Insights On Pharmaceutical Production

1. Sanitary Mixing In Multi-Agitator Systems 2/4/2020

   Multi-shaft mixers are versatile systems used in the production of food, beverage, pharmaceutical and medical products. This bulletin discusses a few equipment features commonly supplied on multi-shaft mixers intended for sanitary applications.

2. Tips For Viral Vector Production 8/7/2019

   The viral vector market continues to grow, and the increased interest in improvements in manufacturing technologies is driven by recent approvals in cell and gene therapies. These scalable and cost-efficient processes for GMP manufacturing environments address viral vector manufacturing challenges.

3. Preventing Cross-Contamination – Operating Beyond cGMP 7/22/2020

   Conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination. This blog shares best practices from a CDMO for preventing cross-contamination.

4. Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership 10/8/2019

   Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.

5. Multi-Agitator High-Shear Mixing System Assists In CMC Dispersions 4/15/2019

   Conventional agitators are unable to create the fluid circulation necessary to properly disperse 4%+ powdered CMC dispersions. The consequence of insufficient agitation is the formation of non-dispersed lumps.

6. Technical Considerations For Developing Oral Solids (Part 1) 8/3/2020

   Navigating your oral solids project from development through commercial manufacture can be a challenging path. In a two-part series, four oral solids experts from Pfizer CentreOne’s global network and partner organizations discuss the technical considerations to be aware of. In this first installment, we look at the importance of technical groundwork and understanding excipients in the early stages of your project.

7. Tools For Preparing For Digital Transformation 11/20/2020

   This presentation will explore tools that biopharma development organizations can use to prepare for digital transformation. We will discuss tools that help companies visualize complex processes in a simple diagram, tools for identifying waste and inefficiency in the process, and tools for visualizing the steps of complex processes.

8. Line Of Sight - Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production 7/29/2020

   Line of Sight suite of freeze-drying equipment with scalable lyophilization technologies and process analytical technology (PAT) tools have been developed to provide the tools for a more successful scale-up of a lyophilization process from formulation through to full commercial production. This ensures superior product quality and uniformity and creates a data rich environment across all sizes of freeze-drying systems.

9. Small And Emerging Biopharma Companies Outsourcing Practices 9/22/2020

   There is no question that the drug development services industry is complex, dynamic, and continuously evolving. While every sponsor company is different, all can benefit from keeping a pulse on current outsourcing practices and the activities being outsourced. Over the past year, ISR conducted several research activities with the aim of better understanding the needs of small and emerging biopharma companies and how they differ from the larger industry players. This article highlights the results of this survey.

10. Security Of Supply In Cell And Gene Therapy Manufacturing 9/24/2020

    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.