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Seven practices to ensure your patching program is a success

Seven practices to ensure your patching program is a success

Manufacturing companies are increasingly investing in routine patching or patch management to improve their response to cyberattacks.  However, patching can be complex and disruptive in manufacturing and related support systems where the primary mission is safety then availability. Continuity of data monitoring must be maintained to demonstrate drug manufacturing conformance and...

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The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Considerations for a viral inactivation step, BioPhorum’s Drug Substance Closed Systems in CNC workstream addressed viral segregation of manufacturing steps relating to the purification process. In this follow-up paper, published by BioProcess International, the workstream looks more closely at viral contamination risks related to perhaps the...

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Steps to eradicate undetected contaminations in anaerobic testing

Steps to eradicate undetected contaminations in anaerobic testing

All biopharmaceutical manufacturers have a legal obligation to monitor the microorganisms that are found in their plant. Regulations require that the microbiological quality of biologic medicines – for efficacy and safety reasons – is assured through analysis and the application of quality risk management approaches.   BioPhorum’s Microbial Control workstream has recently published its peer-reviewed perspective...

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Using a matrix approach to address challenges for potency assay development for in vivo and ex vivo gene therapies.

Using a matrix approach to address challenges for potency assay development for in vivo and ex vivo gene therapies.

The gene therapy field is advancing rapidly and though there has been significant progress, there are yet relatively few commercial products approved globally reflecting the infancy of this modality. Some therapies have suffered setbacks due to adverse side effects in patients and limited knowledge about product quality.   With more than 400 gene therapies currently under development, it is more important than ever to improve our...

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RNA: new CGT workstream to focus on this industry priority

RNA: new CGT workstream to focus on this industry priority

When planning the 2021 BioPhorum Cell & Gene Therapy program, senior member representatives indicated that they wanted a new workstream focusing on what they considered to be the most critical topic: RNA.  By early February 2021, companies were recruited to a pathfinder activity to determine what should be covered in the workstream: RNA - mRNA therapeutics and RNA tool. Discussions led to the creation of a charter, which has been...

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Assessing EHS risks in CGT: a real-world example

Assessing EHS risks in CGT: a real-world example

In 2020, the Cell and Gene Therapy Phorum published an article Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing*.  This identified best practices and improved risk controls to consider when setting up a commercial-scale cell and gene therapy manufacturing line – from an EHS perspective.  The paper has a companion risk assessment template that is freely available on...

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Illuminating the challenges of validating cell and gene therapies

Illuminating the challenges of validating cell and gene therapies

The validation processes for general biologics and small molecule drugs are well established and there are many guidelines from regulatory agencies to provide information and advice. However, much of this information is unsuitable for cell and gene therapies (CGT) and does not consider their unique characteristics.   This is why BioPhorum has published Cell and gene therapy validation challenges. In addition to highlighting the...

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Meeting the challenges in serialization to win in the battle against counterfeiting

Meeting the challenges in serialization to win in the battle against counterfeiting

The World Health Organization (WHO) estimates that medicine counterfeiting causes one million deaths a year and that 10% of all drugs sold globally are fake. Events such as Covid-19 increase these risks by disrupting the supply chain and increasing internet purchases.  A key weapon in the battle against counterfeiting is track and trace (T&T), which is the ability to track and trace products through a supply chain – with ‘track’...

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How to create a toolbox to assess your high-risk HCPs

How to create a toolbox to assess your high-risk HCPs

Host cell proteins (HCPs) are process-related impurities derived from host cells that may co-purify with a biopharmaceutical drug product.   The detection, quantitation, and removal of HCPs from the final biotherapeutic process can be complex and some HCPs can be considered high-risk. They include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or...

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