All about bioanalysis

The new COVID-19 vaccine developed by Pfizer/BioNTech was approved by the EMA last December and now Moderna’s is following suit. Both are based on mRNA technology and represent a very different type of vaccine compared to traditional ones. While the general public is just beginning to discover mRNA technology, Dr. Meike Saul is an (...)

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The COVID-19 pandemic has paralyzed many aspects of our lives. However, the R&D of new pharmaceutical products for animal health cannot stop as many human diseases posing a threat have an animal origin. KYMOS and its partners have a unique insight into how the industry is adapting to speed up animal studies during these (...)

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Now more than ever, immunology is a hot topic as we face the numerous challenges of the COVID19 pandemic. The world is patiently awaiting new therapies and vaccines to combat this disease in hopes of returning some sense of normalcy to our lives.  KYMOS’ immunology expert, Dr. Carles Morte, shares his outlook on the future (...)

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The importance of ICH M10 harmonization Our head of Bioanalysis, Digna Tost has 30 years’ experience working in bioanalysis solutions. Here, she comments on the current ICH harmonization of bioanalytical global guidelines and the added value of having a solid team and upholding good practices. The International Council of Harmonisation’s (ICH) M10 minutes have been (...)

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On September 2018, FDA revised the status of Topical Generic Products and their future perspectives in a two-day Conference on Complex Generic Drug Product Development Workshop. One year before, on October 2017, FDA held a previous Workshop on Topical Dermatological Generic Drug Products. Find below the main ideas discussed during the conference about the (...)

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The FDA has issued a Guidance for Industry entitled “Bioanalytical Method Validation”. This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods.  Bioanalytical methods provide critical data to support the safety and efficacy of drugs and biologic products. The final guidance describes the (...)

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Over the past 25 years the criteria required for bioanalytical methods has evolved significantly. The harmonization of bioanalytical methods requirements started in 1990 during the AAPS and FDA Crystal City Meetings. In 2000 the Crystal City II Meeting laid the foundations of the 2001 FDA Guidance on Bioanalytical Method Validation. In 2011 EMA launched his (...)

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