DRUG DISCOVERY FEATURED ARTICLES & APPLICATIONS

  • Challenges, Risks and Strategies for Biologic Substance Manufacturing

    From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.

  • Advancing Safety and Efficacy Studies with Novel Surgical Applications

    Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery,  novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.

  • Operational Excellence: In a Flexible Manufacturing Environment

    By thinking outside of the box, CDMOs can create a flexible and scalable business model that offers a level of assurance in the face of forecast variability.

  • How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

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LATEST NEWS

  • FDA Approves Genentech’s Xolair (omalizumab) For Allergic Asthma In Children

    Genentech, a member of the Roche Group , recently announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age, who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4

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Fume Hoods Fume Hoods
The ChemGARD and ChemGARD-RI fume hoods use continuous a flow bypass design, which is
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Sigma Inhibitor Cocktails are designed for protein isolation research and offer effective protease or phosphatase inhibition...
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The Production Supplies and Services Catalog offers over 9,000 products to protect people, products, and processes in cleanrooms, controlled environments, and production areas...
Lipid Library
The Screen-Well Bioactive Lipid Library enables researchers to rapidly screen and identify ligands for orphan receptors...
Drug Process Development Drug Process Development

Althea’s complete range of drug Process Development capabilities offers the tools to address your needs. We develop processes for producing small quantities of proteins for early testing or establish robust, reliable and scalable processes that enable a strong commercial advantage. Althea also provides access to a proprietary drug delivery platform, called Crystalomics® technology, for the development of alternative drug delivery formulations of second generation drug substances.

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Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
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