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The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

Driving the harmonization of regulatory requirements – one country at a time  Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes.  The potential...

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Sample sizing approaches

Sample sizing approaches

How do you justify your sample sizes for container closure integrity testing?  Most leading biopharmaceutical companies do not routinely perform container closure integrity testing (CCIT) for each batch of a commercial product, but rely on a holistic approach to ensure the consistent integrity of the finished product.  However, when sampling is required, scientifically valid approaches should be used, with plans based on risk...

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Electronic Product Information

Electronic Product Information

Why we all stand to gain from harmonized electronic product information  Electronic product information (ePI) is gaining increasing interest from many national and regional regulators, and there is a genuine desire to develop ePI solutions that add value to patients and healthcare providers.  For example, EU legislators and regulators have published their views of the benefits of ePI to disseminate information and complement paper...

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Successful outsourcing offers solutions to increased demand across the biopharmaceutical industry

Successful outsourcing offers solutions to increased demand across the biopharmaceutical industry

As demand increases across the biopharmaceutical industry, the need for streamlined approaches increases in turn. This has been particularly evident during the pandemic. To overcome challenges associated with this change in demand, companies have increasingly sought to outsource chemistry, manufacturing, and controls (CMC) development services. In doing so, companies have realized that building these successful collaborations can deliver many...

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BioPhorum embarks on collaboration platform refresh

BioPhorum embarks on collaboration platform refresh

Over the last year, BioPhorum has worked to replace a range of IT platforms to make it easier for our members to collaborate. In the past few months, we have replaced a number of systems and introduced Microsoft Dynamics.  The team is now turning attention to the replacement of iMeet Central (IMC) with a SharePoint-powered collaboration platform named the BioPhorum Hub. We will reach out to members for feedback and aim to have...

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Why applying environmental monitoring best practices will reap benefits for all

Why applying environmental monitoring best practices will reap benefits for all

Environmental monitoring (EM) programs are an effective tool in assessing the state of control in classified manufacturing areas. They are a vital part of the quality system in all modern drug production facilities and are scrutinized by regulatory agencies. However, designing an EM program is a relatively complex task; facilities vary considerably, there is inadequate specific guidance on how to design one and no single standard risk...

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How to save time and money using lyophilization modeling

How to save time and money using lyophilization modeling

An iterative design of experiments (DOE) approach has traditionally been used to perform lyophilization cycle development at small and manufacturing scales. Unfortunately, this is resource-intensive and needs large amounts of material that can make it prohibitively expensive, particularly on a commercial scale. This often prevents the use of screening experiments required to identify the optimal cycle parameters with large volumes. An...

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How to simplify the registration and regulatory lifecycle management of models

How to simplify the registration and regulatory lifecycle management of models

Models have been used in the manufacture of pharmaceutical and biological products for many years, especially for small molecules drug products. Yet, the benefit of being able to predict a product or process attribute or a manufacturing parameter without having to measure them has been increasingly offset by the regulatory burden of updating those models during their lifecycle. As large molecule teams have started to use models for development,...

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Fostering a step change in automated equipment interfaces

Fostering a step change in automated equipment interfaces

Equipment skids usually need to be treated as bespoke units when they are connected to control systems, which places automation on the critical path for facility design, build and reconfiguration. Any problems can clearly have major implications for a facility project – builds and reconfigurations would be much easier and quicker if equipment interfaces were standardized and offered interoperability. BioPhorum’s new Stirred tank unit: interface...

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How the collaboration model is accelerating the biopharmaceutical industry

How the collaboration model is accelerating the biopharmaceutical industry

BioPhorum’s mission is to create an environment where the global biopharmaceutical industry can collaborate in order to accelerate their rate of progress for the benefit of all. To support this mission, Dan Spacie, CEO will present on the importance of collaboration at the BioProcess International COVID-19 Therapeutic Development & Production meeting being held from 27-28 April. The presentation forms part of a program delivered...

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