Production

GMP Approved Manufacturing Area

All single-use systems
Process development methods equipped with state-of-the-art technology
2 x 200 L production capacity (2 x 2000 L production capacity installation works are in progress)
50 L pilot scale production and purification capacity
400 L purification capacity
Technology transfer skills
Expert staff with great knowledge and experience

Turgut Pharmaceuticals Quality Control Laboratory performs all physicochemical, functional and microbiological tests for protein-based drugs,
It is a GMP certified Quality Control Laboratory,
Compliant with current legislative requirements,
Provides the highest quality in Quality Control services,
Uses the most advanced analytical techniques,
Method Development, Validation, Qualification and Continuous Improvement analyzes are carried out,
Performs Release/Stability/In-Process Tests,
Has an experienced QC team.

Totally single-use biotechnological product filling concept (Formulation=>Filling)
Nested syringe and vial filling in the same line (Groninger Flexpro)
The First Filling Line with Automatic Deliner
The First Fill & Capping Room Design with CFD (Computational Fluid Dynamics) Verification
The First mcHVLD IPC Container Closure Integrity Test Device
The First Visual Inspection Tables Compliant with European & Japanese Pharmacopoeia
The First Ionized Hydrogen Peroxide Fumigation System (TOMI SteraMist)
Installed Filling Line Capacity: 1ml Syringe: 3000 syringes/hour – 10 million syringes/year 6R Vials: 1400 vials/hour - 5 million vials/year 20R/30R Vials: 500 vials/hour - 2 million vials/year It is a modular system that can expand the filling volumes of syringes and vials with new molds.

Industrial cell line development technology
High quality industrial cell lines for 5 biosimilar products
Process development technology
Upstream and downstream production processes for high quality biosimilar mAbs
Fully equipped laboratory infrastructure capable of developing upstream and downstream processes for the production of high quality biosimilar mAbs
Professional staffs capable of developing upstream and downstream processes for the production of high quality biosimilar mAbs
Protein analysis technologies and methods
Physicochemical and functional characterization of reference products
Comparative analysis studies according to European Medicines Agency (EMA) and US Food and Drug Administration (FDA) requirements
200L large-scale processes of three different monoclonal antibodies
Clinical study and regulatory infrastructure for biological products
Phase I clinical report of a monoclonal antibody
Clinical record files (IMPD and IB) of two different monoclonal antibodies