Publication

Viewing related articles

Control of Empty, Full and Partially Filled Capsids – BioPhorum establishing an Industry Position on this Critical Quality Attribute.

Control of Empty, Full and Partially Filled Capsids – BioPhorum establishing an Industry Position on this Critical Quality Attribute.

LONG READControl of empty, full and partially filled capsids BioPhorum establishing an industry position on this critical quality attributePosition A consensus of BioPhorum member companies reject a proposed blanket minimum specification for percentage empty AAV capsids. Presently, it is premature and impractical to set a minimal specification of <30% empty capsids to apply to all AAV-based gene therapies in development.BioPhorum calls upon...

read more
Ask BioPhorum – a second brain for BioPhorum members

Ask BioPhorum – a second brain for BioPhorum members

Whilst the filling and finish process is straightforward to describe, it is exquisitely complicated to get right and be assured and assure health authorities that the product reaches stringent quality standards. Even small deviations from standards can result in expensive losses and delay supply to patients of vital therapies.  Experience and expertize matter.  Ask BioPhorum is a valued member resource which enables subject...

read more
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...

read more
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...

read more
The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Considerations for a viral inactivation step, BioPhorum’s Drug Substance Closed Systems in CNC workstream addressed viral segregation of manufacturing steps relating to the purification process. In this follow-up paper, published by BioProcess International, the workstream looks more...

read more
Celebrating achievements and preparing for the long term  

Celebrating achievements and preparing for the long term  

LONG READCelebrating achievements and preparing for the long termAs 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...

read more
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...

read more
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...

read more

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...

read more

How industry is reacting to the Covid-19 pandemic

LONG READHow industry is reacting to the Covid-19 pandemicKeeping in touch with peers and colleagues has never been more important. Following the postponement of meetings such as the annual Executive BioPhorum meeting, coupled with the heightened need for communication between industry leaders, BioPhorum established the Senior BioPhorum Connect – a group for senior leaders to share ideas, discuss problems and find solutions to counter the...

read more