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How to avoid the ‘valley of death’ when adopting new technology

How to avoid the ‘valley of death’ when adopting new technology

The biopharmaceutical industry plays an increasingly pivotal role in providing treatment options for widespread and rare diseases, but a lack of innovation and technology are factors that keep the costs of new medicines high. There are also multiple barriers to implementing new technologies, including their pathway to adoption. To help clear the pathway, BioPhorum has developed a New Technology Adoption Portal to support any adoption program....

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Helping the ICH refine its guidance on analytical procedures 

Helping the ICH refine its guidance on analytical procedures 

The ICH plans to develop a new Quality Guideline, ICH Q14 Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, to potentially combine both documents into one for simplification and clarity. The ICH has asked for industry comments as part of the documents’ public consultation, and BioPhorum member views have been gathered and published in BioPhorum feedback on ICH Q14 and Q2(R2).....

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Now you can have a simple, compliant, and valuable equipment revalidation strategy

Now you can have a simple, compliant, and valuable equipment revalidation strategy

The pharmaceutical and biotech industries are asked to deliver medicines at faster speeds and lower costs – while continually improving compliance to ensure the safety and efficacy of finished products. Adapting to this model involves reviewing historical practices and implementing more efficient ways of working. Validating equipment and facilities is typically done when facilities are built, or new equipment is purchased and installed....

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Are you on the right road to unlock the value of digital technologies?

Are you on the right road to unlock the value of digital technologies?

Digital Technology Roadmap Part 1: Problem Statement “The output of the Digital Technology Roadmap will provide the wider industry with a clear path forward, defining the additional technical and regulatory development focus needed for successful implementation.” Gareth Alford, Innovation & Manufacturing Technology Lead at GSK, and a key thought leader for the BioPhorum Digital Technology Roadmap team. Can’t see the wood for the trees?Most...

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How agile and sustainable is your supply chain? What is your approach to data transparency? How can you improve the efficiency and cost of the supply chain?

How agile and sustainable is your supply chain? What is your approach to data transparency? How can you improve the efficiency and cost of the supply chain?

The pharmaceutical outbound supply chain faces these and many more tough questions every day. Whilst delivering new modalities, it must meet capacity constraints, increasing costs, and greater complexity more challenging than ever before. Overcoming these challenges will need an innovative solution that pulls on business acumen and experience from across industry – and this is why BioPhorum has launched the Supply Chain to Patient Phorum. The...

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BioPhorum’s strategic framework shines a light on raw material management

BioPhorum’s strategic framework shines a light on raw material management

Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can produce life-saving medicines for patients. However, raw material variability is not fully understood between suppliers and manufacturers, which impacts yield and process continuity. There is also a poor understanding of raw material attributes, so the regulatory approach is not optimized, making changes difficult. Addressing these issues is a huge...

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Quality, safety, and cost benefits with BioPhorum’s supply change notification template

Quality, safety, and cost benefits with BioPhorum’s supply change notification template

Supply change notifications across the biomanufacturing industry have increased significantly since the start of the pandemic due to the increased requirements for raw materials used in the vaccine manufacturing process. One BioPhorum member has reported an increase from two notifications a week to 200 a month. Unfortunately, this surge has highlighted inefficiencies in the change management process for single-use systems (SUS) and its ability...

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Enabling adoption – collaboration delivers fully tested proof of concept design and dataset for NIIMBL-BioPhorum Buffer Stock Blending System

Enabling adoption – collaboration delivers fully tested proof of concept design and dataset for NIIMBL-BioPhorum Buffer Stock Blending System

BioPhorum is pleased to share for the first time the full design and dataset from a Proof-of-Concept which has performed beyond expectations, marking a step change in the biomanufacturing industry’s approach to buffer stock preparation. The publication of the Addendum to the White Paper (2019) alongside a technical article accepted by the PDA, Evaluation of the design, development, and performance of a simplified modular, mass-flow based,...

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A best practice approach for lyophilizer leak rate testing

A best practice approach for lyophilizer leak rate testing

The vacuum integrity of freeze dryers is critical for process control and maintaining confidence in sterility assurance – it is therefore key for manufacturing sterile pharmaceutical products. Although discussions on this topic have been widely published, there is no universally recognized standard, empirical standard, or scientific rationale on which to base acceptable limits on leak rates. Historically, the calculations were based on a single...

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Adopting BFPC systems: how BioPhorum is increasing the pace of change

Adopting BFPC systems: how BioPhorum is increasing the pace of change

Bio-fluorescent particle counter (BFPC) technology has been used in the pharmaceutical industry for more than a decade and even earlier in bioterrorism detection. However, despite encouragement and guidance from regulators on implementing process analytical technologies and rapid microbiological methods (that can provide early warning information through real-time monitoring), the transition to modern technologies like BFPC systems has been...

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