Preclinical Development

Perfect your formulation and analytical test methods.

Develop a scalable formulation for your drug product and solidify your analytical test methods. Work with our team and leverage:

• Decades of experience working specifically with lipid-based solutions
• Advanced analytical testing equipment
• A smooth transition from preclinical development to process scale up, clinical batch and cGMP manufacturing.

During the entire 25+ years we have been manufacturing drug product at our Indianapolis manufacturing site, we have always focused on two core technologies: lipid-based formulations and PEGgylation. We have strategically placed ourselves as a niche pharmaceutical company, providing end-to-end service for clients that operate in this market. Because we maintain integrity to this focus, we continue to operate as industry experts.

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Preclinical Development at Exelead includes:

• Raw Materials Selection
• Formulation Development
• Analytical Method Development
• Design of Experiments
• Pilot Batches
• Manufacturing Process Optimization & Development
• Analytical / Microbial Method Suitability, Feasibility & Robustnes

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Case Studies

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Product Development of a Liposomal Antifungal Ophthalmic Formulation – Screening Studies

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Process Optimization for a Liposomal Product – A Potential Metabolic Replacement Therapy Candidate

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Formulation Optimization of a Hydrophilic Small Molecule Liposomal Product

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Process Development of an RNA Oligonucleotide-Based Lipid Nanoparticle Formulation

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