CRB will participate at this year’s ISPE Europe Annual Conference in Madrid, Spain. Focused across four tracks, the event will address topics including innovation in the market, digital transformation, current trends, case studies, and more. It will celebrate contributions the pharmaceutical industry has made over the last two years and discussing strategies for addressing future challenges.
During the event, CRB’s Director of Pharmaceutical Process Technology Dave DiProspero will serve as a keynote session speaker and will also co-present the 2022 Facility of the Year (FOYA) category winners. Additionally, CRB’s Alejandro Kaiser and David Estape, PhD will lead conference sessions on topical areas of expertise.
On Day Two, the FOYA session will see the formal announcement of the 2022 category winners, selected by the judging committee and co-presented by DiProspero. The session will include an overview of the winning projects and highlight specific areas of the project that impressed the judges most. A short question and answer session will follow.
Also on Day Two of the event, CRB’s Alejandro Kaiser will deliver a presentation entitled: ‘A Playbook to Fully Utilise Closed Systems in Modern BioPharma Facilities’. ISPE published the 2nd edition of the Volume 6 Baseline Guideline on Biopharmaceutical Manufacturing Facilities in 2013.
This Baseline Guideline introduced a tangible concept of modern biopharma facilities that are based on closed processing. The concept has revolutionized the strategies used when designing biological API facilities. Kaiser’s presentation provides an introduction to the Process Closure Playbook currently being drafted by a specialised BioPhorum group. The presentation also offers a definition of what is Grade D and what is CNC space used almost exclusively in facilities based on closed bioprocessing.
On Day Three, CRB’s David Estape will deliver a presentation on ‘mRNA Technology – Beyond COVID-19 Vaccine’, which will discuss the technology’s versatility and potential for medicinal products for other applications including cancer. The presentation will reveal key elements that make mRNA such a powerful technology and that define the facility set-up of tomorrow already today, for both: individualised medicines as well as for large volume medical products such as vaccines against infectious diseases.