We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
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