Biopharmaceutical GMP development and manufacturing services
Biopharmaceutical GMP development and manufacturing services
Your partner in biologics production
Diatheva is a Contract Development and Manufacturing Organization (CDMO) offering customized services for the production of microbial-based biopharmaceuticals. We offer a project management team focused on meeting the needs of our clients and their products on time and within budget. We work with you to achieve a robust scale-up process and an efficient cGMP solution.
Why us?
Experience
We have more than 15 years of experience in providing development and manufacturing of different GMP molecule formats including antibody fragments, enzyme and vaccines
Quality
We are GMP authorized for API production by EMA since 2006
Flexibility
Our production methods are designed to easily adapt to changes in the type and quantity of the product being manufactured
Cell line development
From cell to drug substance
DIATHEVA has extensive experience developing microbial cell lines beginning from the desired gene sequence to the stable cell line. We screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance. After selecting the best clones, we optimize production conditions to develop a high productivity cell line.
Cell line development
From cell to drug substance
DIATHEVA has extensive experience developing microbial cell lines beginning from the desired gene sequence to the stable cell line. We screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance. After selecting the best clones, we optimize production conditions to develop a high productivity cell line.
Process development
Development support to bring your biologic to clinical phase
We build a scalable process for your target product, in a time and cost-efficient manner.
Our process development service aims to increase your product yield and manufacture the best quality product. DIATHEVA can support you with our know-how on upstream, downstream and analytical methods development.
Process development
Development support to bring your biologic to clinical phase
We build a scalable process for your target product, in a time and cost-efficient manner.
Our process development service aims to increase your product yield and manufacture the best quality product. DIATHEVA can support you with our know-how on upstream, downstream and analytical methods development.
GMP Manufacturing
Bioproduction of drug substance for your preclinical and clinical studies
Our GMP Manufacturing team specializes in the microbial production of recombinant proteins, antibody fragments, enzymes and vaccines for preclinical and Phase I/II clinical trials. In our state-of-the-art GMP production facility (2200 m²) authorized by EMA we produce and release biological Active Pharmaceutical Ingredients (APIs). In our Quality Control (QC) laboratories, we carry out the analysis for the characterization and release of biologics including stability studies as per ICH Guidelines.
GMP Manufacturing
Bioproduction of drug substance for your preclinical and clinical studies
Our GMP Manufacturing team specializes in the microbial production of recombinant proteins, antibody fragments, enzymes and vaccines for preclinical and Phase I/II clinical trials. In our state-of-the-art GMP production facility (2200 m²) authorized by EMA we produce and release biological Active Pharmaceutical Ingredients (APIs). In our Quality Control (QC) laboratories, we carry out the analysis for the characterization and release of biologics including stability studies as per ICH Guidelines.
Regulatory support
We offer regulatory guidance to our clients to assist them through the regulatory application and review process
This service covers all the different regulatory stages during the drug development process: IND filings and amendments, the preparation of the Common Technical Document necessary for the registration of Medicines and the preparation of Chemistry, Manufacturing and Control (CMC) regulatory documents such as a Drug Master File (DMF) or Active Substance Master File (ASMF).
Regulatory support
We offer regulatory guidance to our clients to assist them through the regulatory application and review process
This service covers all the different regulatory stages during the drug development process: IND filings and amendments, the preparation of the Common Technical Document necessary for the registration of Medicines and the preparation of Chemistry, Manufacturing and Control (CMC) regulatory documents such as a Drug Master File (DMF) or Active Substance Master File (ASMF).