Pharmaceutical Analysis Lab (LAF)

Macroarea: Pharmaceutical Analysis

ERC Sectors: LS7 Applied Medical Technologies, Diagnostics, Therapies and Public Health, PE4 Physical and Analytical Chemical Sciences, PE5 Synthetic Chemistry and Materials 

Research Team

Lab Managers: Gabriella Massolini (Full Professor - Responsible), Enrica Calleri (Associate Professor), Caterina Temporini (Associate Professor), Gloria Brusotti (Assistant Professor), Sara Tengattini (Assistant Professor)

Junior Staff: Francesca Rinaldi (Post-doc); Martina Lioi (PhD student); Isabella Senini (PhD student)


Research Lines

1. Development and Validation of analytical methods in HPLC-UV, HPLC-DAD and HPLC-MS using reverse phase liquid chromatography (RP-LC), hydrophilic liquid chromatography (HILIC), and size exclusion chromatography (SEC) for the analysis of API and related impurities; development of GC-FID and GC-MS methods for the determination of natural substances in complex matrices.

2. Development of integrated LC-LC-MS/MS analytical platforms (CEX, SEC, HILIC, RP) for the structural analysis of proteins of therapeutic interest, such as new antitubercular glycoprotein vaccines and for the characterization of the main post-translational modifications (phosphorylation and glycosylation). Application of these methods to the analytical characterization of biopharmaceuticals with protein, peptide, polymeric, glycoprotein structure (sericin, monoclonal antibodies, fermentation antibiotics, collagen, vesicles, cell lysates) from human cell lines, yeasts, bacteria or plants.

3. Development of analytical methods for binding studies for the characterization of drug-protein interaction and for the study of structure-affinity relationships, using a biochromatographic approaches and surface plasmon resonance (SPR).

4. Development and characterization of enzymatic reactors (bioreactors) on analytical scale for the flow synthesis of drugs, and for the structural simplification of proteins of pharmaceutical interest. Development of integrated chromatographic systems for API biocatalyzed synthesis monitoring.

5. Synthesis, characterization, and application of polymers synthesized using high internal phase emulsions (polyHIPE). Areas of application: chromatographic supports for selective solid phase extraction from complex matrices (waste water), materials for 3D printing, scaffolds for drug delivery.

