All about Bioanalysis

Nucleic Acids: From Biological Underdog to Biotech Top Dog

The bioanalysis of nucleic acids, especially in biological matrices, is one of the newest services offered by the Kymos Group and carried out at its German subsidiary Prolytic. Maria Fauth, Head of the Oligonucleotides Department, has dedicated her entire academic and corporate career to the research and analysis of nucleic acids. She and Dr. (...)

By Joan Puig de Dou|2024-08-14T11:11:37+02:00February 3rd, 2022|Bioanalysis|Comments Off

Percutaneous Absorption: Like a Second Skin

An important function of the skin is to protect the body from the environment, and it is normally a very effective barrier against external substances. In some cases, however, penetration of active substances (API) into the skin is desired to provide a therapeutic effect. Hence, manufacturers of pharmaceutical topical products must test how well (...)

By Carles Celma|2024-10-24T14:48:36+02:00July 16th, 2021|Bioanalysis, Kymos Group|Comments Off

The revolution in COVID vaccine development

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 (...)

By Joan Puig de Dou|2024-08-14T11:14:55+02:00February 1st, 2021|Bioanalysis|Comments Off

ANIMAL CLINICAL R&D IN TIMES OF COVID-19

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 (...)

By Carles Celma|2024-08-14T10:37:02+02:00June 10th, 2020|Bioanalysis|Comments Off

Immunology: Working together to prepare for the next pandemic

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 (...)

By Joan Puig de Dou|2024-08-14T10:48:31+02:00May 18th, 2020|Bioanalysis|Comments Off

Bioanalysis: Harmonization, Experience and Good Practices

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 (...)

By Joan Puig de Dou|2024-08-30T12:06:44+02:00February 26th, 2020|Bioanalysis|Comments Off

Dr Lluïsa Garcia advises on how to manage N-nitrosamine impurities in sartans

“Face Nitrosamine uncertainty with a flexible analytical CRO and a full risk assessment” Dr Lluïsa García, Kymos Pharma Services There has been much attention surrounding the discovery of N-nitrosamine impurities in blood pressure medicines known as sartans. We explain how this situation has arisen and interview our expert, Dr Lluïsa García, PhD in Organic Chemistry, (...)

By Joan Puig de Dou|2024-08-30T12:02:17+02:00December 10th, 2019|Bioanalysis, CMC|Comments Off

Quality and Equivalence of Topical Products

On October 18, 2018 the EMA published the Draft Guideline on Quality and Equivalence of Topical Products. On June 30, 2019, the period of Consultation will end and it is expected to be in force by the end of the year. The guideline clearly states that regulatory applications based in literature to demonstrate safety and efficacy (...)

By Joan Puig de Dou|2024-08-14T11:13:41+02:00April 28th, 2019|Bioanalysis, CMC|Comments Off

Bioequivalence of Topical Generic Products

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 (...)

By Carles Celma|2024-08-14T21:59:27+02:00August 8th, 2018|Bioanalysis|Comments Off

New FDA Guidance on Bioanalytical Method Validation

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 (...)

By Joan Puig de Dou|2024-08-14T10:54:52+02:00May 25th, 2018|Bioanalysis|Comments Off

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