1. Tips For Identifying And Correcting Data Integrity Deficiencies In Your Organization

    Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.

  2. 6 Factors Driving Global Biosimilar Market Growth

    There are a number of high-profile legal and regulatory decisions poised to shape the biosimilar market in the years to come. But there are also a few important trends developing that could give biosimilar makers the upperhand.

  3. Antibody Drug Conjugate Services (ADC)

    As your premier service provider, Althea’s ADC service offerings will simplify your supply chain by consolidating high containment conjugation, formulation, fill finish and release and stability testing at the same facility.

  4. Drug Product Manufacturing

    Althea delivers high quality sterile contract manufacturing and thorough inspection systems that are customized to your manufacturing needs. We offer a broad range of sterile dosage forms, including prefilled syringes, liquid vials, and lyophilized vials.

  5. Drug Substance Manufacturing

    Althea’s focused expertise and capabilities in current Good Manufacturing Practices (cGMP) production of microbial-based biotherapeutics make us one of the industry’s leaders in microbial fermentation. We offer a broad range of microbial-based cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Althea is a recognized leader in plasmid DNA manufacturing for vaccines and gene therapy products. Althea has demonstrated experience in developing and manufacturing nearly 300 cGMP lots of bulk drug substance and has an impeccable regulatory track record. Our comprehensive, validated equipment has been utilized to fulfill numerous drug substance projects for preclinical and clinical supply. For additional information about Althea’s drug substance manufacturing services including contract cGMP microbial fermentation and biologics manufacturing, please contact us.

  6. 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.

  7. The Use Of Dynamic Control In Periodic Counter-Current Chromatography

    The ÄKTA™ pcc 75 chromatography system can be used for purification of target proteins in continuous downstream processes using periodic counter-current chromatography (PCC). PCC enables greater utilization of the chromatography medium (resin) capacity, allowing sample loading to much higher levels compared with what is possible in traditional batch chromatography.

  8. Protein A Chromatography Resin: Amsphere™ A3 Datasheet

    Amsphere A3 is a new protein A resin designed with a surface modified base beadand alkali-resistant optimized ligand.

  9. Column Packing Protocol For Amsphere A3

    This packing protocol is for small columns (1-20 mL, ID=0.5-1 cm). Recommended packing method is by flow.

  10. Scalable Expansion Of Human Pluripotent Stem Cells

    The routine application of human pluripotent stem cells and their derivatives in regenerative medicine and innovative drug discovery will require the constant supply of high cell numbers in consistent, high quality. By Ruth Olmer, Christina Kropp, Claudia Huether-Franken, Christiane Schlottbom, and Robert Zweigerdt