INSIGHTS ON DOWNSTREAM MANUFACTURING

• Sterilizing Grade Filtration Unit Operations For Plasmid DNA Processes

  The large size of pDNA can present a challenge for sterile filtration unit operations within your gene therapy manufacturing since the product can be retained by the filters, leading to both yield loss and low filtration capacity. Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!

• Chromatographic Purification Of Plasmid DNA

  Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).

• Optimize Scale-Up And Increase Capacity For Vaccine And Therapeutic Manufacturing

  In order to accelerate development and manufacturing in the era of SARS-CoV-2, companies are designing scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. Read this article to consider a new way of doing business by reviewing existing capabilities, assessing risk tolerance, and identifying key resources to accomplish your goals.

• A Shot In The Arm For mRNA Vaccines

  Standard methods of preparing mRNA require multiple purification steps, sometimes-costly single- use resins, and various chemicals. At the commercial scale, such methodology is impractical; at the vaccine scale (hundreds of millions of doses per annum), it is impossible.

• How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine?

  As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.

• Characterization Of A Low Molecular Weight Product-Related Impurity In A Manufactured Fc-Fusion Protein

  Fragment crystallizable (Fc)-fusion proteins are a growing class of biopharmaceuticals that have gained popularity due to the manufacturability benefits and extended drug half-life afforded by the Fc fragment. This case study focuses on one such fusion protein, consisting of a protein receptor fused to a human IgG Fc fragment.

• The Faster Path To Self-Administration- Moving From Pre-Filled Syringe To Auto-Injector

  Ypsomed and Catalent Biologics share how to transition your product from pre-filled syringe to auto-injector more quickly with an experienced partner who can anticipate equipment and process needs in this on-demand webinar.

• Improved Design Reduces Contamination Risks In Final Filtration And Filling Processes

  This presentation focuses on final filtration and filling in single use assemblies. We discuss new product and system designs that help customers meet regulatory expectations and reduce contamination risk while maximizing product recovery.

• Efficient Purification Of A Recombinant Protein From Escherichia Coli Fermentate

  The purification and manufacture of recombinant proteins, especially those lacking affinity handles, often requires multiple chromatography steps and complicated feedstream conditioning, resulting in high production costs and relatively low recovery. The objective of this study was to purify one such recombinant protein, EPA, from E. coli fermentate to >95% purity and recovery.