Discovery Research Articles
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Meet The Scientist — Irina Prudnikova
Analytical research and development (R&D) works in close collaboration with formulation and process R&D to support the overall development process. Irina’s team is often the catalyst for transforming a development candidate into a viable drug formulation that improves patients' lives.
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Leveraging Novel Analytical Approaches For Advanced Therapies
Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.
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Designed For Inhalation: Pulmonary And Nasal Delivery
Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.
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Analytical Labs Particle Analysis
Particulate in a drug product represents a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. As concern about particulate rises, partnering with a particle analysis team enables customers to gain an intimate understanding of particle sources related to packaging and delivery systems.
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Developability Assessment
The developability evaluation comprises in silico analysis as well as a series of in vitro assays for the drug candidates, so to provide information about the integrity, purity, aggregation, thermostability, charge heterogeneity, glycosylation, poly-reactivity, potency, stability over low pH and accelerated storage conditions, and potential PKPD profile.
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cGMP Cell Therapy Manufacturing Capabilities
The cell and gene therapy market is experiencing accelerated market approval opportunities, record breaking investments, robust therapeutic pipelines, and positive clinical outcomes – all driving the need for speed, regulatory know-how, and innovation in manufacturing technologies.
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Scientific Insights Lab Simplifying The Journey From Molecule To Market
Drug development programs should aid customers in the successful mitigation of technical and regulatory risks to ensure drug products move swiftly through the regulatory approval process and into commercialization. Get service and support to help pharmaceutical and biopharmaceutical manufacturers Simplify the Journey™ from molecule to market.
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Meet The Scientist — Sundeep Sethia, Ph.D.
Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.
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Preclinical Toxicology Considerations For Cell And Gene Therapy
Cell and gene therapeutics have inherently complex biological behaviors. Finding an experienced partner is crucial for demonstrating a novel therapeutic's safety and efficacy to establish the optimal dosing range.
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Streamlining Primary Container And Device Selection With Predictive Calculations
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.