Services
우리가 관리하는 것은
'시험'이 아니라
'결과'입니다
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
글로벌 CDMO 네트워크와의 협력을 기반으로 공정 개발, 기술 이전, 임상용 물질 생산 및 품질 관리까지 전 과정에 걸친 체계적인 CDMO 매니지먼트를 제공합니다.
후보물질을 찾기 위한 소량 생산부터 임상시료 생산까지 전 분야 의뢰 가능
단순한 시험 의뢰 대행이 아닌, 개발 전략 수립부터 IND 진입까지 하나의 흐름으로 설계하고 실행합니다.
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)
글로벌 CDMO 생산역량 (Production Modalities)
저분자 의약품
Small Molecules
초기 임상용 생산부터
상업화 규모까지 확장가능
합성 원료의약품(API)
Gram ~ Multi-ton Scale
고활성 원료 의약품 (HPAPI, 항암제 포함)
합성펩타이드
경구제형(정제, 캡슐)
무균 주사제(Sterile Injectable)
글로벌 GMP 기준의 생산시설 운영,
OEB 4~5 등급 고위험 물질 대응 가능
바이오 의약품
Biologics
통합 바이오 생산 플랫폼
(End-to-End Bioprocessing)
단일클론항체(mAb)
이중항체(Bispecific Antibody)
재조합 단백질(Recombinant Protein)
바이오시밀러(Biosimilar)
항체-약물 접합체(ADC)
세포주 개발
(Cell Line Development)부터
Upstream / Downstream / Fill-Finish까지
통합 GMP 대응 FDA, EMA, PMDA 등 글로벌
규제기관 실사 경험 보유
첨단 치료제
Advanced Modalities
차세대 바이오 의약품 생산 역량
Viral Vector (AAV, Letivirus)
mRNA / DNA Plasmid
세포치료제 (CAR-T, NK Cell)
유전자치료제(Gene Therapy)
임상용 및 상업용 GMP 등급 생산 가능
고난도 공정 및 무균 관리 시스템 구축
특수 기술 플랫폼
Specialized Technologies
Oligonucleotide
Lipid NanoPparticle (LNP)
Vaccine Platform
(Protein / mRNA / Viral Vector)
무균 충전(Fill & Finish)
동결건조(Lyophilization)
Discovery
Pharmacology Platform
더블에이트파트너스의 Discovery Pharmacology Platform은 in vitro, ex vivo 및 초기 안정성 평가를 통합한 연구 접근 방식을 기반으로 후보물질의 효능, 작용기전 및 잠재적 위험요소를 체계적으로 분석합니다. 다양한 assay 플랫폼과 서비스 경험을 기반으로 효율적인 초기 평가와 후보물질 선정을 지원합니다.
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,colorec tal 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)
글로벌 Top-tier GLP 시험기관들과의 협력을 기반으로 IND 제출을 위한 독성시험 전략 수립 부터 시험 운영, 데이터 관리 및 규제 대응까지 체계적인 독성 평가 프로그램을 제공합니다.
Toxicology Service
General Toxicology
pRodents/non-Rodents single-dose and multiple-dose toxicity study
Active systemic allergy test
Passive cutaneous allergy 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
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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
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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
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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
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