Welcome message

Welcome to the Summer School on Pharmaceutical Analysis!

In the last two decades, several innovative therapeutic approaches and drug modalities have come to light. However, advanced therapies still face high-level analytical challenges. As a new drug product develops, associated analytical methods also need to develop in parallel to ensure that the finished drug product meets the required quality standards. Failure to meet established quality standards can lead to the loss of the desired therapeutic effect and the appearance of toxic and adverse reactions, putting the final users at risk and wasting financial resources.

The focus of the 2024 and 2025 editions of the Summer School on Pharmaceutical Analysis will be on the specific aspects and analytical challenges associated with consolidated and emerging advanced therapies. In particular, document number one will cover New therapeutic approaches, new analytical challenges: peptide- and protein-based drugs.

Lectures will be delivered by recognized experts from the academic and industrial sectors. A list of confirmed speakers is available in the "Meet our Speakers" section.

The School's social activities are planned to promote networking and interaction between participants and lecturers. Due to this, the number of participants in attendance is limited to 80 to maximize these aspects.

We are committed to making SSPA2024 a tremendous opportunity for you to enhance your scientific competitiveness while also providing an enjoyable and friendly experience.

Join us in Rimini and take advantage of this opportunity to expand your knowledge of advanced pharmaceutical analysis, approaches, and challenges.

Manuela Bartolini
Chair of SSPA
Department of Pharmacy and Biotechnology, Alma Mater Studiorum University of Bologna

 
Main SSPA2024 Topics

Current status and perspective of biological/biotechnological drugs
Analytical challenges for biological drugs
Cleaning Verification
Analysis of “High‐risk” host cell proteins (HCPs)
GMP characterization of peptides, proteins, and antibodies
Glycosylation profiling
Stability studies
Multi-Attribute Methods (MAMs)
LBA method development and validation in biological matrices
Analysis of antibodies in biological matrices
Bioanalysis of Antibody-drug conjugates
Analytical method for the evaluation of immunogenicity
Case studies

The Summer School on Pharmaceutical Analysis (SSPA) is organized by the Divisione di Chimica Farmaceutica, Società Chimica Italiana (Division of Medicinal Chemistry, Italian Chemical Society) and sponsored by the European Federation for Medicinal Chemistry and Chemical Biology (EFMC).

Divisione di Chimica Farmaceutica, Società Chimica Italiana (Division of Medicinal Chemistry, Italian Chemical Society)
European Federation for Medicinal Chemistry and Chemical Biology

Location

Rimini (IT)

Date

18th-20th Sept 2024

Speakers

14 Drug Discovery Professionals

Tickets

80 Students

Program

The scientific program can be downloaded here (Printer friendly version).

Quality control on novel biotech drugs: just routine or real science?

Medical Technology Lab, Milano, Italy

Abstract
Biological Quality Control in Biotechnological Products: Innovative Approaches and regulatory guidelines updates

Merck R.B.M., Ivrea, Italy; an affiliate of Merck KGaA, Darmstadt, Germany

Abstract
Analysis of ´High-Risk´ Host Cell Proteins (HCP)

Philochem AG, Zurich, Switzerland

Abstract
The analytical toolbox & the protein wonderland: deep dive into the early stages of drug discovery

Chiesi Farmaceutici, Italy

Abstract
Characterization of Therapeutic Peptides, Proteins, and Monoclonal Antibodies

Novartis Pharma AG, Basel, Switzerland

Abstract

10.30-11.00   Coffee break

Analytical Characterization and Bioanalytical Assays for Antibody Drug Conjugates Development

Merck R.B.M., Ivrea, Italy; an affiliate of Merck KGaA, Darmstadt, Germany

Abstract
Trastuzumab and its Adcs: the Impact of Conjugation on Stability and Functionality

NanoTemper Technologies, Munich, Germany

Abstract

L
U
N
C
H

T
I
M
E
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Analytical Approaches for Glycoprotein Analysis

Department of Drug Sciences, University of Pavia, Pavia, Italy

Abstract
Method Development and Validation of Ligand Binding Assays Using Biological Matrices

Frontage Europe S.r.l., Nerviano, Italy

Abstract

15.40-16.10   Coffee break

16.40-17.40  PhD presentations
Bioactive compounds from non-psychoactive Cannabis sativa L. as innovative therapeutic agents against cancer cell proliferation and oxinflammation

Clarissa Caroli, University of Modena and Reggio Emilia, Modena, Italy
Abstract


Novel approach for assessing the GPx-like activity of natural and semisynthetic compounds: a revised version of the Iwaoka’s assay

