02.25.21 Developing Future Delivery Models For ATMPs
Seeq is hosting a live virtual event featuring pharmaceuticals and life sciences experts from Eli Lilly, Lonza, Amgen, and more on March 10, 2021. Mark your calendars and register to hear how other companies in your industry are using advanced analytics technology to turn their data into insights, drive process improvement, and increase profitability.
This is a live event, and the presentations will not be accessible afterward. Save your spot today spaces are limited!
Featured Editorial
By Erich H. Bozenhardt and Herman F. Bozenhardt
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh s
02.16.21 Do These Recent Warning Letters Signal A Shift In FDA Enforcement?
Upload an image of your current/old CO2 incubator for a chance to win a brand new FREE NuAire In-Vitrocell NU-5810 CO2 Incubator. Other prizes include a monthly drawing for a branded Under Armour backpack, Camelbak metal water bottle, and various gift cards. All entries will receive a FREE NU-1582 CO2 Incubator Castered Platform with your next NuAire CO2 Incubator purchase. Contest valid until 7/31/2021. Restrictions apply.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
01.19.21 Centrifugal Sifters Ideal For Quality Control Of Incoming Food Materials Case Study | By Lisa Thomas, Schenck Process LLC
Manor Bakeries needed new sifters to enter the organic cake market. The addition of sifters allowed them to screen incoming flour and remove any hard agglomerates formed during storage. Case Study | Kaeser Compressors, Inc.
While compressed air never comes into contact with Parmesan cheese, it operates many of its processing, transport, and quality control machines to meet strict requirements for food production. Case Study | Mettler-Toledo Product Inspection
Staying on top of technology in a competitive marke
01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies
This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality.