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Life Sciences

Formulation Development

Innovative Nucleic Acid Therapeutic Formulation Leverage our team’s support to empower your project with expertise across a wide range of nucleic acid modalities, state-of-the-art facilities, and a successful history working through novel challenges. We are experienced in the formulation of nucleic acid-based therapeutics as high concentration liquids, lipid nanoparticles (LNPs), novel nanoparticles, and packaged within […]

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Analytical Development

Analytical Method Development & Testing Have confidence in your molecule’s safety and efficacy by partnering with our analytical development and testing team. We have experience with nucleic acid therapeutics ranging from small nucleotide drugs and highly-modified oligonucleotides (e.g., ASO, siRNA, PMO/PPMO, PNA) to larger RNA and DNA molecules needed for gene editing and gene therapies.

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Bioanalytical Services

Comprehensive Bioanalytical Services Before you can proceed with dosing and administration activities, prepare to make informed decisions with reliable bioanalytical data detailing your prospective compound’s safety and efficacy. Our highly experienced team performs GLP- and GCLP-compliant bioanalytical method development, validation, and testing of samples from (non)human tissues. By conducting this bioanalysis, the resulting insights support

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Characterization

Experienced Nucleic Acid Therapeutic Characterization Gain insights about your nucleic-acid derived therapeutic’s safety, efficacy, and developability with stage-appropriate analytical and biophysical characterization. Our team’s experience ranges from small nucleic drugs and highly modified oligonucleotides (e.g., ASO, siRNA, PMO/PPMO, PNA) to larger RNA and DNA molecules needed for gene editing and gene therapies. Reliable analytical characterization

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Clinical Supplies Manufacturing

Proven Clinical Manufacturing Success of Biopharmaceuticals Overcome complexity and variability in biologics manufacturing by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your available material and bringing your compound to market faster while meeting current quality, health, and safety standards. Leverage our extensive GMP clinical supplies manufacturing capabilities,

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Process Development

Prepare Your Drug Product with Process Development Prepare your product for advancing into the clinic and beyond with our integrated approach to the drug development process. We help you develop downstream purification processes, repurification, UF/DF, compounding, and challenging formulation processes. Our approach focuses on gaining a deep molecular understanding of the API while maintaining a

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Formulation Development

Optimizing Biologic Formulation Development Accelerate your biological product with our comprehensive formulation development support. Partner with us for a faster, easier, and more effective drug development process. Our Design of Experiment (DOE) approach integrates everything you need for efficiency and success, including Assessing samples under accelerated stress conditions Selecting stable drug formulations with sufficient solubility

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Analytical Development

Comprehensive Analytical Testing & Development Advance your biotherapeutic entities by partnering with our team to develop stage appropriate analytical methods. We secure your downstream testing success with our precise Quality by Design (QbD) approach, in-depth understanding of macromolecule physicochemical properties, and state of the art analytical instrumentation and columns.After establishing method feasibility, our team optimizes

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Analytical Characterization

Complete Materials Characterization of Your Biopharmaceutical Any changes to your biotherapeutic drug development process, from the expression system to manufacturing process, impacts your product’s chemical stability, conformational stability, and resulting activities. It is important to characterize your biologic to de-risk downstream development. Utilizing state-of-the-art equipment, our experienced scientists use stage-appropriate analytical, biophysical, and compendial testing

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Clinical Supplies Manufacturing

Customized & Reliable Clinical Supply Manufacturing Advance your program with reliable, compliant clinical supplies by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your drug substance materials and bringing your compound to market faster while meeting all current quality, health, and safety standards. Leverage our extensive GMP clinical

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