Chiara Collevecchio, University of G. D’Annunzio of Chieti-Pescara, Chieti, Italy
Abstract


Valorization of by-products from agri-food supply chains for the development of functional ingredients and nutraceuticals

Larissa Della Vedova, Università degli Studi di Milano, Italy
Abstract

Immunogenicity Evaluation in Drug Development

Aptuit (Verona) S.r.l, an Evotec Company, Italy

Abstract
Multi-Attribute Method: implementation, challenges and applications

National Institute of Bioprocessing Research and Training, Dublin, Ireland

Abstract

11.00-11.30   Coffee break

Analysis of Mhtt (Mutant Protein of Huntington Disease) to Support Clinical Studies

Aptuit (Verona) S.r.l, an Evotec Company, Italy

Abstract

L
U
N
C
H

T
I
M
E
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Plasma derived product stability study design. Evaluation of shelf life, comparability approach to support process/product changes post-licensure, lean approach

Kedrion S.p.A, Italy

Abstract
14.10-15.50  PhD presentations
Leveraging cross-linking mass spectrometry for modeling antibody-antigen complexes

Andrea Di Ianni, University of Turin, Torino, Italy; Merck Serono RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany
Abstract


Development of an advanced analytical platform for the characterization of recombinant human collagen produced by yeasts for therapeutic use

Martina Lioi, University of Pavia, Pavia, Italy
Abstract


Valorization of by-products from agri-foods for pharmaceutical, cosmetics, and nutraceutical applications

Cristina Terenzi, Alma Mater Studiorum University of Bologna, Rimini, Italy
Abstract


Recombinant protein analysis using innovative orthogonal characterization techniques

Isabella Senini, University of Pavia, Pavia, Italy
Abstract


Application of omics approaches in drug discovery and biomarker identification

Beatrice Zoanni, Università degli Studi di Milano, Italy
Abstract

Location

The SSPA is housed in Aula 7 of the Alberti Complex (Aula Alberti 7), via Carlo Cattaneo 17, Rimini. Venue location is mapped here below. The school venue is conveniently located at a walking distance from the rail station and in Rimini city center.

By car

From North: A1 Motorway Milan – Bologna, then A14 Motorway Bologna – Rimini
From South: A14 Motorway Bari – Rimini
Exit: Rimini Sud (for Rimini centre)

By train

Rimini is well connected by train to all the main cities in central and northern Italy. High speed trains connect Rimini to Bologna (1 h), Milan (2.5 h), Florence (2 h), Ancona (1 h) and Rome (4 h) several times a day.
Main railway station: Piazzale Cesare Battisti
Tickets can be bought on-line through the Italian railway website.

By plane

The city airport (‘Federico Fellini’ International Airport) is located in Miramare di Rimini.
Federico Fellini International airport in Rimini Federico Fellini International www.riminiairport.com
Closest Internationl airport is the Bologna International airport www.bologna-airport.it<

Meet Our Speakers

Martino Benvenuti

Martino Benvenuti
 

Nanotemper Technologies GmbH, Munich, Germany
Abstract  |  


Martino is a Technical Consultant at NanoTemper Technologies GmbH responsible for interacting with academic institutions in Germany, Norway and Sweden since 2021. He has a B.Sc. and a M.Sc. in Industrial Biotechnology at the University of Milano-Bicocca (Italy) and a Ph.D. in Chemistry at the University of Aix-Marseille (France). During his studies Martino has acquired expertise in characterizing metallo-enzymes for biocatalytic reactions by using biochemical and biophysical methods and techniques.

Sara Carillo

Sara Carillo
 

National Institute of Bioprocessing Research and Training, Dublin, Ireland
Abstract  |  


Dr. Sara Carillo completed her PhD in Chemical Sciences in 2013 at the University of Naples Federico II focusing on the structural characterization of polysaccharides and glycoconjugates from Gram-negative bacteria via NMR and mass spectrometry techniques. In 2015 she joined CCL group in NIBRT working on the understanding of the effects of extractables and leachables from single-use bioreactors on CHO cells N-glycome and produced monoclonal antibodies. She is now working in NIBRT as Bioanalytical Research Lead and is mainly interested in the development on new mass spectrometry based analytical approaches to ensure deeper and easier understanding of biomanufacturing process and biopharmaceuticals structural complexity.

