Analytical Methods

A3P Switzerland Forum

Place

LAUSANNE

Date

September 28, 2021

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Format

Conferences, round table, exhibition

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The validation, the implementation and the transfer of analytical methods are strategic steps for the development, production, product release and monitoring of production processes.
The validation or transfer of analytical procedures, required by the various regulations (ICH, EMA, FDA, PMDA…), provide proven track records on data reliability generated to characterize the batches produced and the manufacturing process, and guarantee that these procedures are fit for purpose.
However, the recent USP <1220> and future ICHQ2(R2) and ICHQ14 texts raise the importance of the other stages in the life cycle of an analytical method: the acquisition of a thorough knowledge of the analytical procedure during development (including the study of robustness), a real control of the reliability of the results (including the notions of measurement uncertainty) and the monitoring of the analytical procedures after validation are key to guarantee the reliability of the results generated over time.

This global management of the life cycle of an analytical method, with a focus on certain important steps and feedbacks, will be discussed during our next forum dedicated to analytical methods.

 

 

Official language of the conferences: English
No simultaneous translation 

Tuesday, September 28, 2021

Welcome of the participants
08:45
Introduction
Vincent Griffoul, A3P Switzerland President
09:30
Analytical Procedure Life Cycle Management at a glance
Gérald De Fontenay, CEBIPHAR et GIC A3P Méthodes Analytiques
09:45
Biologics characterisation, from R&D to QC release
Luc-Alain Savoy – SGS
Biologics are very large and complex structures manufactured in living cells or organisms. Their in depth characterisation is essential for regulatory acceptance but particularly difficult because they are composed of several molecular entities more commonly referred to variants. A review of the methods used for the physico-chemical characterisation will be presented and segregated in 2 categories: the methods used to increase the knowledge and understanding of the product and it’s structure/function relationship and, derived from this group, the methods used for batch release and stability assessment.
10 :15
Coffee break & visit of the exhibition
10:45
The robustness of analytical methods, when? how? why?
Jean-Marc Roussel
Since the emergence of the concept of "Quality by Design" in physico-chemical analysis and the announcement of the future ICH Q14 "Analytical Procedure Development" guide, there has been a renewed interest from laboratories in robustness studies of analytical methods. We propose to review the tools and methodologies applicable to this task, from reflection on the scope of the study to proposals for the interpretation of the operating factors influence on the experimental measurement and to demonstrate their interest in the context of life cycle management of analytical methods.
11:30
Pharmaceutical analytics in a fully outsourced configuration
Andreas Layer, DEBIOPHARM
The concept of “virtual” pharmaceutical companies exists now since a few decades. It designates, in a simplified definition, those pharmaceutical companies with no, or limited, internal laboratory capabilities, particularly for CMC, but also for research. For their activities, these companies rely on CMO’s and CRO’s and other external partners. Debiopharm International SA can be described as a mixed company, having internal capabilities for some focused activities, but others being fully outsourced. Today’s presentation will focus on the particularities of pharmaceuticals analytics in a fully outsourced environment: origin of the methods, status of the methods, transfer of the methods, validation of the methods, regulatory and quality management aspects. Outsourcing of analytics has its advantages, but also drawbacks, which will be discussed in the context of some case studies.
12:00
Lunch
12:30
Continued Method Verification: advanced monitoring of method performance and beyond
Jean-François Dierick & Phu Nguyen, GSK
In line with regulatory expectations on analytical procedure lifecycle and in response to business needs, the continued method verification (CMV) process continually monitors and evaluates the performance of analytical methods. When covering extensively method parameters and using the appropriate statistical tools, CMV provides increased proactiveness in detecting and anticipating potential testing issues. Nevertheless, the growing body of data secured by CMV also offers a ready-to-use dataset in the context of investigation or for big-data type analysis. A blue-sky vision of the future of analytical method lifecycle management that lies beyond the current CMV process will also be shared. This vision relies on CMV-type systems and integrates the principles of AQbD. It is also catalyzed by the potentialities offered by digitalization to integrate several sources and types of data and perform sophisticated retrospective and prospective analysis.
14:00
Analytical method obsolescence: challenge and opportunities of transition to new methods
Carine Dortu, UCB
14:30
Analytical methods in the context of Process Monitoring
Cédric Paulou, TAKEDA
Continued Process Verification (CPV) is a key element of current control strategies ensuring product- and process consistency. While Quality by Design (QbD) concepts have been integrated to support this goal for the past decade, analytical methods did not always benefit of the same impulsion. Bridging this gap promises to improve data interpretation and knowledge acquisition, as analytics and process are intrinsically linked. This presentation will review some of the challenges, benefits, and interconnexions between process and method monitoring programs, with an outlook on perspectives in the field.
15:00
Coffee break and visit of the exhibition
15:30
Total-error-approach-based analytical method validation
Ricardo Diaz, GALDERMA
Detailed methodology to determine the validation status of an analytical method by using the accuracy profile. The approach simultaneously assesses both systematic and random analytical errors to calculate the total method error. The latter is then compared to scientifically sounded acceptance criteria to conclude about the validity of the method. Similar approaches are discussed to deal with analytical method transfer validation and methods comparability
16:00
Round table – Panel discussion & Q&A session
Lead by Isabelle Weissinger, WUXI STA PHARMACEUTICAL
16:30
Conclusion and end of the event
17:30

