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Biosimilars are manufactured with different cell lines and processes than their comparator products, so it's no surprise when they look a little different. Variations such as primary amino acid sequence, glycosylation chemical modifications and protein folding issues are common. Your challenge is to determine whether those differences have clinical significance—and when they do, to make well informed mid-course adjustments to keep development moving forward.
Choosing the Right Analytical Partner May Be the Most Economically Important Decision You Make
Recent FDA guidance calls for a "complete and thorough" CMC section that begins with extensive comparative characterization of the biosimilar and reference products. This information is used to substantiate chemical, physical and bioactive similarity, which ultimately will influence the scope and number of animal and clinical studies that will be required to demonstrate interchangability. In other words, a deficit in analytical characterization expertise can equate to a great deal of lost time and money.
ABC's veteran biopharmaceutical team boasts some of the industry's foremost protein chemists, chromatographers and bioassay experts. Having helped commercialize dozens of novel protein and oligonucleotide biopharmaceuticals, they have a unique aptitude for inferring root causes of post-translational modifications; identifying those most likely to impact toxicity, pharmacodynamics and immunogenicity; and designing studies that address anticipated safety, purity, stability and potency concerns.
ABC Laboratories is Committed to Biopharmaceutical Development
Analysis of a biosimilar product requires the same diverse, high-end technology as any other biopharmaceutical. ABC has made the right investments, both in scientific talent and in the instrumentation needed to support your program. Our laboratories are equipped with the full array of chromatography, spectroscopy, electrophoresis and mass spectrometry, as well as traditional SpectraMax and cutting-edge Electrochemiluminescence (ECL) capabilities for ELISA work. And through our unique relationship with the Charles W. Gehrke Proteomics Center at University of Missouri—Columbia, ABC offers access to some of the world's most advanced analytical technology, including Bruker Avance Ultra Stabilized 800 MHz NMR, Agilent 6520 nanoflow CHIP QTOF MS, Thermo LTQ Orbitrap XL MS with ETD, T100 BIaCore SPR and many other high-level instrument platforms.
The ABC Difference: Where Science and Business Meet
The ABC Difference is about more than superior science. It's the way we manage our business—which in turn, is how we manage your programs. That begins with employing some of the industry's best and brightest development and technical experts. So you get the right expertise—whether you need help with overall strategy, study design, or simply robust analytical methods and professional project management. Our daily activities are guided by well-defined processes to promote coordination of effort, effective communication and excellent service. And we continually self-evaluate, measure our performance and work to improve all that we do. Perhaps the most important thing that sets ABC apart from other CROs is harder to quantify. It is a culture of caring, a genuine commitment. The 425-plus men and women of ABC Laboratories come to work each day making it our business to ensure our clients' success. Our purpose is to support you in your goal to develop safe, effective therapies that will help heal the world.
When it comes to biosimilar development, ABC Laboratories has no equivalent.
For more information, call: (877) 441-3325 |
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