Luigi Colombo

Luigi Colombo
 

Medical Technology Lab, Milano, Italy
 
Abstract  |  


Over 35 years in R&D in pharmaceutical companies, including Marion Merrell Dow, Hoechst Marion Roussell, Boehringer Ingelheim, Serono, and Merck. He co-founded Biosearch Italia, the first biotech company listed on the Italian Stock Exchange, which eventually went public on the Nasdaq and was acquired by Pfizer. Luigi currently works as an independent consultant. In addition to several collaborations in Pharma & Biotech, he is the CEO of Medical Technology Lab, an industrial holding company focused on seed investment in new technologies. Luigi graduated with honors in Chemistry and Pharmaceutical Technologies and served as an adjunct professor at the Università Statale di Milano (Italy).

Ettore Gilardoni

Ettore Gilardoni
 

Philochem AG, Zurich, Switzerland
 
Abstract  |  


Ettore Gilardoni studied Medicinal Chemistry and Pharmaceutics and got the PhD in Pharmaceutical Sciences in 2021 at the University of Milan. He joined Philochem in April 2021 as Research Scientist and since July 2022 he leads the mass spectrometry team. The team main activities vary from biodistribution of small organic molecules in biospecimens; biopharmaceuticals characterization, and proteomics application for target identification; host cell proteins characterization, and mechanism of action evaluation. He is author of more than 25 scientific papers and 4 patents.

Silvia Lorenzi

Silvia Lorenzi
 

Aptuit (Verona) S.r.l, an Evotec Company, Italy
Abstract  |  


Silvia Is a Senior Supervisor of Regulated Bioanalysis and Biomarker Immunoassay at Aptuit Verona. She has over 10 years in pharmaceutical development. She started as Associate Scientist in Merck R.B.M (Ivrea) in the Flow cytometry lab of the Clinical Biomarker unit, then she moved to Aptuit Verona where she worked for several years in the immunoassay lab conducting assays and ultrasensitive assays validation for Biomarkers quantification, PK, Immunophenotyping to support preclinical and clinical study. She is Study Director of validation studies and Responsible Scientist to support clinical phase studies. Silvia graduated with honors in Medical, Molecular and Cellular Biotechnology and holds a PhD in Immunology.

Nazim Mekaoui

Nazim Mekaoui
 

Novartis Pharma AG, Basel, Switzerland
 
Abstract  |  


Nazim is a seasoned scientist specialized in the characterization of synthetic peptides and biotechnological products. At Novartis, he contributes to the physico-chemical characterization of new biological entities throughout their drug development lifecycle. Before joining Novartis, he served as an analytical development manager at PolyPeptide Group, where he led drug substance characterization and method development efforts. Nazim holds a PhD in analytical sciences from the University of Lyon, mentored by Pr. Alain Berthod.

Francesca Morandini

Francesca Morandini
 

Aptuit (Verona) S.r.l, an Evotec Company, Italy
Abstract  |  


Master's degree in Agro-Industrial Biotechnology at University of Verona in 2004, PhD in Applied Biotechnology at University of Verona in 2009, Post doc experience at the National Research Council of Milano (IBBA Institute) from 2009 to 2011, Post doc experience at University Laboratory for Medical Research, Unit of Internal Medicine at the University of Verona from 2011 to 2017, Senior scientist at Aptuit from 2017 to 2022, Principal scientist at Aptuit from 2022 up to now.

Elena Piccoli

Elena Piccoli
 

Frontage Europe S.r.l., Nerviano, Italy
 
Abstract  |  


I'm responsible of the Biologics Bioassay Unit in Frontage Europe since January 2024. Before, I was Head of Analytical Biology group in Accelera srl..I have more than 8-years' experience in development and validation of Ligand Binding assays (LBA) for the analysis of biological therapeutics as support to preclinical and clinical studies. I graduated in Biotechnology (MSc) in 2007. Between 2007 and 2015 I worked as Research Fellow at IRCCS Istituto Neurologico Carlo Besta in Milan, mainly involved in biochemical and biological research on neurodegenerative dementias.

Barbara Pioselli

Barbara Pioselli
 

Chiesi Farmaceutici, Italy
 
Abstract  |  


Master's degree in Pharmaceutical Chemistry and Technology at University of Parma in 2001. PhD in Bio-chemical Sciences at University of Turin and University of Parma in 2004. Post doc experience at University of York (UK), Centre for Excellence in Mass Spectrometry from 2004 to 2007. Post doc experience at University of Parma from 2007 to 2009. Project Collaborator at Chiesi Farmaceutici R&D from 2009 to 2011. Senior scientist in Chiesi Farmaceutici R&D from 2011 and from 2013 Principal scientist and Biomolecules Structural Characterization Unit head in Global Research and Preclinical Development. From November 2023, student in First Level Master Degree in Scientific Communications at University of Parma.

