Services
Services
What we manage:
Not trials,
but results.
CMO
/ CDMO
Management Service
Leveraging global CDMO networks, we provide systematic management from process development and tech transfer to clinical production and QC.
From candidate discovery batches to clinical sample production, we cover every stage.
Not just an outsourcing agency; we design and execute the entire journey from strategy to IND.
Fast CMC service from gene to cGMP Product

Service Portfolios Across NDC Boundaries
From ADCs to NDCs
Antibody Drug Conjugate (ADC)
Bispecific Antibody Drug Conjugate (bsADC)
Radionuclide Drug Conjugate (RDC)
Peptide Drug Conjugate (PDC)
Antibody Peptide Conjugate (APC)
Antibody Oligonucleotide Conjugate (AOC)
Peptide Oligonucleotide Conjugate (POC)
Degrader Antibody Conjugate (DAC)
Protein Protein Conjugate (PPC)
Antibody Glycan Conjugate (AGC)
Global CDMO Capacity (Production Modalities)
Small Molecules
Scalable from Early Clinical
to Commercial Production
Synthetic API
Gram ~ Multi-ton Scale
HPAPI (Highly Potent API, including Oncology)
Synthetic Peptides
Oral Dosage Forms (Tablets & Capsules)
Sterile Injectables
Global GMP-compliant facilities. Handling high-risk substances
(OEB 4–5).
Biologics
Integrated Production Platform
(End-to-End Bioprocessing)
Monoclonal Antibody (mAb)
Bispecific Antibody
Recombinant Protein
Biosimilar
Antibody-Drug Conjugate (ADC)
Cell Line Development (CLD)
& Beyond
Integrated GMP: Upstream, Downstream, and Fill-Finish. Proven inspection history with global agencies (FDA, EMA, PMDA).
Advanced Modalities
Next-Gen Biopharmaceutical
Production
Viral Vectors (AAV, Lentivirus)
mRNA / DNA Plasmid
Cell Therapy (CAR-T, NK Cell)
Gene Therapy
Clinical & Commercial GMP Production. Advanced Process & Sterile Management Systems.
Specialized Technologies
Oligonucleotide
Lipid Nanoparticle (LNP)
Vaccine Platform
(Protein / mRNA / Viral Vector)
Sterile Fill & Finish
Lyophilization
Discovery
Pharmacology Platform
Our Discovery Pharmacology Platform systematically analyzes efficacy, MOA, and risks through integrated in vitro, ex vivo, and early safety studies. Leveraging diverse assay platforms and expertise, we support efficient early evaluation and candidate selection.
DMPK/ADME Services
in vitro ADME
Permeability study by caco-2 cells, MDCK cells and vesicle
Protein binding study of plasma proteins, and tissue proteins, blood-plasma ratio
Metabolic stability and Met ID study by microsomes, S9, cell systems, tissue homogenate
DDI study including enzyme-related and transporter-related
PK Profile
Rodents/non-Rodents single-dose and multiple-dose PK study
Drug exposure-dose relationship study
Steady state and accumulation study
Absolute bioavailability and relative bioavailability study
DDI study
Food effect study
Distribution
Drug distribution study in rodents/non-rodents
Drug concentration-time profile in tissues
Drug exposure and accumulation in tissues
Plasma/tissue exposure ratio
Metabolism
Met ID study of plasma, tissues, urine, feces and bile in rodents/non-rodents
Metabolic pathway analysis
Major metabolites relative quantified by LC-MS (QTOF or Orbi MS)
Major metabolites quantified by radioisotope tracing method
Excretion
Urine, feces, bile excretion, cumulative excretion analysis in rodents/non-rodents
Mass balance (Relative quantification of drug prototypes and metabolites; isotopes for mass balance study)
Pharmacology Services
Rodent
Large
Animal
NHP
Oncology Models
Lymphoma, leukemia, lung cancer, breast cancer, ovarian cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, multiple myeloma, prostate cancer, melanoma, thyroid cancer, renal cancer, choriocarcinoma, glioblastoma, and pan-cancer indications, etc.
Inflammatory & Autoimmune Models
Sepsis, rheumatoid arthritis, osteoarthritis, COPD, ARDS, SLE, Crohn’s disease, ulcerative colitis, atopic dermatitis, skin aging models, etc.
