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On the plug-and-play audit trail to connect intelligent pieces of equipment

On the plug-and-play audit trail to connect intelligent pieces of equipment

An audit trail is a secure, computer-generated, time-stamped electronic record that allows the reconstruction of events around the creation, modification, or deletion of an electronic record. It should be in a clear and specific format and capture key data, including when (date and time), by whom (identity), where (location, terminal or device identification), and what (detail about the change). However, many end-users have significant issues...

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‘From grass to glass’: how BioPhorum’s Strategic Framework will influence the whole in-bound supply chain

‘From grass to glass’: how BioPhorum’s Strategic Framework will influence the whole in-bound supply chain

Covid-19 has not only highlighted the criticality of the in-bound supply chain but some of the long-standing, systemic frailties that have allowed demand to outstrip supply and limited the supply chain’s ability to support industry growth. These include the poor interaction between biomanufacturers and suppliers and bottlenecks that could impact rapid scale-ups. If we are to adjust to the new normal as we move from ‘pandemic to endemic’,...

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Supplier change notifications – bringing color to a grey area

Supplier change notifications – bringing color to a grey area

Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a...

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Release specifications for master cell banks – your chance to make a difference

Release specifications for master cell banks – your chance to make a difference

Gene therapy (GT) is a rapidly expanding field that could potentially revolutionize curative treatments and is an exciting new way to help patients. The number of GT processes is wide and varied, yet current regulations and guidance are not always detailed enough for industry needs. Industry is looking for initiatives to increase the speed of learning and, ultimately, influence regulatory agencies when creating guidance and policies around GT...

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BioPhorum launch new sustainability phorum

BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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A guide to integrating CPV reporting and APR practices

A guide to integrating CPV reporting and APR practices

Continued process verification (CPV) and annual product review (APR) practices are crucial for maintaining a state of control and identifying continuous improvement initiatives in the pharmaceutical and biological industries. Regulators also require both practices. However, while many companies have modeled their CPV reporting on the APR reporting process, the two practices are often not fully integrated, leading to inefficiencies. For example,...

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BioPhorum’s Plugfest showcases its plug-and-play momentum

BioPhorum’s Plugfest showcases its plug-and-play momentum

BioPhorum’s recent three-day Plugfest event performed a series of tests designed to help its Plug and Play Workstream build towards proof-of-concept testing and the commercial launch of plug and play capability.  Bill Lydon – author, analyst and consultant for the automation and controls industry – wrote an observer report for Automation.com about the event. He discussed BioPhorum’s plug-and-play vision, the innovative use of remote...

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How to perform aseptic process simulation for lyophilized products

How to perform aseptic process simulation for lyophilized products

Proposed 2020 revisions to EU Annex 1 around aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on the need for clear best practices for the process simulation of the lyophilization unit operation.   To address these expectations, BioPhorum has written an article called A better approach to aseptic process simulation for lyophilized products, which presents a risk-based, holistic best...

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How to overcome the hurdles of using small-scale models

How to overcome the hurdles of using small-scale models

Small-scale models (SSMs) are critical to biopharmaceutical process development, technology transfer, process characterization, and process validation. Demonstrating that an SSM represents the large-scale manufacturing system is also required by regulatory authorities.   However, while many biopharmaceutical companies are trying to implement qualified SSMs, there are many hurdles to overcome when designing, executing, and analyzing...

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