Federico Riccardi Sirtori

Federico Riccardi Sirtori

Merck R.B.M., Ivrea, Italy; an affiliate of Merck KGaA, Darmstadt, Germany
Abstract  |  


He is a pharmaceutical chemist with strong competence in mass spectrometry with more than 20 years of experience in LC-MS and GC-MS techniques applied to small molecule and biopolymer (DNA, protein, antibodies). He holds a Laurea degree in organic chemistry and a Ph.D. in pharmaceutical chemistry from Milan University. Federico is currently working in Merck KGaA as Head of NBE-DMPK Innovative Bioanalytics. The department is focused on supporting NBE projects including the development and validation of new bioanalytical methods used to support preclinical studies (PK/TK). He was the author of more than 20 scientific publications.

Marzia Scalarone

Marzia Scalarone
 

Merck R.B.M., Ivrea, Italy; an affiliate of Merck KGaA, Darmstadt, Germany
Abstract  |  


Marzia is a Biologist graduated at the University of Turin. She joined Merck KGaA in 2001 as Researcher, then she held several positions, from Head of Lab in 2006 to QC Manager in 2022 within the Biological Quality Control Unit, where she currently works taking care of Quality Management System aspects.
The department develop, validate and perform crucial Analytical Methods to ensure the Biological Quality Control of the Merck biotechnological production process throughout every stage, from cell banks to market, for all commercial and development biologics of the Company.
Marzia has more than 20 years of experience in biological testing panel applied in a GMP-regulated environment to investigate the presence of viral contaminations in the production intermediates

Caterina Temporini

Caterina Temporini
 

Department of Drug Sciences, University of Pavia, Pavia, Italy
Abstract  |  


Master's degree in Pharmacy at University of Pavia in 2000. PhD in Pharmaceutical Chemistry and Technology at University of Pavia in 2005. Currently Associate Professor at the Pharmaceutical Analysis Laboratory, with experience on the development and the application of integrated analytical platforms for structural analysis and process optimization of biopharmaceuticals, including polypeptides, glycopeptides, and monoclonal antibodies from different sources (CHO cells, plants). The characterization of recombinant protein critical quality attributes is obtained by the most recent chromatographic stationary phases (HILIC, SEC, RP, IEX, Affinity) and instrumentations (HRMS). Within a multidisciplinary network, she is also working on the design, the synthesis and analytical characterization of neo-glycocojugate proteins as potential vaccines active against tuberculosis.

Registration

Registration is now closed!

Participants to the SSPA2024 can choose between three registration packages: an All Inclusive Registration (attendance in presence), a Basic Registration (attendance in presence) and a Virtual ticket (virtual meeting).

BASIC

  • Conference Tickets
  • Coffee breaks and meals
  • Abstract book
  • Social dinner
  •  

€ 365

SCI/EFMC members
(*Prices inclusive VAT, last acceptance: September 10, 2024)

€ 390

Not SCI/EFMC members
(*Prices inclusive VAT, last acceptance: September 10, 2024)

VIRTUAL TICKET

  • Conference Tickets
  • Three-day access to lectures
  • Abstract book
  •  
     

€ 150

SCI/EFMC members
(*Prices inclusive VAT, last acceptance: September 10th, 2024)

€ 170

Not SCI/EFMC members
(*Prices inclusive VAT, last acceptance: September 10th, 2024)

Registration policy and fees All registrations will be accepted until September 2, 2024. After this date, only basic and virtual will be accepted. Registration will close on September 10th, 2024.

GDPR The personal information we receive from participants will also be required after the School for statistical purposes and for the dispatch of information on relevant symposia/school in the future. If you do not wish your personal data to be published or distributed, please inform us when you register for the summer school.

Confirmation An e-mail confirming your registration will be sent to you upon reception of a pdf proof of bank trasnfer.

Cancellation must be submitted in writing to the SSPA Secretariat (secretariat@sspaweb.com). The policy regarding refund of the registration fee is as follows: For all inclusive registrations, cancellations received before August 29th, 2024 will not be charged by any fee but bank fee will be deducted. After August 29th, 2024 no refund will be made. For basic and virtual registrations, for cancellations received before September 10th, 2024 there will not be a cancellation charge (bank fee shall be deducted). After September 10th, 2024 no refund will be made.

Payment All payments should be made in Euro by bank transfer to:
Account holder: Società Chimica Italiana-SSPA
Bank address: DEUTSCHE BANK MILANO C 463, VIALE GIUSTINIANO 1
Iban Code: IT50N0310401603000000821734
Swift Code: DEUT IT M1463
Remittance have to be free of any bank charges to the organizers.