Cardiovascular Models
Myocardial ischemia, infarction, and hypertrophy, heart failure, vein thrombosis, arterial thrombosis and cerebral ischemic stroke, etc.
Neurological Models (CNS, PNS)
Spinal Cord Injury, migraines, depression, ALS, AD, etc.
Metabolic Models
Diabetes and its complications gout, hyperuricemia, gastric ulcer, hyperlipidemia, obesity, osteoporosis, renal injury, etc.
Ophthalmological Models
Refractive diseases: Myopia, Presbyopia Anterior diseases: Conjunctivitis, Dry eye, Neurotrophic keratitis Visual neuron diseases: Retinitis pigmentosa, Glaucoma, Dry AMD Fundus vascular diseases: Wet AMD, Diabetic retinopathy Others: Uveitis, Cataract, Corneal defects
in vivo
imaging / testing
MRI, PET-CT, Micro-CT, X-Ray, SD-OCT, Slit Lamp, IVIS, Blood Flow, Muscle Strength, CMAP, NCV
Tissue/
Cellular Levels
LPT/LTD, H&E, Nissl, Myelin Staining, IHC, IF, TEM, FACS
DNA / RNA
Levels
PCR/qPCR, Exome-seq, RNA-seq, FISH, NanoString,
Transcriptome, SNP Genotyping, RNA Scope, ddPCR
Protein Levels
Western Blot, IHC, Phospho-Protein Array, Protein Array,
Luminex, Mass Spec, ELISA, SIMOA, Cytokine (MSD/Luminex/CBA), Fiber photometry, Microdialysis
Safety Assessment Services
(IND Package)
Leveraging top-tier GLP labs, we deliver systematic toxicology programs for IND filing, spanning strategy, operations, data management, and regulatory response.
Toxicology Service
General Toxicology
Rodents/Non-Rodents single-dose and multiple-dose toxicity study
Active systemic allergy test
Passive cutaneous anaphylaxis test
Guinea pig Buehler test
Local tolerance study
Safety Pharmacology
Central nervous system safety pharmacology study (FOB)
Cardiovascular system safety pharmacology study
Respiratory system safety pharmacology study
Digestive system safety pharmacology study
Reproductive Toxicology
Fertility and early embryonic development toxicity study in mice/rats (Segment I)
Embryo-fetal development toxicity study in mice/rats/rabbits(Segment II)
Pre- and postnatal development toxicity study in rats(Segment III)
Effects of Experiments on the Growth and Development of juvenile animals
Genetic Toxicology
Bacterial Reverse Mutation Assay(Ames)
Chromosomal aberration assay in vitro
Micronucleus assay in vitro
Micronucleus assay in rodents
In Vitro Mammalian Cell Gene Mutation Tests
Toxicokinetic And Immunogenicity
Toxicokinetic study
Immunogenicity assay
TK analysis method validation ADA analysis method validation
Analysis methods :LC/MS/MS, ELISA, MSD, qPCR, Luminex, FACS
Supported Modalities
Small molecules
Oligonucleotides
mAb
ADC
Peptides
Protein
BsAb
Cell & Gene Therapy
Successful Submissions
U.S., China, Australia, Netherlands, Germany, UK, France, Belgium, Korea and Singapore
GLP Sample Shipping
Experienced with Global Shipping
Both import and export
Tissues, slides, blood, serum, plasma, urine, feces, etc.
All laboratory species especially NHP
Accelerated timelines for CITES permits
Shipped NHP materials to U.S., Europe and Asia


Global Licensing Services &
Partnering
Leveraging global networks and deep R&D expertise, we provide a systematic licensing process—from strategy and partner sourcing to negotiation and communication.
Beyond simple mediation, Double Eight Partners redefines Licensing-Out as a process to build globally competitive assets.
Global Deal Strategy
01. Asset Positioning & Strategic Value Analysis
Reinterpreting assets from a global pharmaceutical perspective.
Indication & Market Analysis
IP & Exclusivity Analysis
Competitive Pipeline Benchmarking
Potential & Peak Sales Modeling
Structuring Clinical Differentiation
Comparable Deal Analysis
02. Licensing-Out Readiness Program
Non-Confidential Deck
CTD-based Data Indexing
Confidential Package
Integrated Q&A Master File
Virtual Data Room (VDR) Design
03. Global Partner Targeting Strategy
Global Pharma & Mid-cap Mapping
Regional vs. Global Deal Structuring
Step-by-step Outreach Planning
Conference-based Meeting Strategy (BIO, JPM, CPhI, etc.)
