MASTER CLASS MAGHREB PHARMA 2023

Wednesday, February 8, 2023

Track 2 - Biotechnology - Upgrade and quality

Dr. Ammar AZIOUNE

Director of the National Biotechnology Research Centre (C.R.Bt) Constantine

09h00 – 10h30

  • Topic: “Intelligent Cell Culture: A Powerful Tool for Pharmaceutical R&D
  • The current trend in pharmaceutical R&D is towards automation and increased data acquisition rates. The aim is to test a greater number of molecules and experimental contexts, but also to refine and cross-reference analyses. In this context, screening on cells in culture is increasingly favoured. However, they come up against a major problem: cells are complex objects which, on a classic culture substrate (petri dishes and microplates), often have a large phenotypic variability (size, shape, organisation of compartments, sensitivity to drugs, etc.). The classical solution is to increase the number of cells and parameters analysed and then to use sophisticated software to identify the cells and their components (segmentation) and to normalise the measurements.
    In contrast, cells in a tissue context have a very stereotyped shape and internal organisation, which is ensured by a well-defined distribution of adhesions of the cell to its neighbours on the one hand, and to the extracellular matrix on the other. Unfortunately, this stereotyped organisation is lost in classical culture and no numerical analysis can restore it.
    The aim of our presentation will be to introduce the audience to the field of cell culture, its advantages and disadvantages on the one hand, and on the other hand to propose new technologies called “Smart Cell Culture” which can ensure that each individual cell has a shape, size and stereotyped organisation very close to the tissue context. These technologies will enable us to obtain real “Organs on a Chip” for the research and development of new methods applied to cell therapy, regenerative medicine, toxicology and other biotechnological applications.
Dr Derouiche

Dr. Mohamed Tahar DEROUICHE

Head of Department at the Centre for Research in Pharmaceutical Sciences, University Hospital Research Teacher at the Department of Pharmacy of Constantine

10h45 – 12h15
  • Topic: “Contribution of pharmacodynamic studies in the development and promotion of biosimilar medicines.”
  • The gradual expiry of patents protecting biological medicines will inexorably favour the expansion of the biosimilars market.
    Establishing similarity between reference biologics (RBP) and biosimilars is a major regulatory and marketing challenge for biosimilar manufacturers.
    The aim of this workshop is to raise awareness of the role of comparative pharmacodynamic studies (mainly in vivo) in the development of biosimilar medicines (including quality control) and its technical and regulatory importance.
    Secondly, the workshop will address the interest of this type of study in the promotion of biosimilar medicines by providing health care practitioners and the general public with useful elements on the interchangeability of biosimilars with RBPs.
    The workshop will be an opportunity to discuss the feasibility and limitations of this type of study in the Algerian context.

Dr. Amin KADI

Cardiologist, CEO & Founder of Monitoring Force Group

Dr. Salah Eddine SAHRAOUI

President of the Algerian Society of Biotechnology and Medical Research

Prof. Amar TEBAIBIA

Head of the department of internal medicine, EPH El Biar
President of the Algerian society of obesity and metabolic diseases

13h30 – 15h30

  • Topic: “Biotechnology products: specificities and international clinical development”
  • Biotechnology-derived medicines can be either medicines produced from living organisms or their cellular components or simply conventional medicines, i.e. medicines produced by synthetic chemistry, but whose design requires the use of biotechnology, such as the identification of new cell targets.
    These pharmaceutical products share the different development stages of conventional medicines. It is almost impossible for them to reach the market without international clinical development, and they require a number of specificities and skills both at the level of programme design and in the investigation centres.
  • Topic: “Biosimilars: between economic interest and scientific challenges”
  • The abstract of the speech will be available soon
  • Topic: “Clinical expertise of biotechnology products”
  • The abstract of the speech will be available soon
Boufenissa

Dr. Mohamed Achraf BOUFENISSA

Head of the Quality Control Laboratory of the Department of Control of Biological Products at the Pasteur Institute of Algeria

16h00 – 17h00

  • Topic: “Analytical control of biological products”
  • Biologics, especially those derived from biotechnology, increasingly constitute a large part of the innovative therapies used for the treatment of various diseases.
    These biological products are characterised by their complexity, which has an impact on the validation of the analytical methods used for the quality control of these products, a specific validation approach has to be followed, in order to ensure reliable results according to the regulations in force.
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