Outsourced Pharma App Notes & Case Studies

  1. What Is Quality By Design (QbD) – And Why Should You Care?

    Proper implementation of QbD can potentially provide three main benefits for development.

  2. Managing Risks Within Platform Processes Through Media Components
    A platform process is a set of standardized protocols and reagents that can be used to support a variety of clinical molecules. An enhancement to the platform can be spread across multiple clinical molecules, improving an organization’s return on investment. By SAFC
  3. Bioburden Entry Points In Downstream Processing

    Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.

  4. Zero Margin For Error: The New Reality For Generic Pharmaceutical Manufacturers

    Generic pharmaceutical manufacturers are facing a business dichotomy: The overall market for generic drugs is growing but at a slower pace as the number of branded drugs entering the market is shrinking, diminishing opportunities to capitalize on expiring patents. Consequently manufacturers face numerous challenges that can significantly impact operational efficiencies and revenue growth. 

    Shifting and compacting markets, disappearing branded drug queues, economic pressures, and an influx of manufacturers entering the generic market are all contributing to shrinking individual revenue streams, causing many companies to map out new avenues to grow market share. The challenges are formidable, as generic manufacturers seek new products, business models, and more efficient business practices to overcome revenue-threating risks.

  5. Unlocking The Potential For Efficiency In Downstream Bioprocesses

    In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

  6. Frozen Drug Packaging
    A biopharmaceutical company known for the development of novel therapeutic drugs had a pressing requirement to package a biohazardous frozen drug product. Having worked previously with Aptuit and having experienced excellent results, the client had the confidence to engage Aptuit’s Clinical Packaging and Logistics assistance. The project was conducted at Aptuit’s facility in Allendale, New Jersey. By Aptuit, Inc.
  7. Manufacturing Continuity Of Biopharmaceuticals In An Uncertain Environment

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

  8. 6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  9. Integrative Biology: At The Tipping Point
    I recently met Gustavo Salem, VP and general manager of the Biological Systems Division at Agilent Technologies. Salem believes integrative biology is at a tipping point for producing major breakthroughs in the drug development. By Rob Wright, Chief Editor, Life Science Leader magazine
  10. Obtaining Good Yields With High Purity Of An N-terminal Histidine-Tagged Protein

    ÄKTA start eliminates the hassles of manual protein purification handling, such as loading large sample volumes and continually monitoring UV readings, and can give you consistency of yield and purity. Madhu demonstrates how ÄKTA start aided him in purifying a recombinant N-terminal histidine-tagged protein.