Insights On Pharmaceutical Production

1. What Is Process Validation? 8/4/2021

   The goal of process validation is to confirm the process design and demonstrate that the commercial manufacturing process performs as expected.

2. Successful Control Strategies – Part 1 1/24/2022

   With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.

3. Mixing Technology Unrivalled In Dispersion Of Hormonal Active Ingredient 6/9/2021

   A pharmaceutical manufacturer contacted Silverson as they wanted to develop a production process for an intravenous oncological medicine. The medicine would consist of a low viscosity liquid into which a hormone based active ingredient (AI) needed to be dispersed. The nature of the hormone was the challenge in this application as it had to be dispersed finely enough so that the suspension remained stable and didn’t separate over time, but it could not be over-sheared otherwise the associated medical effects could not be guaranteed, leaving a small margin for mixing and dispersing the AI effectively.

4. Thermo Fisher Scientific EMEA Single-Use Technologies Capacity Expansion 3/2/2021

   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.

5. Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions 11/11/2020

   Several drug products utilizing continuous manufacturing processes have been approved by the FDA, with many others in clinical development. Review the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates.

6. Increased Productivity With Concentrated Fed-Batch 6/7/2021

   A large biopharma company wanted to establish a single-use multi-product facility by choosing appropriate upstream processes that can deliver more than 500 kg/year throughput. This case study shows how a concentrated fed-batch process was established, enabling higher productivity and increasing the throughput.

7. Something Big Is About To Take Biopharma Development Into The Digital Age 12/16/2020

   IDBS are announcing the world’s first Biopharma Lifecycle Management (BPLM) system – a cloud-based platform that smooths the bumps of biopharmaceutical development – easing the curation of the data you need to accelerate time to market.

8. Reducing Mixing Times For Pharmaceutical Creams And Ointments 12/30/2020

   Cream or ointment products can be either a water in oil (w/o) or oil in water (o/w) emulsion, consisting of waxes, emollients, and lubricants dispersed in an oil phase, and a water phase containing emulsifying, stabilizing, and thickening agents, preservatives, and, in some cases, colorant. Read how to reduce mixing times while improving product uniformity and consistency.

9. How Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

   Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

10. Mixing And Blending Of Carbopol 1/10/2021

    Challenges of Carbopol include dusting problems, the formation of agglomerates that are not readily dispersed, and poor flow properties, to name a few. The correct mixer can avoid these problems.