Application Notes & Case Studies
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Cultivation Of Sf9 Insect Cells And rSEAP Expression In The HyPerforma Rocker Bioreactor
1/5/2021
This application note describes the cultivation of Sf9 suspension cells in the Thermo Scientific™ HyPerforma™ Rocker Bioreactor with a maximum working volume of 5.0 L.
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Reducing Mixing Times For Pharmaceutical Creams And Ointments
12/30/2020
Cream or ointment products can be either a water in oil (w/o) or oil in water (o/w) emulsion, consisting of waxes, emollients and lubricants dispersed in an oil phase, and a water phase containing emulsifying, stabilizing and thickening agents, preservatives and in some cases, colorant. Active ingredients are dispersed in either phase or added when the emulsion has been formed and allowed to cool. Read how to reduce mixing times while improving product uniformity and consistency.
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Efficient Particle Size Reduction, Mixing And Homogenization Steps For OSD Manufacturing
12/30/2020
Assay of products such as pharmaceutical suspensions and tablet coatings is a critical part of the quality assurance process. In some cases every batch of each product has to be tested, requiring 100% repeatability of results. Preparation of samples may involve disintegration of solids such as tablets, dispersion of powders into liquids, intimate mixing of liquid/liquid or liquid/solid components to accelerate reactions, etc. The correct mixer mixer can carry out these duties with great efficiency and repeatable results.
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Agglomerate-Free Dispersion For Hand Sanitizers
12/29/2020
One of the key steps in the manufacturing process of hand sanitizersis preparation of the gel. Obtaining an agglomerate-free dispersion is essential to ensure a clear, bright gel after neutralization but low density powders such as Carbopol can be difficult to incorporate into liquids with a conventional agitator, and this can lead to dusting problems and aeration. The high shear mixing of a Silverson mixer ensures rapid incorporation and dispersion of powders to form an agglomerate-free solution, with minimized aeration.
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Mixing Selection Considerations For Pharmaceutical Tablet Coating Operations
12/29/2020
There are various different types of pharmaceutical tablet coatings including traditional sugar-based coatings, film coatings and enteric coatings. Whichever type of coating you're manufacturing, a Silverson high shear mixer will give you a uniform, consistent mix overcoming common processing problems such as flecking caused by uneven dispersion of colorant.
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Lessons Learned Executing A Closed Connected Processing From Start To Finish
12/22/2020
Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.
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The Value Of Reliability Assessments And Benchmarketing In Life Sciences
12/21/2020
A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance
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Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track
12/7/2020
Retrophin is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.
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Upstream Platform For Continuous Lentiviral Vector Production
12/1/2020
Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.
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Industrialization And Scale-Up Of Drug Delivery System
11/30/2020
A pharmaceutical company and their product design partner were in need of a contract manufacturer capable of supporting the device development, injection molding, tooling, supply chain logistics and scale up automation strategy. The customer had developed a novel breath actuated pulmonary device and they were looking for the right manufacturer to assist them with product development refinement, samples for clinical trials and ultimately commercialization.