BD Contact Identification by Therapeutic Area
Global Deal Execution
& Negotiation
Deal Execution Management
NDA / CDA Management
Due Diligence Oversight
Structured VDR Q&A Response
Science-Regulatory Bridging
Deal Structuring Advisory (Upfront, Milestone, Royalty)
Term Sheet Review & Negotiation Support
Cross-border Communication
R&D–BD Narrative Alignment
Regulatory Context Alignment (FDA, EMA, NMPA)
Cultural & Negotiation Mediation
Global Time Zone-based Communication
Strategic Post-deal Support
Co-development Governance
Global CRO Management
CMC & Clinical Transition Management
Milestone & Alliance Management
Why Double Eight Partners
Double Eight Partners operates at the intersection of:
Scientific Expertise
Regulatory Insight
Global CRO Network
Strategic Business Development
Beyond a simple agency;
A Global Deal Architect integrating development, data, regulation, and commercialization.
services
What we manage:
Not trials,
but results.
We Manage
What Matters
Double Eight Partners는 신약 개발의 복잡한 비임상 과정을 전략 수립부터 IND 진입까지 통합 관리하는 전문 파트너입니다.
글로벌 시험 수행은 우리가 관리하고, 고객은 연구와 의사결정에 집중할 수 있도록 합니다.
About
Double Eight Partners
글로벌 비임상 매니지먼트 전문 파트너
Double Eight Partners는 글로벌 CRO 네트워크와 실무 중심 경험을 바탕으로 비임상 개발 전 과정을 관리합니다.
단순한 시험 의뢰 대행이 아닌, 개발 전략 수립부터 IND 진입까지 하나의 흐름으로 설계하고 실행합니다.
핵심 역량
1
글로벌 CRO 네트워크 기반 운영
2
핵심 데이터 중심 설계
3
일정과 비용의 최적화 및 균형 있는 관리
4
단일 창구 (Single Point of Contact) 기반 통합 관리
CMO
/ CDMO
MANAGEMENT SERVICE
Leveraging global CDMO networks, we provide systematic management from process development and tech transfer to clinical production and QC.
From candidate discovery batches to clinical sample production, we cover every stage.
Not just an outsourcing agency; we design and execute the entire journey from strategy to IND.
Fast CMC service from gene to cGMP Product

Service Portfolios Across NDC Boundaries
From ADCs to NDCs
Antibody Drug Conjugate (ADC)
Bispecific Antibody Drug Conjugate (bsADC)
Radionuclide Drug Conjugate (RDC)
Peptide Drug Conjugate (PDC)
Antibody Peptide Conjugate (APC)
Antibody Oligonucleotide Conjugate (AOC)
Peptide Oligonucleotide Conjugate (POC)
Degrader Antibody Conjugate (DAC)
Protein Protein Conjugate (PPC)
Antibody Glycan Conjugate (AGC)
Global CDMO Capacity (Production Modalities)
Small Molecules
Scalable from Early Clinical
to Commercial Production
Synthetic API
Gram ~ Multi-ton Scale
HPAPI (Highly Potent API, including Oncology)
Synthetic Peptides
Oral Dosage Forms (Tablets & Capsules)
Sterile Injectables
Global GMP-compliant facilities. Handling high-risk substances
(OEB 4–5).
Biologics
Integrated Production Platform
(End-to-End Bioprocessing)
Monoclonal Antibody (mAb)
Bispecific Antibody
Recombinant Protein
Biosimilar
Antibody-Drug Conjugate (ADC)
Cell Line Development (CLD)
& Beyond
Integrated GMP: Upstream, Downstream, and Fill-Finish. Proven inspection history with global agencies (FDA, EMA, PMDA).
Advanced Modalities
Next-Gen Biopharmaceutical
Production
Viral Vectors (AAV, Lentivirus)
mRNA / DNA Plasmid
Cell Therapy (CAR-T, NK Cell)
Gene Therapy
Clinical & Commercial GMP Production. Advanced Process & Sterile Management Systems.
