Search results for " microbial"
Article
Design and Qualification of Single-Use Systems
It includes handling and other ergonomic properties, accessibility for installation and removal, microbial barrier and physical and fitment (leak) integrity properties, sterilizability, drainability, …
Poster
Process economy and production capacity using single-use versus stainless steel fermentation equipment
This white paper compares production capacity and process economy between stainless steel and single-use equipment in microbial processes. Economy simulations were based on an E. coli Dab process. P…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
The results over the past 10 years tell show that outsourcing is not only increasing across traditional systems including mammalian cell culture and microbial fermentations, but also across newer syst…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…
Article
Sterilization Trends for Single-Use Consumables
…al and external surfaces of materials, which is a benefit for processes that require a high level of microbial decontamination,” Eatmon contends.
Alternative methods are considered, of course, wh…
Article
Digitalization: The Route to Biopharma 4.0
In microbial cell cultures, scale down models such as micro well plates (3) and deep well plates are employed, whereas shake tubes/flasks are widely used in mammalian cultures (4). However, most of th…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Companies, such as Sutro Biopharma, a US-based clinical-stage drug discovery, development, and manufacturing company, for instance, are already making microbial cell-free extracts and products at scal…
Article
Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
Here, we describe a microbial challenge test with a concentration of 1-M NaOH to mimic typical sanitization practices employed by the biopharma industry for a broad range of resins. The final version …
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Thus, good sanitation methods and familiarity with the most likely microbial contaminant species present in the immediate environment are needed to address bioburden. Using pre-sanitized single-use co…
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…