Tuesday, September 6, 2022 Daily Archives

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

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Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts to a biopharmaceutical after administration. Pharmacokinetic studies (PK) measure the variations of drug levels in the body as a function of time and are an essential part of the drug development process. Properly designed PK studies…

September 6, 2022

Ilya secures IP position for modified bacteria immunotherapy candidates

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Ilya Pharma has secured the IP position for ILP100 – a candidate immunotherapy for various skin and mucosal disease – with patents in India, China, Australia, and the US. The patents mean the company’s method for using modified bacteria for treatment of both mucosal and cutaneous wounds in humans and animals has patent protection in all major markets according to CEO Evelina Vågesjö. She told BioProcess Insider “all commercial activities are covered,” explaining that the patents cover the general use…

September 6, 2022

#ATE22: The European CGT landscape in Tweets

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Advanced Therapies Europe (#ATE22) took place in London, UK, last week. BioProcess Insider was there, as were biopharma’s social media army. We present the best from the Twittersphere.   Before we consider and celebrate #CGT in a #EuropeanMarket at out #AdvancedTherapiesEurope event next month, take a look at this handy infographic with 5 Disruptive Strategies for Market & Patient Access in Europe. Do you agree with them? Take a look 👇https://t.co/EvBfHAFRvs — Phacilitate (@Phacilitate) July 13, 2022 Honoured to be…

September 6, 2022

Host cell protein impurities in viral vector manufacturing: a critical quality attribute for product efficacy and safety

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Viral vector manufacturing processes require rigorous analytics, including testing for process-related impurities such as host cell proteins (HCP), host cell DNA, growth media additives and enzymes used in viral vector purification processes [Cellular and Gene Therapy Guidances]. Even after multiple purification steps, significant levels of HCP impurities can be present. While low levels of most impurities can be inconsequential, patient safety demands that HCPs be eliminated or reduced to the lowest levels practical to prevent problems such as adverse immune…

September 6, 2022