funded) in a cash-strapped environment is as much an art as a science. As consultants to the industry for many years, we’ve seen myriad processes – both good and bad. 

  • The Scarcity Mindset: How Capacity Shortages Are Hurting The Entire CMO Industry

    It takes ninety thousand trips to the flower fields to produce eight pounds of honey. Young worker bees eat that honey and excrete from it just one pound of precious wax. Then they congregate around their tiny clumps of wax in total darkness, without oversight, using body heat to warm and manipulate the wax into delicate honeycomb masterpieces. The result is nothing short of perfection: they build to a standard that is consistently within a two percent tolerance; far better than the ten percent tolerance the walls that surround you were built to.

More From Contributing Editors...

FEATURED SUPPLIERS

  • 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.

  • 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.

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

  • Ash Stevens
    Ash Stevens

    Ash Stevens Inc. is a full-service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule drugs. Our business model is predicated on providing Sponsor clients with the safest and highest quality work product possible while meeting delivery obligations on time and on budget.

  • 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.

  • 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.

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Reprocessing Medical Devices: Final Guidance – How To Meet New Validation Requirements

July 7, 2015
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FDA Guidance on Social Media: Questions Answered and Unanswered

July 9, 2015
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Critical Site Readiness Steps for the Pre Study Assessment Visit: How to Turn Study Consideration to Study Award

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Lyophilization - An Introduction to the Scientific Principles

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