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• Protein Biotinylation Service • Custom Lysate Preparation Service • Immunogenicity Test Service > Anti-Drug Antibody (ADA) Evaluation Service > Neutralizing Antibody (NAb) Test Service • Anti-Drug Antibody (ADA) Evaluation Service • Neutralizing Antibody (NAb) Test Service • Thanksgiving Day Sale • Enzyme Target & Activator & Inhibitor Screening Service • GPCR Screening Service • Ion Channel Screening Service • Bio-layer Interferometry (BLI) Service • Electrophoretic Mobility Shift Assay (EMSA) Service • Transcription Factor Analysis > Electrophoretic Mobility Shift Assay (EMSA) Service > Chromatin Immunoprecipitation (ChIP) Assay Service > DNase I Footprinting Assay Service • Transporter Screening Service • Chromatin Immunoprecipitation (ChIP) Assay Service • Enzyme Activity Assay Service • DNase I Footprinting Assay Service • Co-Immunoprecipitation (Co-IP) • Surface plasmon resonance (SPR) Service • Pull Down Assay • Protein Mutant Library Construction • C1 Expression System • Protein Conjugation Service on Beads • Bacteria Expression • Yeast Expression • Mammalian Cell Expression • Insect Cell Expression • Animal-free Expression • Cell-free protein expression • Large-scale Protein Production • PEGylation Products and Services > Custom PEGylation Services > PEGylation Products • Basic Protein Characterization • Protein Labeling • Stable Cell Line Construction for Protein Expression • Protein Mutagenesis • Protein Interaction Analysis Services > Bio-layer Interferometry (BLI) Service > Co-Immunoprecipitation (Co-IP) > Surface plasmon resonance (SPR) Service > Pull Down Assay > Yeast Two-Hybrid Screening > Membrane-based Yeast Two-Hybrid Screening > CLIP-Seq Service > Protein Binding Site Mapping • Yeast Two-Hybrid Screening • Membrane-based Yeast Two-Hybrid Screening • Recombinant Protein or Antibody Production • Protein Expression Systems > Nicotiana tabacum Expression System > Bacterial Expression Systems(E. coli / Bacillus) > Yeast Expression Systems(P pastoris / S cerevisiae) > Baculovirus-insect Cell Expression Systems > Mammalian Expression Systems(CHO / 293) • PEGylation Services • Stable Cell Line Construction for Protein Expression • Process Development • cGMP Manufacturing • QC and QA • Bacterial Manufacturing • CLIP-Seq Service • Protein Binding Site Mapping • Quantum Dot Labeling • Protein Expression > Custom Lysate Preparation Service > C1 Expression System > Protein Co-expression Service in E. coli System > Protein Co-expression Service in Mammalian Cells > Trimeric Protein Production Service • Protein Co-expression Service in E. coli System • Protein Co-expression Service in Mammalian Cells • NovEgg Expression System • ADME/Tox Prediction • Pharmacophore Modeling • Screening and Profiling Services > Enzyme Target & Activator & Inhibitor Screening Service > GPCR Screening Service > Ion Channel Screening Service > Transporter Screening Service • Trimeric Protein Production Service • Incorporation of Bioorthogonal Handles > Incorporation of Unnatural Amino Acids > Incorporation of Unnatural Sugars > Direct Chemical Modification • Incorporation of Unnatural Amino Acids • Incorporation of Unnatural Sugars • Protein/peptide Crosslinking > Enzymatic Crosslinking Services > Photocrosslinking Services > Chemical Crosslinking Services • Enzymatic Crosslinking Services • Photocrosslinking Services • Chemical Crosslinking Services • Direct Chemical Modification • Protein-fluorophore Bioconjugation • Custom PEGylation Services • PEGylation Products • Target Protein Degradation - Proteolysis Targeting Chimera (PROTAC) Nicotiana tabacum Expression System

CONTACT US

Tel: 1-631-448-8149
Fax: 1-631-938-8127

cGMP Compliant Protein Production

Current Good Manufacturing Practice (cGMPs) is the main regulatory standard for ensuring human pharmaceutical quality, which is enforced by FDA. These practices provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Normally, cGMP manufacturing follows after process development procedure. Scientific staffs will transmit the process that is validated from the first Feasibility Study step to cGMP manufacturing staff and QC in a collaborative manner. The manufacturing process will not be changed when clinical trials initiate.

cGMP Compliant Protein Production

Profacgen is capable of providing cGMP compliant Protein Production service for our customers, which assures that protein drug products meet with the quality standards, and thus accelerate preclinical drug development process.

Our team has been dedicating to achieve our shared objectives by engineering our validated equipment and suites of full flexibility and high quality, and that ensures us a consistent and in-controlled operation.

Specifically, our cGMP compliant Protein Production service including - but not limited to - the following aspects:

  Cell banking services from cell line production to cryogenic storage.
  Fermentation batch/fed-batch and perfusion, up to 300 Liter
  Downstream purification technologies including homogenization, continuous centrifugation, filtration systems and chromatography purification systems.

 

Features:

  Qualified class 10,000 and 100,000 cleanrooms with class 100 biohoods.
  Production and purification of proteins expressed in mammalian and microbial systems.
  Dedicated upstream and downstream cleanroom suites.
  Independent QC and analytical testing laboratories.
  Reliable cell banking services.

 

 

Our state-of-the-art certificated facility is designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply. From the very beginning to our shared target, you can always trust us on our first-class facility and professional manufacturing capacity.

 

Please contact us for more details of our preclinical cGMP compliant protein production. Our experts will provide and help design an optimal solution for your project and trouble-shoot for you throughout the whole process.

CONTACT US
Email: info@profacgen.com
Tel: 1-631-448-8149
Fax: 1-631-938-8127
Address: 45-1 Ramsey Road, Shirley, NY 11967, USA