  • Rinaldi, F., Tengattini, S., Brusotti, G., Tripodo G., Peters B., Massolini, G., Calleri, E. Monolithic Papain-Immobilized Enzyme Reactors for Automated Structural Characterization of Monoclonal Antibodies (2021) Frontiers in Molecular Biosciences, 8, 765683 DOI:10.3389/fmolb.2021.765683
  • Capelli, D., Parravicini, C., Pochetti, G., Montanari, R., Temporini, C., Rabuffetti, M., Trincavelli, M.L., Daniele, S., Fumagalli, M., Saporiti, S., Bonfanti, E., Abbracchio, M.P., Eberini, I., Ceruti, S., Calleri, E., Capaldi, S. Surface Plasmon Resonance as a Tool for Ligand Binding Investigation of Engineered GPR17 Receptor, a G Protein Coupled Receptor Involved in Myelination (2020) Frontiers in Chemistry, 7, art. no. 910 DOI:10.3389/fchem.2019.00910
  • Rinaldi, F., Fernández-Lucas, J., de la Fuente, D., Zheng, C., Bavaro, T., Peters, B., Massolini, G., Annunziata, F., Conti, P., de la Mata, I., Terreni, M., Calleri, E. Immobilized enzyme reactors based on nucleoside phosphorylases and 2′-deoxyribosyltransferase for the in-flow synthesis of pharmaceutically relevant nucleoside analogues (2020) Bioresource Technology, 307, art. no. 123258. DOI: 10.1016/j.biortech.2020.123258
  • Corti, M., Rinaldi, F., Monti, D., Ferrandi, E.E., Marrubini, G., Temporini, C., Tripodo, G., Kupfer, T., Conti, P., Terreni, M., Massolini, G., Calleri, E. Development of an integrated chromatographic system for ω-transaminase-IMER characterization useful for flow-chemistry applications (2019) Journal of Pharmaceutical and Biomedical Analysis, 169, pp. 260-268. DOI: 10.1016/j.jpba.2019.03.020.
  • Marrubini, G., Tengattini, S., Colombo, R., Bianchi D., Carlotti F., Orlandini S., Terreni M., Temporini, C., Massolini, G. A new MS compatible HPLC-UV method for Teicoplanin drug substance and related impurities, part 1: Development and validation studies. (2019) Journal of Pharmaceutical and Biomedical Analysis 162, pp. 185-19. DOI:10.1016/j.jpba.2018.09.040.
  • Tripodo, G., Marrubini, G., Corti, M., Brusotti, G., Milanese, C., Sorrenti, M., Catenacci, L., Massolini, G., Calleri, E. Acrylate-based poly-high internal phase emulsions for effective enzyme immobilization and activity retention: From computationally-assisted synthesis to pharmaceutical applications (2018) Polymer Chemistry, 9 (1), pp. 87-97. Cited 13 times. DOI: 10.1039/c7py01626c
  • Rational design, preparation and characterization of recombinant Ag85B variants and their glycoconjugates with T-cell antigenic activity against Mycobacterium tuberculosis Rinaldi F., Tengattini S., Piubelli L., Bernardini R., Mangione F., Bavaro T., Paone G., Mattei M., Pollegioni L., Filice G., Temporini C., Terreni M. (2018) RSC Advances 41, 23171-23180 DOI:10.1039/c8ra03535k
  • S. Tengattini, E. Domínguez-Vega, C. Temporini, T. Bavaro, F. Rinaldi, L. Piubelli, L. Pollegioni, G. Massolini, G. W. Somsen Hydrophilic interaction liquid chromatography-mass spectrometry as a new tool for the characterization of intact semi-synthetic glycoproteins (2017) Analytica Chimica Acta 981 pp 94-105. DOI:10.1016/j.aca.2017.05.020
  • Brusotti, G., Calleri, E., Milanese, C., Catenacci, L., Marrubini, G., Sorrenti, M., Girella, A., Massolini, G., Tripodo, G. Rational design of functionalized polyacrylate-based high internal phase emulsion materials for analytical and biomedical uses (2016) Polymer Chemistry, 7 (48), pp. 7436-7445. DOI: 10.1039/c6py01992g
  • Calleri, E., Ceruti, S., Cristalli, G., Martini, C., Temporini, C., Parravicini, C., Volpini, R., Daniele, S., Caccialanza, G., Lecca, D., Lambertucci, C., Trincavelli, M.L., Marucci, G., Wainer, I.W., Ranghino, G., Fantucci, P., Abbracchio, M.P., Massolini, G. Frontal affinity chromatography-mass spectrometry useful for characterization of new ligands for GPR17 receptor (2010) Journal of Medicinal Chemistry, 53 (9), pp. 3489-3501. doi: 10.1021/jm901691y

National Collaboration



Prof. Stefano Capaldi, Department of Biotechnology, University of Verona (Italy)
Prof. Manuela Bartolini Department of Pharmacy and Biotechnology Alma Mater Studiorum University of Bologna, Bologna (Italy)
Prof. Antonio Lavecchia, Università degli Studi di Napoli “Federico II”, 80131 Napoli (Italia)
Dott. Davide Capelli, Istituto di Cristallografia, Consiglio Nazionale delle Ricerche Montelibretti, 00015 Monterotondo Scalo, Roma (Italia)
Prof. Loredano Pollegioni, The Protein Factory, Centro Interuniversitario Politecnico di Milano, ICRM CNR Milano e Università dell’ Insubria, Milano (Italia)
Prof.ssa Giovanna Speranza, Dipartimento di Chimica, Università di Milano, Via Golgi 19, 20133 Milano (Italia)
Dr. Gianluca Sferrazza Istituto di Farmacologia Traslazionale, Consiglio Nazionale delle Ricerche, Roma
rof. Ferdinando Auricchio, Department of Civil Engineering and Architecture, University of Pavia
Prof. Maurizio Mattei Dep. of Biology and Director of Centro Interdipartimentale per la Medicina Comparata, le Tecniche Alternative e l'Acquacoltura; University of Rome Tor Vergata
Dott.ssa Cristina Sottani, Istituti Clinici Maugeri, Pavia (Italy).



