development and manufacturing

Our support for development and manufacturing

As a competent and efficient partner for the development, manufacturing, and approval of innovative cell therapies and ATMPs, we offer your biotech or pharmaceutical company success oriented CDMO services:

  • Support in the development and formulation of your ATMP
  • Transfer and validation of existing methods or development of new analytical methods for the quality control of your product in terms of patient safety, purity, identity, and efficacy
  • Transfer and scale-up of processes into GMP-compliant, industrially usable manufacturing processes in compliance with all relevant regulatory requirements
  • Generation of all necessary GMP documents
  • Manufacturing of small and larger batches for clinical trials as well as establishing routine production processes for your product
  • Quality control and release procedures for your product 
  • Support of your team.

 

Quality control at its highest level

Various quality control methods for cell therapies and ATMPs can be performed in-house in our quality control laboratories:

  • cell characterization and phenotype determination
  • cell count/cell viability assays
  • automated RNA isolation and cDNA synthesis, RT-qPCR
  • sterile testing using isolators and BACT/ALERT® instruments
  • standardized mycoplasma detection
  • endotoxin testing

For serological tests we use a central and established contract laboratory. If your project requires additional services such as chemical analysis, rheological or mechanical measurements, our long-standing and specialized partners will provide the analytics tailored to your requirements.

Your contact person for our CDMO services

Do you have questions about our CDMO services, or would you like to learn more about our portfolio? Our CDMO experts are at your disposal. We look forward to talking with you.

Your contact person for our CDMO services

Dr. Christian Ebel
Head of Business Development
TETEC AG
Aspenhaustraße 18
72770 Reutlingen
Germany