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Targeting ‘right first time’ with the new In-silico Strategies Workstream

Targeting ‘right first time’ with the new In-silico Strategies Workstream

Sep 2020 | ,

In-silico modeling is an exciting, new area for many biomanufacturers as it creates the opportunity to reduce wasted experiments, lower costs and accelerate development. However, there are many challenges ahead before it is used effectively and consistently, including different methodologies being applied and the need for data quality. BioPhorum Development Group’s sponsors highlighted that in-silico modeling is an industry hot topic and so the...

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How industry is using technology during the COVID-19 pandemic

How industry is using technology during the COVID-19 pandemic

Sep 2020 | , , , , , , , , ,

The use of technology in its many forms was a recurring theme in BioPhorum’s recent COVID-19 Workforce Protection Survey that was completed by the Senior BioPhorum Connect group, which consists of the leaders and sponsors from the BioPhorum communities. The survey assessed how industry was reacting to COVID-19 to identify and share best practices that would help guide its reaction to the crisis. This article looks at the role of technology in...

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New risk-based deviation management system can save members an average of 22,200 hours per site

New risk-based deviation management system can save members an average of 22,200 hours per site

Sep 2020 | ,

Under a traditional deviation management system (DMS), all events are considered equal and usually require a 30-day closure, regardless of complexity. However, treating them the same drives poor behaviors and promotes a check-the-box mindset because users do not have to think about the real reasons for an event. This is why BioPhorum’s Deviation Management Systems (DMS) Workstream has published its Guide to implementing a risk-based deviation...

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How to assess EHS risks for commercial-scale CGT manufacture

How to assess EHS risks for commercial-scale CGT manufacture

Aug 2020 | ,

The rapidly expanding field of cell and gene therapies (CGT) has the potential to revolutionize curative treatments. However, among the many hurdles ahead are that occupational health and safety guidelines for the manufacture of CGT products have been lacking and there is no clear framework for considering risks for operators when working at a commercial scale. The result is that there is no ‘universal’ biosafety risk assessment template for...

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Best practice forecasting – a new tool to enable a dialog on demand planning

Best practice forecasting – a new tool to enable a dialog on demand planning

Aug 2020 | ,

When biomanufacturers and their suppliers discuss future demand for materials, a robust forecast is crucial to provide a structure for a transparent and open conversation between both parties. It is the simplest, least expensive risk mitigation tool they have, and forecasts are often crucial in executed supply agreements Feedback provided by the Forecast & Demand Planning Workstream indicates there are differing levels of maturity and...

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Connected data, cobots and smart scientists: how to create the lab of the future

Connected data, cobots and smart scientists: how to create the lab of the future

Jul 2020 | ,

Many will recognize that the biopharmaceutical quality control (QC) laboratories need much more digital enablement to align with the rest of the manufacturing environment. Issues range from a lack of automation and data not being captured automatically or consistently for advanced analytics. Change and industry collaboration is clearly needed – and a vision of the future has been delivered by BioPhorum through a new paper, Manifesto: Digital...

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Jul 2020 | , , , ,

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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PUPSIT: identifying risks and preventive controls

PUPSIT: identifying risks and preventive controls

Jul 2020 | ,

Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on...

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A clear path to implementing alternative and rapid microbiological methods

A clear path to implementing alternative and rapid microbiological methods

Jul 2020 | , ,

Several alternative and rapid microbiological methods (ARMM) are now available to detect and enumerate microbiological contamination. Regulatory authorities are encouraging the biopharmaceutical industry to adopt these innovative technologies – but the path is sometimes clouded. Although there are some guidance documents available, a holistic description of the entire end-to-end implementation process is still missing. This is why BioPhorum has...

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How to solve the CCI puzzle

How to solve the CCI puzzle

Jul 2020 | ,

Container–closure integrity (CCI) is a vital patient-safety and product-efficacy aspect of parenteral biopharmaceuticals. The challenge is how to identify, qualify and maintain the appropriate methods to ensure CCI’s role in providing patient and regulatory confidence in these medicines. To describe an overarching approach to CCI and BioPhorum’s work in this area, Scott Ewan has written an article called A Holistic Approach to Container–Closure...

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