Hello <<First Name>>,
Welcome to the BioPhorum newsletter. Each month we cover news and developments from across the industry. This month we look at:
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The latest results from biomanufacturers and supplier companies who have created a user requirements specification (URS) for a harvest clarification solution to handle ultra-high-density mammalian cell cultures. This URS should improve business drivers of cost, speed, quality and flexibility.
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How several companies are poised to follow the recommendations outlined by the ARMM team on modernizing Environmental Monitoring in grade A settings.
As always, we welcome your feedback - email communications@biophorum.com |
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The BioPhorum and USP collaborative journey to new standards
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BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.
To this end, USP is engaging with industry to understand its pain points, its challenges and where there is the potential for new standards.
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Harvest clarification URS
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The BioPhorum Harvest Clarification team has created a user requirements specification (URS) for a harvest clarification solution that will handle ultra-high density mammalian cell cultures.
Cell separation technologies can be challenging. They are not robust or cost-effective enough to handle ultra-high density, cell culture batch harvests, especially in single-use processing.
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Companies poised to follow ARMM recommendations
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The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent particle counters (BFPCs) enable continuous monitoring, provide more comprehensive coverage of the air and provide real-time detection of air-borne micro-organisms.
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Hear the latest news and views from BioPhorum members at upcoming BPI Conferences
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We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new approaches to some of the largest practitioner audiences in the industry. The partnership continues with several BioPhorum member companies presenting at the upcoming BPI Boston and BioProduction 2019 meetings, covering key topics such as single-use equipment, technology roadmaps, big data, automation and novel technologies.
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New BioPhorum members this month
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The Cell & Gene Therapy Phorum continues to grow its membership with the introduction of Ultragenyx Pharmaceutical. Founded in 2010, the company has rapidly built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need.
Joining the Supply Partner Phorum this month is Saint-Gobain, a world leader in the development of innovative materials and components, including customized single-use solutions for the biopharmaceutical market.
Finally, Allergan adds membership of the IT Phorum to its portfolio as it is currently part of the Fill Finish and Supply Partner Phorums. Allergan is developing a digital strategy and roadmap and its Digital and IT leaders look forward to collaborating and sharing their experience with other members in their transformation journey.
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Risk, Business Continuity Management,
Loveland, Colorado, 7-9 May - to develop a best practice guide to risk management in the supply chain with supporting communication and implementation plan as a foundation to business continuity management.
Environmental Monitoring in a Modern Drug Product Facility,
Vienna, Austria, 14-16 May - to draft version two of the harmonized Environmental Monitoring tool kit and engage key opinion leaders from European agencies.
Extractables, Uppsala,
Sweden, 14-16 May - to continue to make extractables data required by end users readily available and by doing so increase its value.
Lean Qualification Validation,
Gaithersburg, Maryland, 4-6 June - focus on establishing the industry's requirements for a URS of the future with a paper produced 6-8 weeks after meeting closes.
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BioPhorum IT leaders’ meeting,
Dublin, Ireland, 4-6 June - to include visit to Pfizer flagship digital site, and work on emerging pipeline opportunities such as IT challenges relating to CGT, modular small batch manufacturing.
Joint Audit Program,
Miami, Florida, 4-6 June - to review sprints qualitative and quantitative data prior to final sprint check and adjust implementation and improvement. Review outlined consensus paper and measurements for success.
Human Performance,
Oakland, California, 4-6 June - to review results, outlines for papers, review value tracker for human performance (HuP) and HuP Roadmap.
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