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Lilly introduces cheaper generic insulin in the US
The generic version will cost 50 percent less that the current Humalog list price...
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Formulation
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
news
Interphex New York: FPS confirm their presence for 2019
FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions (sterile and highly toxic API)...
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Computational method could reduce the risk of drug formulations
A team of researchers have developed a computational method using an algorithm to develop formulations for drugs so they function properly...
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Making liposomal formulations for the delivery of RNA vaccines
A Dolomite Microfluidics’ set-up for high throughput single cell encapsulation is helping researchers at the Department of Medicine at Imperial College, London, to develop novel liposomal formulations for RNA vaccines targeting diseases such as HIV, influenza, rabies and chlamydia...
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Freeze-dried TB vaccine candidate enters Phase 1 human clinical trial
A vaccine that does not require a cold chain could be much more easily distributed to communities in need…
whitepaper
Whitepaper: Solubility: Importance, measurements and applications
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
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FDA grant to help increase generic drugs delivered intravaginally or by IUD
Of the 21 drugs designed for delivery directly to the female genital tract, only four have a cost-effective, generic equivalent...
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Inhaled dry powder formulation of treprostinil works well in PAH patients
A formulation of treprostinil as an inhaled dry powder has proven to be safe and effective, as reported in the safety analysis of a Phase III trial...
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Diversifying drug development with a metal catalyst
Researchers have outlined a method of formulating drug-like aliphatic and aromatic carbon-hydrogen scaffolds into drugs using a metal catalyst...
article
Real-time PCR detection of S. aureus in pharmaceutical products
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
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Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
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Formulation, Development & Delivery In-Depth Focus 2018
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
whitepaper
Application Note: Tracking fate and purge of impurities and calculating carryover
The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.
news
Using graphene as a tunable ion filter
NIST researchers have shown how graphene can be modified with pores and used as an ion filter, and could be adapted for use in drug delivery systems...
