INSIGHTS ON PHARMACEUTICAL PRODUCTION

• 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.

• Thermo Fisher Scientific EMEA Single-Use Technologies Capacity Expansion

  Thermo Fisher Scientific is expanding our single-use manufacturing network globally. Our Cramlington, UK site has expanded clean room space and invested in chamber manufacturing equipment for our BioProcess Containers and fluid transfer assemblies. Quality systems and processes have also been harmonized with other single-use manufacturing sites to provide true manufacturing redundancy for our customers.

• Security Of Supply In Cell And Gene Therapy Manufacturing

  With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

• Cultivation Of Sf9 Insect Cells And rSEAP Expression

  This application note describes the cultivation of Sf9 suspension cells in the Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5.0 L.

• Mixing And Blending Recommendations For Sterile Ingredients

  Products manufactured under sterile or cleanroom conditions - for example injectables and vaccines - present different challenges, especially regarding product sterilization. For these products, mixing would normally take place before sterilization but there are instances where post-production sterilization is impossible for technical reasons, placing further restrictions on the mixing process.

• Fast And Effective Digital Transformation

  We identify common challenges when deploying traditional customized solutions, contrast that with the benefits of an out-of-the-box approach, and cover the critical role of change management. 

• Mixing And Blending Strategies For Emulsified Vaccines

  To produce a stable W/O emulsified vaccine with maintained immunity-inducing properties, the manufacturing process must achieve small emulsion droplets (<1 µm) with a monomodal and narrow particle size distribution. The use of high shear energy provided by a rotor/stator mixer is required to reach this target.

• Why A Modular Continuous Pilot Plant Might Be Your Flow Chemistry Solution

  There are still very few companies that have been able to successfully scale-up an API or intermediate with one or more continuous chemical process steps beyond the kilogram range under cGMP conditions. The best option to overcome the limitations in capital costs and timelines is known as a Modular Continuous Pilot (MCP) plant.

• A New Way Of Looking At De-Nesting And Re-Nesting Solutions

  The emphasis for designing and manufacturing systems to handle drug container is on container integrity and gentle handling to prevent breakages and product losses. We have developed the innovative, automatic handling unit Nestor to process ready-to-use containers, such as syringes, to and from nests and tubs.