INSIGHTS ON DOWNSTREAM MANUFACTURING

• Effect Of Product Concentration On Continuous Parvovirus Retentive Filtration

  The higher concentration intermediates and longer process times of next generation processes may present unique challenges for virus filtration operations. Careful process development and system design can address these challenges and enable optimal processes. Watch the video.

• Strategies For Clarifying Harvest Feed Streams In Viral Vector Bioprocessing

  The ultimate goal of clarification is to prepare your cell culture feed stream for downstream chromatography and purification. The race for commercialization of gene therapies has provided an opportunity for exploring platform and templated processes in viral vector bioprocessing. Depth filtration and Benzonase® endonuclease digestion are considered gold standard unit operations in Adeno Associated Virus (AAV) production processes. Optimization of this midstream set of unit operations use should be considered a mandatory and often crucial step in process development. In this poster, we explore data driven strategies for clarifying harvest feed streams.

• Agile, Cost Effective Lyophilization Cycle Development

  Lyophilization can be expensive and time-consuming. Our lyophilization capabilities deliver cost-effectiveness, agility, and superb data-capture, and your lyophilization cycle development will be done by experienced, skilled research and development scientists.

• Achieving Agility When Facing Uncertainty — Scaling Aseptic Pharmaceutical Production

  This past year has taught us that agile organizations will not only survive, but prosper, when faced with unexpected challenges. Learn the requirements for a framework that assures agility when scaling aseptic drug production.

• Key Challenges When Selecting Media For Media Fill Tests

  In this 10-minute quick learning tutorial our expert guides you through the main challenges for aseptic manufacturers when selecting a medium for media fill tests or aseptic process simulations and how to overcome these challenges. You will learn why our products are exactly what you need to perform aseptic process simulations. We offer reliable granulated or ready-to-use media that are easy to implement in your existing processes.

• Selecting The Right Media For Your Aseptic Process Simulations

  In pharmaceutical manufacturing, product safety is vital. Aseptic processing simulations or media fill tests are performed to ensure that your facility produces microbiologically safe parenteral drugs. In this webinar, our media fill experts will give an overview of what to consider when selecting media for aseptic process simulations.

• Manufacturing Strategies For mRNA Vaccines And Therapeutics

  mRNA has emerged as a promising modality for a wide range of therapeutics and vaccines and could become the break-through technology of this century. This technology will not only revolutionize the field of vaccine development by allowing a rapid response to disease outbreaks, it will also help to address diseases of unmet medical need with gene therapy approaches or cancer treatments. Learn more with our white paper.

• Foot And Mouth Disease (FMD) Virus Vaccine: Filtration Strategies For Optimal Development And Purification

  This white paper illustrates our collaboration with MEVAC to optimize the filtration strategies used during both upstream and downstream processing of foot and mouth disease (FMD) virus vaccine to ensure scalable, cost effective and robust GMP compliant manufacturing

• Residual Protein A For Bioprocessing Applications

  Most therapeutic monoclonal antibodies (mAbs) are isolated from cell culture media using Protein A chromatography. During purification, Protein A can leach from the solid phase, ending up in the purified product. This can be problematic as regulatory guidelines dictate that detection and reduction of residual Protein A are necessary to obviate potential immunogenic consequences in vivo.  ProteinSimple’s Wes™ provides a powerful solution by bringing immunoassay into a capillary electrophoresis format.