Specialized Technologies
Oligonucleotide
Lipid Nanoparticle (LNP)
Vaccine Platform
(Protein / mRNA / Viral Vector)
Sterile Fill & Finish
Lyophilization
Discovery
Pharmacology Platform
Our Discovery Pharmacology Platform systematically analyzes efficacy, MOA, and risks through integrated in vitro, ex vivo, and early safety studies. Leveraging diverse assay platforms and expertise, we support efficient early evaluation and candidate selection.
DMPK/ADME
Services
in vitro ADME
Permeability study by caco-2 cells, MDCK cells and vesicle
Protein binding study of plasma proteins, and tissue proteins, blood-plasma ratio
Metabolic stability and Met ID study by microsomes, S9, cell systems, tissue homogenate
DDI study including enzyme-related and transporter-related
PK Profile
Rodents/non-Rodents single-dose and multiple-dose PK study
Drug exposure-dose relationship study
Steady state and accumulation study
Absolute bioavailability and relative bioavailability study
DDI study
Food effect study
Distribution
Drug distribution study in rodents/non-rodents
Drug concentration-time profile in tissues
Drug exposure and accumulation in tissues
Plasma/tissue exposure ratio
Metabolism
Met ID study of plasma, tissues, urine, feces and bile in rodents/non-rodents
Metabolic pathway analysis
Major metabolites relative quantified by LC-MS (QTOF or Orbi MS)
Major metabolites quantified by radioisotope tracing method
Excretion
Urine, feces, bile excretion, cumulative excretion analysis in rodents/non-rodents
Mass balance (Relative quantification of drug prototypes and metabolites; isotopes for mass balance study)
Pharmacology
Services
Rodent
Large
Animal
NHP
Oncology Models
Lymphoma, leukemia, lung cancer, breast cancer, ovarian cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, multiple myeloma, prostate cancer, melanoma, thyroid cancer, renal cancer, choriocarcinoma, glioblastoma, and pan-cancer indications, etc.
Inflammatory & Autoimmune Models
Sepsis, rheumatoid arthritis, osteoarthritis, COPD, ARDS, SLE, Crohn’s disease, ulcerative colitis, atopic dermatitis, skin aging models, etc.
Cardiovascular Models
Myocardial ischemia, infarction, and hypertrophy, heart failure, vein thrombosis, arterial thrombosis and cerebral ischemic stroke, etc.
Neurological Models (CNS, PNS)
Spinal Cord Injury, migraines, depression, ALS, AD, etc.
Metabolic Models
Diabetes and its complications gout, hyperuricemia, gastric ulcer, hyperlipidemia, obesity, osteoporosis, renal injury, etc.
Ophthalmological Models
Refractive diseases: Myopia, Presbyopia Anterior diseases: Conjunctivitis, Dry eye, Neurotrophic keratitis Visual neuron diseases: Retinitis pigmentosa, Glaucoma, Dry AMD Fundus vascular diseases: Wet AMD, Diabetic retinopathy Others: Uveitis, Cataract, Corneal defects
in vivo imaging / testing
MRI, PET-CT, Micro-CT, X-Ray, SD-OCT, Slit Lamp, IVIS, Blood Flow, Muscle Strength, CMAP, NCV
Tissue/ Cellular Levels
LPT/LTD, H&E, Nissl, Myelin Staining, IHC, IF, TEM, FACS
DNA / RNA
Levels
PCR/qPCR, Exome-seq, RNA-seq, FISH, NanoString,
Transcriptome, SNP Genotyping, RNA Scope, ddPCR
Protein Levels
Western Blot, IHC, Phospho-Protein Array, Protein Array,
Luminex, Mass Spec, ELISA, SIMOA, Cytokine (MSD/Luminex/CBA), Fiber photometry, Microdialysis
Safety Assessment
Services
(IND Package)
Leveraging top-tier GLP labs, we deliver systematic toxicology programs for IND filing, spanning strategy, operations, data management, and regulatory response.
