Seqens Group Expands CDMO Offerings to Include CRDO
Meet with Seqens team members at CPHi, April 25-27, 2023 to learn how we have extended services to rapidly and sustainably advance drug development. VISIT CPHI Booth 441
New! Seqens adds CRDO (Contract Research and Development Organization) services, specializing in pre-clinical through phase 2A clinical trials, to complement our CDMO services.
Focused on drug substance small molecule development, Seqens’ CRDO services offer state-of-the-art capabilities in Paris, France, and additional capacity at our Boston’Lab R&D Center, capable of taking sponsors from the discovery phase of product development to the scale-0p of New Chemical Entities.
CRDO services include extensive support in the following areas:
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Toxicology: in vitro toxicology screening (genotoxicity, hepatotoxicity, cardiotoxicity, and embryotoxicity).
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Pre-formulation: analytical profiling, solid-state screening, and physiochemical characterization; solubility and DCS (developability classification system) assessment; membrane permeation; solutions for bioavailability enhancement; and drug excipient interaction.
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Analytics: analytical methods development and validation; impurity reference standards synthesis and qualification; analytical impurity profiling (GTI); nitrosamines; extractables and leachables studies; cleaning validation; GMP release testing (raw materials, in-process and drug substances); and stability studies.
Highly Potent Active Pharmaceutical Ingredients (HPAPIs)
Shifting needs are driving a stronger demand to manufacture Highly Potent Active Pharmaceutical Ingredients (HPAPIs), and Seqens has invested $29M supported by the French government to extend its OEB4 production capacities in France
Lipids and Polymers
Seqens is strongly committed to the potential of new cutting-edge technologies for lipids, especially in the U.S. We have more than 10 years of experience in developing cationic/ionizable lipids for RNA encapsulation and in developing and batch delivering – taking clients from preclinical to commercialization.
Small Molecule Drug Substance development and manufacturing projects
Seqens continually invests to upgrade our network of R&D assets (including our new flagship early phase Boston-area facility) and manufacturing capabilities (including a newly inaugurated flow chemistry pilot unit in Paris suitable for GMP production).
Seqens stands out for a uniquely strong commitment to CSR, producing outstanding results in key environmental and social indicators.
About Seqens Group
Seqens Group is a worldwide leader in the development and production of active ingredients, pharmaceutical intermediates, and specialty ingredients. It operates 24 manufacturing sites and 10 R&D centers with 3,400 employees located on three continents. As an integrated manufacturer and supplier across the value chain, Seqens offers a broad portfolio of active ingredients, pharmaceutical intermediates, and specialty ingredients and chemicals, develops and industrializes the most demanding molecules, and is continuously innovating to develop and implement the best available technologies.
LinkedIn: Seqens
Twitter: Seqens Group
Media contact:
Linda Pendergast-Savage
Birnbach Communications for Seqens
508-224-7905
[email protected]
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