For extra-EU partecipants having troubles with payment by bank transfer a payment by credit card can be arranged upon request. To have it arranged please contact the SSPA2024 secretariat at secretariat@sspaweb.com

Proof of Payment must be submitted by e-mail (secretariat@sspaweb.com) at the time of registration. Please ensure that the name and company/University of each delegate is printed clearly to ensure that the payment will be correctly registered. The payment receipt and the attendance certificate will be sent to the participant by email at the completion of the School.

Insurance The Organizing Committee cannot accept any liability. Participants should make their own arrangements with respect to health and travel insurance.

Fellowships

The Divisione di Chimica Farmaceutica of the Società Chimica Italiana (Italian Chemical Society) grants 3 fellowships for the participation to SSPA2024. Fellowships, covering the registration fee and accommodation (twin room), are reserved to young members of the Divisione di Chimica Farmaceutica with no permanent position at their institution (PhD students, graduated fellows and post-doctoral fellows, RTDa, volunteers or young researchers from other public research bodies), born after 30 April 1989.

Applicants are invited to fill in the on line format and submit a brief description of their research project (max 1 page in A4 format including project title, font size 11 pt, max 4000 characters including spaces) and a supporting letter by the applicant’s mentor stating the candidate position, within 30th April 2024.
For further details click here (in Italian).

EXPIRED

Abstract submission

Italian and foreign Ph.D. students in the end phase of their Ph.D. project are kindly invited to orally present their work (20 minutes including discussion). Abstracts will be evaluated by the scientific committee prior acceptance. In the case the number of candidate presentations exceeds the number that can be accommodated in the program, a selection will be made on the basis of novelty, pertinence, and clarity. Abstracts for Ph.D. oral presentations must be submitted before June 16 2024, 12 pm, according to the template given here.

The PhD students whose abstract has been accepted must complete their registration within the early registration date to have their presentation confirmed.

 
EXPIRED
  • The abstract must be written in English and sent as e-mail attachment (word file)
  • Maximum length is 5 pages
  • Please edit carefully your abstract before submitting it and pay attention to reference style
  • A letter from the PhD mentor stating the PhD status of the presenter and compliance with the requirment of being an experienced PhD student (from the 3rd year onwards) should be submitted together with the abstract
  • We remind you that the presenting author must register before abstract submission

 
Committees

Scientific committee

  • Manuela Bartolini, Chair, Alma Mater Studiorum University of Bologna, IT
  • Giancarlo Aldini, Università degli Studi di Milano, IT
  • Massimo Breda, Aptuit (Verona) S.r.l, an Evotec Company, IT
  • Francesco Epifano, "G. d'Annunzio" University of Chieti-Pescara, IT
  • Alberto Massarotti, Università del Piemonte Orientale, IT
  • Federica Pellati, University of Modena and Reggio Emilia, IT
  • Edoardo Maria Sommella, University of Salerno, IT
  • Caterina Temporini, University of Pavia, IT
  •  

Local Organizing committee

  • Manuela Bartolini, Alma Mater Studiorum University of Bologna, IT
  • Serena Montanari, Alma Mater Studiorum University of Bologna, IT
  • Marina Naldi, Secretariat, Alma Mater Studiorum University of Bologna, IT
  •  
UNIBO QuVi
UNIBO FABIT
DCF
European Federation for Medicinal Chemistry and Chemical Biology

Golden Sponsor

Evotec

Contributor

Thermo Fisher Scientific

Previous editions

Drug development: bioanalytical aspects

Sept 21-23, 2022 (Rimini, IT)

Summer Course on Pharmaceutical Analysis

Sept 26-27, 2007 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 29-30, 2006 (Cogne, IT)

Summer Course on Pharmaceutical Analysis

Sept 29-30, 2005 (Rimini, IT)

Summer Course on Pharmaceutical Analysis

May 2, 2004 (Florence, IT)

Summer Course on Pharmaceutical Analysis

July 1-3, 2003 (Cogne, IT)

Summer Course on Pharmaceutical Analysis

June 10-13, 2002 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 3-5, 2001 (Lipari, IT)

Summer Course on Pharmaceutical Analysis

Sept 30-Oct 3, 2000 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 28-29, 1999 (Rome, IT)

Summer Course on Pharmaceutical Analysis

June 10-12, 1998 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

Sept 15-16, 1997 (Island of Elba, IT)

Summer Course on Pharmaceutical Analysis

June 12-14, 1996 (Island of Elba, IT)