Biosimilar Development insights

  1. Cross Flow Filtration Method Handbook

    This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.

  2. Optimizing the Flexural Strength of Bioprocess Film

    This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.

  3. CDMO Horror Stories And How To Avoid Them

    Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.

  4. The Extreme Costs Of A Bioburden Incident - Infographic

    Apart from the potentially tragic impact on patients, the economic consequences of a batch failure are enormous. For the mAb blockbusters, a month production stop can result in lost revenues of up to 1 billion dollars and a typical QA investigation could cost $20,000.  Thankfully, there are solutions for decreasing the risks.  Download this Infographic on the financial impact of a bioburden incident and ways to reduce said impact.

  5. Insights And Tips When Addressing Bioburden Challenges

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

  6. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

    White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.

  7. The Next Generation Of Bioprocess Engineering: Bringing A Perspective From The Last Two Decades

    The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering.  Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective.   What should we expect to see from industry and academia to keep the field moving forward?

  8. Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency

    Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach.  Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.

  9. Batch And Fed Batch Culture — Practical Steps For Better Results

    Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria  and their interactions with each other can be a key differentiator in the race to get your drug to market. 

  10. Fermentation And Cell Culture: Bringing The Basics To The Fore

    Fermentation and cell culture can be carried out in batch or continuous processes.  Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.