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  • The Drug Candidate Journey

    A Smoother Journey

    The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet tempting with reward.

    Knowing what to expect, where to go for support, and uncovering biotech startup resources can smooth the path for emerging biotechnology and biopharmaceutical companies.

    Click the arrow on the right or use the buttons above to begin your journey from Discovery to Manufacturing, from funding to protecting intellectual property and complying with regulations.

  • The Drug Candidate Journey: Discovery

    A biologics candidate journey of 1,000 miles…

    Funding will be necessary to validate your therapeutic compound candidate, as you take the protein-based molecule through target validation, lead identification, and optimization.

    You will also need intellectual property (IP) protection. Researching and filing for patent protection – and understanding best practices to increase chances for success – is critical at this early stage.

    More >
  • The Drug Candidate Journey: Pre-Clinical Testing

    Safe & Effective

    Pre-clinical testing establishes that the target compound is safe and effective – before it can be tested in humans. The in vitro, in vivo and animal testing at this stage can take several years – as many as six.

    The goal here is preparing and filing an Investigational New Drug (IND) application.

    To cover toxicology and safety studies, prepare for manufacturing considerations, and outline clinical trials protocols, you need capital.

    It is also helpful to begin understanding the regulatory requirements – so you’re staying the course and correctly tracking data you’ll need later when filing the IND.

    Download Integrated Bioprocessing Brochure

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  • The Drug Candidate Journey: Phase I

    It's Only Human

    Phase I means you’ve filed your IND and are ready to begin evaluating your drug in humans.

    More funding – in the millions – will be necessary to survive the average three-year span of Phase I clinical trials. These test the drug in a group of 20-80 healthy individuals to determine:

    • That the drug is safe
    • How well it metabolizes
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  • The Drug Candidate Journey: Phase II

    Is it Effective?

    Phase II tests the effectiveness of the biomolecule in actual patients with the disease or illness you’re attempting to treat. These years-long (three, on average) clinical trials involve a few hundred volunteers and help determine the drug’s safety, any side effects, and optimal dosing.

    Phase II is high stakes, because determining efficacy is critical to obtaining the funding you need to continue testing. Learn more about funding requirements and how to obtain capital here.

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  • The Drug Candidate Journey: Phase III

    Statistically Proven

    Phase III trials use a much larger patient population – in the thousands – to give statistical weight to results that can prove safety and efficacy. This phase helps determine the drug’s benefit-risk ratio. Averaging three years, Phase III trials consume the vast majority of overall investment – as much as 90 percent – because of the requirement for validation, larger size, and greater risk.

    We offer technology transfer and facility design services to prepare you for transitioning from clinical to commercial production.

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  • The Drug Candidate Journey: Manufacturing

    The Finished Product

    Whether manufacturing clinical trial batches or commercial production, your manufacturing process must meet the same high standards as your R&D and clinical trials.

    Things to consider in the manufacturing phase:

    • Regulatory compliance
    • Engineering optimization
    • Single use manufacturing
    • Your own 12K to 20K bioreactor or a CMO?

    Download Integrated Bioprocessing Brochure

    More >

Biotech Resource Hub: Stay Current

Advance Biotech Grant Program – Accelerating Therapeutic Development in Life Science

The Life Science business of MilliporeSigma is expanding its commitment to the global biotech community with its Advance Biotech Grant Program. Through the newly expanded grant program, every six months, three recipients around the globe will be awarded a total of €200,000 in free services and products to address their process development challenges. In total, six companies will benefit from the Advance Biotech Grant Program each year. Press Release

Find out more about our programs:

Bringing your molecule to market. As part of our commitment to meet the needs of the life science community, we’ve developed several programs that recognize stand-out emerging biotech companies. These programs are designed to support biotech start-ups and medium sized companies in solving their current bioprocess development challenges to bring the next generation of molecules to market.

More details about EB Programs>

WEBINAR: Accelerated ADC Development with Integrated Supply Chain Solutions

Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.

Watch Now >

WEBINAR: RNA Based Therapeutics and Vaccines: Bioprocessing Technology Trends

Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.

Watch this Webinar >

WEBINAR: Managing Process Scale-up and Tech Transfer

Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.

Watch this Webinar >

Webinars On-Demand >

WHITE PAPER: 2017 Life Science Executive Summit

Establishing an open dialog within the biotech community....

Read more and download >

The Changing Biopharma Risk Equation

A report from the The Economist Intelligence Unit sponsored by MilliporeSigma.
This paper, which incorporates the results of a survey of 254 pharmaceutical executives from around the world and a range of interviews with industry experts, explores in detail global pharmaceutical companies' growth strategies and their plans for managing the associated risks.

Read the study >

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Research. Development. Production.

We are a leading supplier to the global Life Science industry: solutions and services for research, development and production of biotechnology and pharmaceutical drug therapies.

© 2017 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
EMD Millipore is a part of Merck KGaA, Darmstadt, Germany.