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  1. Process Development and Scale-Up of Ceramic Hydroxyapatite Application Guide
    9/29/2016

    This is a guide for the use of CHT as a media support in your purification process.

  2. Process Development And Scale-Up Of Ceramic Hydroxyapatite
    9/29/2016

    CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.

  3. Stain Free Gels Confirm Protein Purity Brochure
    9/29/2016

    A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.

  4. Stain Free Gels Confirm Protein Purity
    9/29/2016

    A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.

  5. Biomanufacturers: How To Reduce The Complexity Of Custom Single-Use Assemblies
    9/28/2016

    Based on a discussion with Guy Matthews, market development manager with Parker dominick hunter.

  6. Modeling Time-Dependent Processes More Accurately To Improve Quality And Control
    9/28/2016

    Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.

  7. Best Practices For Measuring System Quality For Drug-Device Combination Products
    9/28/2016

    Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.

  8. Integrating Safety And Immunogenicity Assessments Into The Biopharma Preclinical Development Process
    9/27/2016

    Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.

  9. Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
    9/26/2016

    With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.

  10. Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century
    9/22/2016

    This article will be part of the CPhI 2016 Annual Report, which will be released during the CPhI Worldwide event in Barcelona (October 4-6, 2016).