Gnosis by Lesaffre S.p.A; Via Lavoratori Autobianchi, 1 20832 Desio (MB)
Special Product’s Line S.p.A; Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
Savio Industrial S.p.A;. Via Emilia, 21, 27100 Pavia (PV)
IZO S.p.A; via Loc. Balduca, 27013 Chignolo Po (PV)


International Collaboration



Prof.ssa Q.B. Cass, Departamento de Química, Universidade Federal de São Carlos, Cx Postal 676, São Carlos 13565-905, São Paulo, Brazil.
Prof. Jean-Luc Veuthey , Prof. Serge Rudaz, Dr. Davy Guillarme, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Boulevard d’Yvoy 20, 1211 Geneva 4, (Switzerland)
Prof. Govert Somsen, Analytics of Biomolecular Interactions Group, Department of Chemistry and Pharmaceutical Sciences, Amsterdam Free University (VU) (Olanda)
Prof. M. Przyblyski, Steinbeis Center for Biopolymer Analysis and Biomedical Mass Spectrometry, Rüsselsheim (Germany)
Dr. R. Moaddel, Biomedical Research Center, National Institute on Aging, National Institutes of Health 251 Bayview Boulevard, Suite 100, Baltimore, MD 21224-6825 (USA)
Dr. Marcela Cristina de Moraes, Universidade Federal Fluminense, Instituto de Química Departamento de Química Orgânica; BioCrom - Cromatografia de bioafinidade e Química ambiental. Outeiro de São João Batista, s/n - sala 206A CEP 24020-141 Niterói/RJ (Brazil)
Prof. Maria Josefa Hernaiz Gomez-Degano Departamento de Química en Ciencias Farmacéuticas, Plaza de Ramón y Cajal, s/n Ciudad Universitaria 28040 – MADRID (Spain)


Dr. Benjamin Peters Instrumental Analytics R&D, Merck KGaA, Darmstadt, Germany. Frankfurter Str 250, 64271 Darmstadt, (Germany);

Funded active projects

Project HUB “Approvvigionamento energetico e gestione della risorsa idrica nell’ottica dell’Economia Circolare”

CE4WE (Circular Economy for Water and Energy), ID 1139857. Research Contract (3-yrs) supported by Gnosis by Lesaffre. “Characterization of human type II collagen from different sources, and vitamin K impurity profile”.

Research Contract with Institute of Translational Pharmacology, National Research Council, Rome “Tecnological transfer and analytical characterization of a new biological drug for preclampsy”.

Research Contract with Savio “Development and validation of an analytical method for the analysis of VitD in oil products”.



  • Development and validation of analytical methods in HPLC-UV, HPLC-DAD, HPLC-MS. Determination of synthetic and/or natural compounds in complex matrices, such as drugs, foods or cosmetics. Identification, control of impurities.
  • Development of analytical methods for the characterization of biological macromolecules with protein, peptide, polymeric, glycoprotein structure.
  • ευFAN spinoff: consultancy in the pharmaceutical and agri-food sector.


  • n.2 HPLC (Agilent) with DAD detector;
  • n. 1 HPLC (Agilent) with UV-Vis detector n. 1 HPLC (Agilent) for 2D-LC; n.1 HPLC (HP) With FLD; n.1 nano-capillary LC (Dionex) with ESI-LTQ (Thermo Fisher).
  • n.2 GC-MS (Agilent)
  • n.1 SPR Instrument (Creoptix® WAVEsystem - Optical biosensor platform)