06/04/2021

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

While there are commercially available immunoassay kits to detect and measure this particular protein, the aim here was to develop a fit-for-purpose method, which produced reproducible results within a challenging matrix.

There were a number of factors that had a direct impact on the reproducibility of this assay and were addressed in the following ways:
• With limitations on the availability of the skin sample matrix and the presence of endogenous protein, a surrogate matrix of RIPA buffer was used.
• To maintain sample stability, samples were sliced on dry ice and removed only briefly for weighing.
• Cut samples were homogenised using the Precylls Evolution Homogeniser®, which allowed for the creation of repeatable programs at sub-zero temperatures.
• Additionally, during homogenisation, RIPA buffer, spiked with a protease inhibitor was added to prevent any enzyme degradation.
• To ensure that a similar amount of drug per mg of total protein was generated regardless of the size of sample section taken, a fixed ratio of RIPA buffer was added per mg of skin tissue.

In addition to method parameters normally assessed for a PK assay, such as precision and accuracy, selectivity, parallelism and stability, the qualification of this method also involved the evaluation and optimisation of the homogenization procedure. The use of an automated tissue homogeniser also helped in the generation of a highly reproducible homogenisation process, which then facilitated the completion of the qualification of a fit-for-purpose method.

Please find below the poster for your ready reference:

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30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

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31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

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10/30/2020

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab. The inspection was study-specific and WHO proved evidence that Anapharm’s practices are compliant with WHO Good Clinical Practice & Guidance for organizations performing in vivo bioequivalence studies. There were no observations during the inspection.

About Anapharm Bioanalytics

30+ years’ experience in LC-MS/Bioanalysis and 15+ years’ experience in LBA assays for antibodies and biomarkers, acknowledges Anapharm Bioanalytics as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified and GCP-compliant laboratory in Barcelona.

With a successful regulatory history, having undergone +20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.

MORE NEWS

04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE
31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE

06/10/2020

Monomethyl fumarate

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

05/08/2020

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Such expansion of our services’ portfolio is in response to client’s growing demand for cell-based assays and is aligned with Anapharm’s grow strategy towards providing effective solutions for its clients worldwide.

Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc. The results’ readouts include Absorbance, Fluorescence and Luminescence.

”This is an important addition to our offering and a step forward towards providing better assistance to our clients’ drug Development programs” said Dr. Salvatore Scarpaci, Large Molecule Bioanalysis Director at Anapharm Bioanalytics.

We strive to exceed Sponsor’s expectations by delivering great value services and we look forward to supporting our clients’ evolving needs time after time.

If you are interested in having additional details please let us know.

About Anapharm Bioanalytics

15+ years’ experience in LBA assays for antibodies and biomarkers and 30+ years’ experience in LC/MS-MS bioanalysis, acknowledges Anapharm Bioanalytics as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified and GCP-compliant laboratory in Barcelona.

With a successful regulatory history, having undergone 20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (10+ studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.

For further details about Anapharm Bioanalytics, please visit https://www.anapharmbioanalytics.com/services/ or contact your Business Development representative at +34 93 223 8636.

MORE NEWS

04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE

04/02/2020

Ursodiol, Glycoursodeoxycholic Acid; Tauroursodeoxycholic Acid

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

Octreotide

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

04/01/2020

Metamizole metabolite (4-methylaminoantipyrine)

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

Rivastigmine; NAP 226-90

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

03/31/2020

N-Acetylcysteine

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Barcelona, March 31st, 2020

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been supporting our European and Latin American customers achieving their goals in Brazilian market and will gladly continue our mission of providing high-quality bioanalytical services in the coming years.
Should you have any project that might require our bioanalytical support, please do not hesitate to contact our Business Development team, at contact@anapharmbioanalytics.com.

About Anapharm Bioanalytics

30+ years’ experience in LC-MS/Bioanalysis and 15+ years’ experience in LBA assays for antibodies and biomarkers, acknowledges Anapharm Bioanalytics as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified and GCP-compliant laboratory in Barcelona.

With a successful regulatory history, having undergone 20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.

MORE NEWS

04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

READ MORE
30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

READ MORE
08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

READ MORE