Biotechnology Unit

The Biotechnology unit implements many scientific and practical measures to ensure the quality, safety and efficacy of the biotechnological products, including:

  •         Erythropoietin.
  •         Granocyte colony stimulating factor (GCSF).
  •         Insulins.
  •         Growth hormones.
  •         Streptokinase.
  •         Monoclonal antibodies.
  •         Hormones.
  •         R blood derivatives.

These are achieved by a technical team trained on the techniques of analysis and evaluation, and are able to perform the following tasks:

First: Practical tasks:

Conducting identity, potency and purity tests for biotechnological products that are received from (registration, lot release and post-marketing surveillance) departments using the following laboratory techniques:

  •         SDS-PAGE.
  •         Western blot.
  •         ELISA.
  •         Invivo/invitro bioassay.
  •         Double Radial Immune-Diffusion (DRID).
  •         Clotting lyis and Clot formation.
  •         Cell banking and preservation for several types of cell lines.

Second: Technical tasks:

     Evaluation of all documents concerning biotechnological products for the following departments:

Registration department:

Review the quality module of the registration files for biotechnological products, whether innovative or biosimilar, according to the international guidelines and issuing the technical evaluation report.

Lot Release department:

Review all documents and certificates for all biotechnological products for release.

     The lab also implements the quality system throughout all the performed tasks.

Third: GMP Inspection:

The lab inspects local and international biotechnological factories in cooperation with the Central Administration of Pharmaceutical Affairs and ensures that the rules of good manufacturing practice are well implemented.

Our Creative Team

Ph. Asmaa Ahmed

Technical Manager

Ph. Yasmin Maher

Quality Manager

Ph. Hadeer Mohamed

QC Specialist

Ph. Amany Elshahawy

QC Specialist

Ph. Dalia Samir

QC Specialist and Safety monitor & evaluator

Ph. Hager Mohamed

QC Specialist

Ph. Eman Mohamed

QC Specialist

Ph. Khadija Fathy

QC Specialist

Ph. Islam Tarek

QC Specialist

Ph. Amna Mohamed

QC Specialist

Ph. Elshaimaa Gamal

QC Specialist

Close Menu