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Most contract manufacturing organizations (CMOs) offer routine CMC analytical support for batch release and other QC testing requirements, but few can offer the breadth of analytical techniques and expertise required to navigate today's challenging drug development landscape.
At ABC, we are analytical experts. When you partner with us, you add experienced analytical chemists to your team who truly understand your compound's chemistry, structure and behavior. Not only do you get timely delivery of stability and other QC data, you can be assured of robust, validated methods to support seamless transfers and reduce supply chain risk, expert unknown identification capabilities, analytical expertise to manage unexpected issues and professional guidance to proactively address anticipated regulatory concerns.
Why Analytical Expertise Matters
ABC has developed thousands of analytical methods ranging from titrations and stability-indicating assays to residual solvents and the most complex trace-level impurities found in leachables. We have experience with a wide range of APIs and drug product formulations, various types of compounds (small molecules, peptides, proteins, cytotoxic and potent compounds) and every route of administration in an array of product delivery systems: solid orals, liquid orals, thin films, transdermals, parenterals, stents, osmotic pumps, metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulized products and more.
Our state-of-the-art facilities have the capacity to meet scale-up and development requirements from small, specialized projects to NDA stability programs. ABC offers more than 150,000 square feet of laboratories, plus 35,000 cubic feet of DEA-secured stability storage space covering all ICH, photostability and customized conditions.
Our laboratories are very well equipped to support a wide array of analytical techniques including Soxhlet and microwave extractions as well as preparative HPLC; a variety of separation technologies (HPLC, UPLC, GC and IC) and detection methodologies including LC/MS, GC/MS LC-MS/MS, TOF/MS, photodiode array (PDA), corona aerosol detector (CAD) and conductivity detection.
ABC's dedicated Trace Analysis and Structural Chemistry (TASC) team offers more than 100 years of combined experience employing advanced ID and quantification techniques, interpreting mass spectroscopy and nuclear magnetic resonance spectroscopy, and applying broad-based polymer knowledge to deliver industry-leading extractable & leachable programs, with unique expertise in parenteral, inhalation and other container/closure systems.
Our subject matter experts stay abreast of regulatory changes like the FDA's official guidance on how to best conduct and document method transfers, and the USP's recent proposal for a general chapter <1224>. Our analytical experts will work closely with you to provide the most suitable methods for your needs, so your CMO can focus on what they do best.
For precision in CMC support, choose an analytical expert. Choose ABC. |
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