Bioprocessing White Papers

  1. Is Automation The Disruption Pharma R&D Needs?

    According to a recent report from PhRMA, U.S. biopharmaceutical companies spend more than 13 times the amount of R&D per employee than all other manufacturing industries.

  2. The Five-Point Plan To Fix Your Records Management Strategy

    Given the ever-increasing amounts of information being generated by systems, applications and measurement tools, a strategic approach to managing information is a requirement, not a luxury. Every record within your company represents a huge opportunity for organizations wishing to act with agility, so the proper management that information should be a priority.

  3. Managing The Complexities Of Pharmaceutical And Life Science Logistics

    Manufacturers and shippers of these products are under increasing pressure, as pharmaceutical and life science logistics becomes more complex and as the consideration towards better control of falsified medicines increases.

  4. Continuous Processing Optimization With Smarter Tools

    Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

  5. Crystalomics: A Pathway Forward For Protein Crystallization

    Protein crystals have shown the potential to address many of the issues associated with high concentration/high viscosity solutions. While formulation and delivery challenges exist with crystallized formulations, they are not insurmountable. With access to the right level of expertise and experience, a company can manufacture its product using crystallization, thereby increasing patient compliance by offering an easier and faster form of drug delivery. 

  6. Accelerating Biopharmaceutical Development From DNA To Drug

    The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.

  7. Closed System Filling Technology: A New Paradigm

    “Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment.

  8. 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.

  9. Virus Retentive Filtration In Biopharmaceutical Manufacturing

    Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells. Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion.

  10. Streamlining Pharm Drug Development: Yes, It’s Time.

    The path from molecule to market isn’t getting any easier. The costs of drug development over the last five years have continued to rise while sales during the same timeframe have tumbled. This calls for streamlining of today’s current drug development process. Read how today’s experts think this can be accomplished.