Introduzione
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
Biologics manufacturing is a complex procedure, and it takes time and effort.
While classical therapeutic small molecules are made by well-known organic or chemical synthesis with few critical steps, biologics (and biosimilars) are produced by living cells in a very complex process with several critical phases.
Moreover, the biological molecule itself is complex. Unlike small molecular drugs, whose structure is homogeneous and well characterized, biologics (and biosimilars) are less easily characterized because of their intrinsic heterogeneous nature (several physiological isoforms).
Precisely because biologics are produced in living cells, it is almost impossible to guarantee that each batch is identical to the previous one. In any case, manufacturers are required to have as much control over the process as possible to identify and manage unexpected variations which may affect product quality, efficacy, and safety.
Taking into account the specific nature of biologics, based on regulatory guidance and case studies, this course aims to explain the regulatory considerations for biologics and biosimilars manufacturing to obtain clinical trials and marketing authorizations in Europe. Among the vast world of biologics, we will focus on monoclonal antibodies, vaccines, and insulins.
- Introduction and history of biologics and biosimilars
- Current regulatory landscape in Europe regarding biologics manufacturing and analytical method
- An overview of the challenges related to biologics development, manufacturing and characterization: insights into reconciling regulatory requirements and technical difficulties in the production process and analytical methods
- Common regulatory findings: case studies discussion to avoid non-conformities
- EU vs US regulatory differences and how these can impact production and control
- What do Authorities expect in case of manufacturing variations? Activities and documentation to be performed and presented by the Production, Quality Control, Quality Assurance and Chemistry, Manufacturing and Control (CMC) departments
- Definition of biosimilarity and biocomparability: product-specific biosimilar guidelines to keep in mind
- Characterization of biosimilars with respect to the originator molecules: the great initial analytical effort to get a smoother clinical commitment
- An overview of the registration pathway for biosimilars aimed at non regulatory personnel
Personnel working in and with CMC, manufacturing/analytical method development and validation areas, who are interested in knowing regulatory requirements for biologics and discussing how to meet them.
Participant experience
Ideally 1-2 years experience in biologics manufacturing and characterization, in order to enrich the discussion and exchange during our training.
The workshop is intended to be a ‘two-way’ learning and discussion experience; questions and subsequent discussion are welcome at any time during the workshop.
The presentation will be followed by questions and answers throughout the training.
Docente/i
Fernanda Manhães
Fernanda has a PharmD degree, a Master in Health Economics and Pharmacoeconomics and a course of Leadership in Innovation from the Massachusetts Institute of Technology (MIT). With her more than 10 years of experience in Regulatory Affairs, she has assisted many pharmaceutical companies in all stages of growth, from start-ups to established multinationals, with the global regulatory strategy to filings in Europe, US and Brazil. Her experience ranges from clinical trials to marketing authorizations and post-authorizations including chemicals, biologics, and medical devices/combination products.
Online Training – 2 modules
Module 1 | 21 October 2024 from 02:00 pm to 06:00 pm CET
Module 2 | 28 October 2024 from 02:00 pm to 06:00 pm CET
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 905,00* (until 30 September 2024)
Ordinary: € 1095,00*
Freelance – Academy – Public Administration**: € 640,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.