Toxicology Service
General Toxicology
Rodents/Non-Rodents single-dose and multiple-dose toxicity study
Active systemic allergy test
Passive cutaneous anaphylaxis test
Guinea pig Buehler test
Local tolerance study
Safety Pharmacology
Central nervous system safety pharmacology study (FOB)
Cardiovascular system safety pharmacology study
Respiratory system safety pharmacology study
Digestive system safety pharmacology study
Reproductive Toxicology
Fertility and early embryonic development toxicity study in mice/rats (Segment I)
Embryo-fetal development toxicity study in mice/rats/rabbits(Segment II)
Pre- and postnatal development toxicity study in rats(Segment III)
Effects of Experiments on the Growth and Development of juvenile animals
Genetic Toxicology
Bacterial Reverse Mutation Assay(Ames)
Chromosomal aberration assay in vitro
Micronucleus assay in vitro
Micronucleus assay in rodents
In Vitro Mammalian Cell Gene Mutation Tests
Toxicokinetic And Immunogenicity
Toxicokinetic study
Immunogenicity assay
TK analysis method validation ADA analysis method validation
Analysis methods :LC/MS/MS, ELISA, MSD, qPCR, Luminex, FACS
Supported Modalities
Small molecules
Oligonucleotides
mAb
ADC
Peptides
Protein
BsAb
Cell & Gene Therapy
Successful Submissions
U.S., China, Australia, Netherlands, Germany, UK, France, Belgium, Korea and Singapore
GLP Sample Shipping
Experienced with Global Shipping
Both import and export
Tissues, slides, blood, serum, plasma, urine, feces, etc.
All laboratory species especially NHP
Accelerated timelines for CITES permits
Shipped NHP materials to U.S., Europe and Asia


Global
Licensing Services
& Partnering
Leveraging global networks and deep R&D expertise, we provide a systematic licensing process—from strategy and partner sourcing to negotiation and communication.
Beyond simple mediation, Double Eight Partners redefines Licensing-Out as a process to build globally competitive assets.
Global Deal Strategy
01. Asset Positioning & Strategic Value Analysis
Reinterpreting assets from a global pharmaceutical perspective.
Indication & Market Analysis
IP & Exclusivity Analysis
Competitive Pipeline Benchmarking
Potential & Peak Sales Modeling
Structuring Clinical Differentiation
Comparable Deal Analysis
02. Licensing-Out Readiness Program
Non-Confidential Deck
CTD-based Data Indexing
Confidential Package
Integrated Q&A Master File
Virtual Data Room (VDR) Design
03. Global Partner Targeting Strategy
Global Pharma & Mid-cap Mapping
Regional vs. Global Deal Structuring
Step-by-step Outreach Planning
Conference-based Meeting Strategy (BIO, JPM, CPhI, etc.)
BD Contact Identification by Therapeutic Area
Global Deal Execution
& Negotiation
Deal Execution Management
NDA / CDA Management
Due Diligence Oversight
Structured VDR Q&A Response
Science-Regulatory Bridging
Deal Structuring Advisory (Upfront, Milestone, Royalty)
Term Sheet Review & Negotiation Support
Cross-border Communication
R&D–BD Narrative Alignment
Regulatory Context Alignment (FDA, EMA, NMPA)
Cultural & Negotiation Mediation
Global Time Zone-based Communication
Strategic Post-deal Support
Co-development Governance
Global CRO Management
CMC & Clinical Transition Management
Milestone & Alliance Management
Why
Double Eight Partners
Double Eight Partners operates at the intersection of:
Scientific Expertise
Regulatory Insight
Global CRO Network
Strategic Business Development
Beyond a simple agency;
A Global Deal Architect integrating development, data, regulation, and commercialization.
Double Eight Partners
CEO : Jenny Yang
Business Number : 848-81-03975
TEL : +82) 31-8065-5321
FAX : +82) 31-8065-5320
Email : info@88ptns.com
Address : B1104, 11F, Complex-dong, Heungdeok IT Valley, 13, Heungdeok 1-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
Double Eight Partners
CEO : Jenny Yang
Address : B1104, 11F, Complex-dong, Heungdeok IT Valley, 13, Heungdeok 1-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
Business Number : 848-81-03975
Tel. : 031-8065-5321
Fax. : 031-8065-5320
Email : info@88ptns.com
Double Eight Partners
CEO : Jenny Yang
Business Number : 848-81-03975
Tel. : 031-8065-5321
Fax. : 031-8065-5320
Email : info@88ptns.com
Address : B1104, 11F, Complex-dong, Heungdeok IT Valley, 13, Heungdeok 1-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea