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Update your choices | BU : GMP BioManufacturing | Country : USA

GMP Contract Manufacturing

Eurogentec is a GMP accredited manufacturer of parenteral biologics. We produce clinical trial material for all major markets and produce according to FDA and EMA requirements.
As experts in the manufacturing of biologics from bacterial and yeast sources, we offer significant know-how in high cell density fermentation, purification by refolding of inclusion bodies, isolation of periplasmic or extracellular secreted proteins, the purification of intracellular soluble proteins as well as plasmid DNA production.

Benefits

FDA Inspected and Approved for Commercial Manufacturing


Comprehensive GMP Experience

GMP accredited since 1994
> 100 custom GMP processes developed
> 500 GMP batches released
Manufacturing according to FDA 21 CFR Part 210 & 211, EU 2003/94/EC and Eudralex Vol 4

Unique Manufacturing Platforms

Strain specific high density fed-batch fermentation methods
Continuous / non-batch based purification methods, highly scaleable
Off-patent Pichia pastoris cell line development
Pichia O-glycosylation reduction technology
Plasmid manufacturing to 200 g scale

Host System Experience

Manufacturing with all the important microbial strains:
E. coli
P. pastoris
H. polymorpha
S. cerevisiae
Biosafety level 2 micro-organisms that are non-sporulating

Multi-Product Manufacturing Facility

3 GMP Fermentation suites (up to 500 L)
2 GMP Purification suites
1 GMP Sterile Filtration suite

Experience in all Clinical Phases

 

Manufacturing for Phase I, II, III and Commercial
Process development : USP, DSP, QC...
QC Qualification and Validation Plan
Process Characterization
Process Validation
In-house QP Release of DS and DP

Product Experience

 

Plasmid DNA Vaccines
Recombinant Proteins
PEGylated Proteins
Peptide-Protein Conjugates
Biosafety Level 2 Microbes

Comprehensive Service Offering

 

Cell Line Development
GMP Cell Banking
USP, DSP and QC Development
Stress Stability Studies
Preformulation Development
API Manufacturing
Fill & Finish, Packaging, Labeling
Tox Batch Manufacturing
GMP Clinical Trial Manufacturing
Process Characterization & Validation
GMP Commercial Manufacturing
ICH Stability Studies

Technical Expertise

 

Fermentation Development
Pichia O-glycosylation reduction
Purification Development
In-house Development of QC Tests
Formulation by Design of Experiment Based Stress Stability Studies
Scale-down Model Validation
Statistical Approach to Process Analysis and Specification Setting

Comprehensive Expression Experience

 

Refolding of Inclusion Bodies
Periplasmic Expression
Soluble Cytoplasmic Expression
Extracellular Secretion

To request a proposal, please click here.


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