Biomanufacturing White Papers and Case Studies

91. Minimizing Errors And Saving Time In Drug Receipt Processes 3/20/2019

    The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. 

92. What Clinical Teams Should Know About Changing Trial Logistics 2/27/2019

    The clinical journey is every bit as important as the destination.This paper discusses changing supply logistics and solutions to ensure secure, efficient, cost-effective passage of clinical supplies.

93. Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation 2/11/2019

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

94. Can We Win The War Against Mycoplasma Contamination? 11/12/2015

    Mycoplasma maybe the smallest class of free living microorganism, but the consequences of a contamination in a cell batch during bioprocessing can be huge.

95. Despite An Airport Strike, Marken Preserves The Data Chain 5/4/2014

    Marken collected a shipment from southern Sweden that was bound for next-day delivery in northern Belgium. However, all airline flights into Belgium were cancelled as a result of a strike action by airport workers.

96. Protecting A Temperature-Critical Healing Innovation In Storage And Shipping 11/7/2013

    Mike Whitmore, ABH's logistics manager, explains that the company faced two challenges. First, it was running out of storage space; when operating at maximum capacity, the company can produce more than 300,000 units of Dermagraft per year. Second, keeping its entire inventory in one location posed a risk to the supply.

97. Important Considerations For Implementing A Single-Use Biomanufacturing Strategy 10/18/2013

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

98. Controlled Environment Storage: The Case For Outsourcing Gets Stronger 9/26/2013

    Anyone in business in the current economic climate knows that life is a constant struggle. Financial constraints, limitations on capital budget spend, and the ever-increasing need to reduce costs are all adding to the burden of trying to stay in business – and stay competitive. Inevitably, we all share some common challenges. By Patrick Jackson, Vindon Scientific

99. Better Characterization of Biomolecules Using Agilent AdvanceBio Reversed-Phase Columns 7/2/2013

    Reversed-phase (RP) is one of the three key techniques used in biochromatography and is particularly valuable because of its compatibility with LC/MS detection. And small particle improvements, such as those found in Agilent ZORBAX RRHD 300A, 1.8 um columns, make RP an attractive choice for many biopharmaceutical applications.

100. A 15-Minute Guide To Clinical Trial Document Management And The eTMF 5/30/2013

     At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.