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Quality and regulatory alignment of the BioPhorum technical workstreams

LONG READQuality and regulatory alignment of the BioPhorum technical workstreamsBioPhorum has made significant progress over the last year and it continues to deliver benefits to its members. For example, there is a new Sustainability Phorum, an increasingly diverse webinar program, and the workstreams have delivered more than 100+ technical publications. Yet, there is always more to do.L1 members have requested that BioPhorum becomes the ‘one...

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Supplier and raw material improvements using BioPhorum’s maturity assessment toolkit

Supplier and raw material improvements using BioPhorum’s maturity assessment toolkit

Supplier relationships and raw materials are two of the most critical elements of biopharmaceutical manufacturing and affect everything from trust and dialogue to lead times and inventory management. BioPhorum’s maturity assessment toolkit helps members identify improvements and solutions for supply chain issues and, ultimately, support the creation of excellence in commercial biological drug supply chains.

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Reflections on Covid-19 inbound supply chain issues

Reflections on Covid-19 inbound supply chain issues

LONG READReflections on Covid-19 inbound supply chain issuesCovid-19 has had a significant impact throughout the biopharmaceutical industry, not least on the inbound supply chain, which has been hit by issues such as restricted supplies, the need for new sourcing strategies and how to design and build new facilities. To assess the issues, major supply partners (MSPs) were invited to submit questions to the biomanufacturing members of the Senior...

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Harmonizing the industry and improving confidence through risk-based microbial testing

Harmonizing the industry and improving confidence through risk-based microbial testing

LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of microbiological test data is critically important to ensure the safety of both the pharmaceutical products and the patients who receive them. One approach to ensure the quality of drug products is to implement second-person verification of microbial testing; however, requiring second-person verification of all data is time-consuming...

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Speed to Clinic initiative launches: learning from the COVID-19 pandemic

Speed to Clinic initiative launches: learning from the COVID-19 pandemic

LONG READSpeed to Clinic initiative launches: learning from the COVID-19 pandemic Spurred on by lessons learned from the COVID-19 pandemic, as well as the ever-pressing need to streamline development and get needed medicines into clinics faster, BioPhorum has initiated a Speed to Clinic pathfinder in its Development Group Phorum. This freshly launched initiative has been met with much enthusiasm from members and is a priority topic for the...

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Celebrating achievements and preparing for the long term

Celebrating achievements and preparing for the long term

LONG READPreparing the industry to tackle risk assessment around PUPSITAs the BioPhorum and Parenteral Drug Association (PDA) SFQRM Consortium prepared to move to a BioPhorum Community of Practice at the end of 2020, its members took a moment to reflect on the many accomplishments the coalition had achieved since its inception in 2017. The team set out to tackle industry and regulatory concerns surrounding pre-use, post-sterilization integrity...

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Chain reaction: how the biopharmaceutical supply chain survived the pandemic

Chain reaction: how the biopharmaceutical supply chain survived the pandemic

LONG READChain reaction: how the biopharmaceutical supply chain survived the pandemicThe pressure on the biopharmaceutical industry caused by Covid-19 is unprecedented, especially in the supply of materials. Government-enforced priorities and record demand have led to lengthening lead times, and the impact has been felt throughout the supply chain. In this period of adversity, the industry has responded with a colossal effort to produce and...

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Overcoming unique challenges to support rapid development of diverse products

Overcoming unique challenges to support rapid development of diverse products

LONG READOvercoming unique challenges to support rapid development of diverse productsThe Cell and Gene Therapy (CGT) sector has seen rapid acceleration in development, manufacturing, and financing over the past year. As a relatively new therapeutic area, the potential benefits for CGT for patients are wide-ranging and diverse, from cancer to spinal muscular atrophy to rare genetic diseases. Despite the global turmoil of 2020, the year was a...

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Defining technology strategy and leading innovation

Defining technology strategy and leading innovation

LONG READDefining technology strategy and leading innovationCelebrating five years of the biomanufacturing technology roadmap   Market growth, new product groups, cost pressure, and localized manufacturing trends are significant challenges faced by the biopharmaceutical industry. They are often too great for companies to tackle on their own.  To solve these challenges and lead the industry toward acceleration of technology creation and...

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The Qualification of Small-Scale Models Workstream addresses the gap in industry alignment and regulatory guidance

LONG READThe Qualification of Small-Scale Models Workstream addresses the gap in industry alignment and regulatory guidanceSmall-scale models and their qualification are important steps of biopharmaceutical process development, characterization, and validation. Despite being required by regulatory bodies, there is no guidance on current best practices and companies use many different qualification approaches throughout the industry.Prasad...

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