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Do you want to influence the future of long-range planning?

Do you want to influence the future of long-range planning?

Biomanufacturers are in a unique and difficult position as they need highly specific critical raw materials, in comparatively small quantities, for life-saving therapies. However, there is no industry consensus on a strategic view of how the supply chain and demand will evolve in the next five years or more. This poses a significant risk to patients and healthcare providers, e.g., through drug shortages and price increases. Suppliers and...

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A media fingerprinting toolbox that comes with a host of benefits

A media fingerprinting toolbox that comes with a host of benefits

Cell culture media raw materials can contain many chemical substances, each with its own properties. While simple substances can be identified using classical methods (such as Fourier-transform infrared spectroscopy), it is more challenging when dealing with complex mixtures as they can be composed of multiple compounds even if they are chemically defined. Media manufacturers have mature quality control and manufacturing procedures in place and...

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How to bridge the data integration gap between sponsors and contract organizations

How to bridge the data integration gap between sponsors and contract organizations

Biopharmaceutical supply chains and manufacturing networks have become increasingly complex, often involving multi-enterprise collaborations and partnerships to supply lifesaving medicines to patients. Initial projects to improve digital collaboration often deployed bespoke point-to-point solutions between sponsor and contract organizations. However, without standardization, data, and data structures differ between sources, vary over time, and...

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Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice of a globally interconnected supply chain, cutting off cities and international supply hubs, and straining raw material supplies and stocks. These global events continue to put pressure on an inbound supply chain model that has its roots in ‘just-in-time’ lean manufacturing practices. A range of measures will...

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Everything you need to know about ‘ready to use’ cells … on a poster

Everything you need to know about ‘ready to use’ cells … on a poster

Biologics potency is an important component of an overall CMC analytical control strategy, which is widely determined by cell-based bioassays. However, developing robust and reliable bioassays places increased requirements on the analytical cells with low inter-assay variability (e.g., cell passage number, harvest) to deliver high-quality potency data. ‘Ready to use’ cells (RtU) offer many benefits, including reduced assay variability, and...

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How the bioprocess industry has weathered the COVID-19 storm

How the bioprocess industry has weathered the COVID-19 storm

The COVID-19 pandemic has created unprecedented stress on supply chains in nearly every global manufacturing segment. Bioprocessing and healthcare have been hit especially hard as suppliers struggle to find materials to meet the demand for COVID vaccines and therapeutics. On top of ongoing non-COVID biologics projects being manufactured, this has created serious supply chain stress. The bioprocessing industry has been instrumental in addressing...

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BioPhorum’s Deliverables Report 2022 – all our content at your fingertips

BioPhorum’s Deliverables Report 2022 – all our content at your fingertips

BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months. Throughout the year, our members from across the biomanufacturing, biotech, and medtech industries identify challenges, discuss solutions and produce the guidance, roadmaps, and position...

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An ECA, BioPhorum, and APIC Joint Conference

An ECA, BioPhorum, and APIC Joint Conference

Raw materials, excipients, and APIs used for biological medicinal products 22 - 23 Nov, Dusseldorf, Germany BioPhorum is delighted to partner on this joint conference. Janmeet Anant, Merck will present "Industry proposal for the use of QbD and ICH Q12 tools and principles to enable second sourcing of critical materials​", Amandine Calvet, Boeringer Ingelheim presents "BioPhorum approach to media...

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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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