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Nov 1, 2023 | 
bioprocessonline.com | Aditi Shivarkar |Felix Manstein |Kevin Ullmann
Wonder how to accelerate your perfusion cell line development, media screening and optimization, and early process development? With the Mobius® Breez microbioreactor, you can rapidly collect high-quality data sets by running multiple cell culture experiments simultaneously and independently on your benchtop with only 2 mL working volume. Discover how.
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Oct 30, 2023 | 
outsourcedpharma.com | Ryan Chandanais |Aditi Shivarkar |Peter H. Calcott |Cory Lewis |Louis Garguilo
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. Let's look at each of the nine special designations and what scenarios or drugs/therapies are best suited for each.
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Sep 21, 2023 | 
biosimilardevelopment.com | Fran DeGrazio |Aditi Shivarkar |Victoria Meyer
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Newsletter
| September 21, 2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product.
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Sep 12, 2023 | 
outsourcedpharma.com | Aditi Shivarkar |Louis Garguilo
By Aditi Shivarkar, insightSLICE
Drug–device combination products, also known simply as combination products, are therapeutic or diagnostic products that combine drugs or biologics (such as vaccines or blood products), and a medical device into a single entity. The field’s wide range of applications include drug-eluting stents, prefilled syringes with medications, inhalers with drugs, and transdermal patches with therapeutic agents, among others.
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Aug 25, 2023 | 
bioprocessonline.com | Aditi Shivarkar |Richard Steiner |Marwan Alsarraj
Stem cell assays allow scientists to assess the self-renewal capacity, proliferation rate, differentiation potential, and other characteristics of stem cells. By understanding how stem cells respond to different conditions, scientists can optimize protocols for therapeutic use. Let's look at six emerging trends in using stem cell assays.
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Aug 22, 2023 | 
laboratorynetwork.com | Tim Sandle |Aditi Shivarkar
Stem cell assays allow scientists to assess the self-renewal capacity, proliferation rate, differentiation potential, and other characteristics of stem cells. By understanding how stem cells respond to different conditions, scientists can optimize protocols for therapeutic use. Let's look at six emerging trends in using stem cell assays.
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Aug 21, 2023 | 
drugdiscoveryonline.com | Aditi Shivarkar
By Aditi Shivarkar, insightSLICE
KRAS inhibitors are a class of drugs designed to target the KRAS gene, which is a crucial component of cell signaling pathways involved in cell growth and division. KRAS is frequently mutated in various cancers, including pancreatic, colorectal, and lung cancers, making it one of the most commonly altered oncogenes.
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Jul 24, 2023 | 
cellandgene.com | Aditi Shivarkar
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Discovery
Trials
Regulatory
Outsourcing
Commercialization
Guest Column
| July 24, 2023
By Aditi Shivarkar, insightSLICE
A stem cell assay is a laboratory technique used to evaluate and measure the properties and behavior of stem cells.
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Jun 14, 2023 | 
drugdiscoveryonline.com | Aditi Shivarkar
Guest Column
| June 14, 2023
By Aditi Shivarkar, insightSLICE
Antibody library technologies are methods used to generate diverse collections of antibodies for research, diagnostics, and therapeutic purposes. These technologies enable the screening and identification of antibodies with desired properties, such as high affinity and specificity for a target molecule.
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May 15, 2023 | 
outsourcedpharma.com | Aditi Shivarkar |Louis Garguilo
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Development
Contract Manufacturing
Packaging
Logistics
Market Research
Guest Column
| May 15, 2023
By Aditi Shivarkar, insightSLICE
Generic sterile injectables are drugs that are manufactured for administration through intravenous or intramuscular injection.
