12/17/2017

New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone

A new method has been successfully developed and validated for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS with LLOQ of 2 pg/mL and 5 pg/mL respectively.

The method involves a liquid-liquid extraction procedure and a subsequent derivatization procedure. Estradiol, Estrone and internal standards are measured by reversed phase ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS).
The possible metabolite back conversion has been evaluated during method validation.
This method has been successfully used to analyze samples from different clinical studies and the incurred sample reproducibility has met all acceptance crieria.

The development of this assay adds to the list of high sensitivity methods at Anapharm together with Tiotropium, Fluticasone, Salmeterol, Formoterol or Ethinyl Estradiol.

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09/07/2018 11:01

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certificate.
The renewed certification is valid until 11th June 2020.

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02/07/2018 11:53

Anapharm Bioanalytics GLP Certificate Renewal

After the corresponding regulatory inspection Anapharm Bioanalytics has renewed once more its Certificate for Good Laboratory Practice Principles (GLP). The company is under GLP certification since its foundation. The present certificate is valid until June 2020.

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15/06/2018 14:08

Anapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials

The presentation of our Bioanalytical Coordinator, Araceli Castillo, was focused on two trending topics on Bioanalysis: the final guidance on Bioanalytical Method Validation published by the US FDA on May 21st, 2018 and the progress on the new guideline ICH M10 for the harmonization of bioanalytical method validation.

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05/15/2017

Anapharm Europe Announces Rebranding & Laboratory Expansion

We are pleased to announce that as part of our rebranding strategy, our brand name has now changed from Anapharm Europe to Anapharm Bioanalytics.

Our rebranding project is built on many improvements we have made to our services as well as on the international growth of our business. We have recently completed the expansion of our facilities in Barcelona increasing our lab space by 50%, acquired two additional ABSciex 6500 LC-MS/MS/UPLC platforms, upgraded software and hired additional staff in order to offer our clients increased capacity and improved study timelines for both small and large molecule bioanalysis.

The name change does not affect the legal personality of the existing entity (namely Anapharm Europe S.L.U.) which retains its rights and obligations in all existing legal relationships with third parties as well as the regulatory track record achieved to date including GLP and ANVISA certifications as well as FDA and EU-GCP inspection history.
What it means for our clients is that it is business as usual. We will continue to execute projects with the same, if not better, level of excellence and quality standards you have come to experience.

Our e-mail addresses will change but our phone numbers and headquarter’s address will remain the same. You can continue to connect with us online at our new website www.anapharmbioanalytics.com.

We take this opportunity to thank all our valued clients for their continued trust and look forward to delivering great value services that meet your expectations time after time.

MORE NEWS

09/07/2018 11:01

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certificate.
The renewed certification is valid until 11th June 2020.

READ MORE
02/07/2018 11:53

Anapharm Bioanalytics GLP Certificate Renewal

After the corresponding regulatory inspection Anapharm Bioanalytics has renewed once more its Certificate for Good Laboratory Practice Principles (GLP). The company is under GLP certification since its foundation. The present certificate is valid until June 2020.

READ MORE
15/06/2018 14:08

Anapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials

The presentation of our Bioanalytical Coordinator, Araceli Castillo, was focused on two trending topics on Bioanalysis: the final guidance on Bioanalytical Method Validation published by the US FDA on May 21st, 2018 and the progress on the new guideline ICH M10 for the harmonization of bioanalytical method validation.

READ MORE