Gérald DE FONTENAY / Cebiphar 

CarineDORTU/ UCB

Jean-Marc ROUSSEL

Jean-François DIERICK / GSK

Andreas LAYER / Debiopharm

Luc-Alain SAVOY/ SGS

Ricardo DIAZ

Phu NGUYEN LE MINH/ GSK

Isabelle WEISSINGER-UNTERSEE / Wuxi

If you want to book a booth, please fill-in the online form

Exhibition formular

Map of the exhibition

Plan expo forum methodes analytiques
CompanyBooth Nr CompanyBooth Nr
15
SOFAST26
ELLAB3FILAB7
NUVISAN4ICARE8

Services included with the Table Top stand

  • A dedicated exhibition area (2m deep x 3m wide) on which you can install your products and communication tools: umbrella stand, roll-up, display, product, … A basic equipment including a 180 x 80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker.
  • Breaks and meals indicated in the program.
  • Unlimited Wifi.
  • A badge that allows you free access to the entire technical and scientific programm.
  • The attendees list

Registration Form

A3P Switzerland Forum 

Registration fee : 500€ excl. VAT + compulsory A3P membership*

(* Membership fee depending on the country where your company is based: 220€ / 280 CHF / 5000 DA / 2000 DHS. Click here for more information)

Contact

Depending on your requirements and preferences, you can contact Nina CHATRE :

Phone : +33 7 58 68 94 49
Email : nchatre@a3pservices.com
Postal Address: A3P, 30 rue Pré-Gaudry – Lyon 69007 (France)

On-Site: Aquatis Hotel, Route de Berne 148, CH-1010 Lausanne (Switzerland)

Fees

If you’re already a member of the A3P association: 500€ (excl. VAT)

If you’re not a member of the A3P association: 720€ (excl. VAT).  This price includes: registration fees for the event (500€), as well as the compulsory membership to the association valid for 1 year (220€ excl. VAT*)

(*  Excluding A3P Delegations For more information about the A3P membership, please click here). 

 Health protocole

Following the announcement of the Swiss Federal Council, as of September 13th, a COVID certificate is required to access our events.
The COVID certificate is a way of documenting that you have been vaccinated for COVID-19, have had the disease or have a negative test result.
You can request the COVID certificate on paper or as a PDF document with a QR code. In electronic form, it is available in the COVID Certificate application
For more information about the COVID Certificate, please consult the website of the Federal Office of Public Health FOPH.

If you are a foreigner in Switzerland, there are two possible cases:
– You are double-vaccinated: in this case, fill in the form for entering Switzerland via the FOPH website: https://swissplf.admin.ch/formular
– You are not double-vaccinated: you must present a PCR test (see explanations here).

Access

Hotel reservation

Aquatis Hotel
Route de Berne 148, CH-1010 Lausanne (Switzerland)
Tél. : +41 (0) 21 654 24 24
Email : info@aquatis-hotel.ch