The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued.. see attached
The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued… see attached
https://kenx.org/wp-content/uploads/2023/04/stationery-and-cup-of-coffee-on-wooden-table-2021-08-31-17-21-03-utc-scaled.jpg15052560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-28 18:36:172023-05-05 15:38:31Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has continued to progress research… see attached
https://kenx.org/wp-content/uploads/2023/04/woman-sitting-at-desk-using-laptop-with-blank-scre-2022-12-16-07-23-31-utc-scaled.jpg17072560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-28 18:28:282023-05-05 15:37:13Paper 2: Improving Risk Based Decision Making Effectiveness: A Case For Risk Decision Review Points (KDRPS) In The Quality Risk Management Process
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches… see attached
https://kenx.org/wp-content/uploads/2020/07/webinar-6-scaled.jpg18282560Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2023-04-28 16:44:042023-05-23 19:16:43Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
https://kenx.org/wp-content/uploads/2022/05/Insight-Chart.png371808Evan HThttps://kenx.org/wp-content/uploads/2020/07/Insights-Logo22-1.pngEvan HT2022-05-19 18:59:402022-08-31 22:06:55Innovative considerations for efficient multi-(product) use of Protein-A columns
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution…
Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.
As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a sense of excitement or dread depending on their confidence in the site’s operational readiness…
Paper 4: Improving Risk Based Decision Making Effectiveness: Addressing Uncertainty
Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality
Paper 2: Improving Risk Based Decision Making Effectiveness: A Case For Risk Decision Review Points (KDRPS) In The Quality Risk Management Process
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has continued to progress research… see attached
Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
Cleaning Validation Program Design: Risk-Based Lifecycle Approach
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
CIP Cleaning Cycle Development Pitfalls and Solutions
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
Innovative considerations for efficient multi-(product) use of Protein-A columns
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…
Medical Product Excursions from Labeled Storage Conditions
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution…
Cleaning Validation Equipment Grouping
Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.
Role-based Talent Planning for Operational Readiness
As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a sense of excitement or dread depending on their confidence in the site’s operational readiness…