The Echo Liquid Handler has demonstrated the ability to generate DNA constructs using various assembly chemistries with a miniaturised protocol.
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Clinical trial testing a live biotherapeutic in hospitalised COVID-19 patients suggests the bacteriotherapy could be promising.
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.
Coating the tetanus portion of the DTP vaccine in silica rendered it thermally stable up to 100°C and able to be distributed without refrigeration.
The enterprise announced the initiation of the LY-CoV555 COVID-19 antibody treatment trial at medical centres across the US.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
Earlier this year, the British Biosimilars Association (BBA), the trade body representing the interests of biosimilar manufacturers, welcomed Dr Andrew Ellis as its new Chair. In this interview, Nikki Withers asks why biosimilars are so important for pharma and how he foresees the market evolving in the coming years.