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

© 2026 Double Eight Partners. All rights reserved.

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

© 2026 Double Eight Partners. All rights reserved.
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

© 2026 Double Eight Partners. All rights reserved.