EirGenix, Inc.
台湾のBiologics CDMOで、最も技術力のあるCDMOの1つで、且つ、バイオテクノロジー企業です。
その理由として例えば、以下の開発力から分かります。
biosimilar開発
trastuzumabは、中外製薬がオリジナルで、ハーセプチンという製品名です。Sandoz からの委託契約でtrastuzumabのbiosimilarをin houseで開発しています。2019/4現在、世界11カ国でPhase IIIが実施されています。Sandozとの契約では、Sandozは、中国、台湾を除く全てのグローバル市場において、EirGenixのEG12014の独占的な商業的権利を所得しました。2019/6には、EirGenixは、この契約の成功報酬として$500万を受け取っています。
現時点での「trastuzumab」のbiosimilar
Sandozは、以下のtrastuzumabのBiosimilar競争に参画しようとしている訳です。
編集履歴
2020/05/29 S2IND
Map
Service
以下に、CDMOとしての実力を知るために設備を中心に情報をまとめました。設備については知る機会がなかなかありませんが、EirGenixの設備について、360°で詳細を見ることができます(virtual tour)。
| Service | Summary |
| Cell Line Development | DNA to stable cell line cell line : CHO, NS0, PER.C6, E.coli, Pichia identified in 19 weeks serum-free medium screening platform |
| Cell Banking | cGMP production facilities for MCB and WCB |
| Process Development | 1) Upstream -1. process optimization, troubleshooting, media, feeding, process parameter – mammalian: flask, 2L, 5L, 50L SUB – microbial: 2L, 20L fermentor 2) Downstream -1. experience – mammalian: recombinant protein, fusion and mAb – microbial: inclusion body and soluble, pegylated protein, fusion and Plasmid DNA -2. equipment – LCS: AKTA PRIME, AKTA Pilot, AKTA Avant; column size: 1mL HiTrap to 14cmφBPG column – MF & UF system, UF/DF system,centrifuge of Disc and continuous, tank (316L SS), Homogenizer (Microfluidizer and APV) 3) Formulation -1. preformulation : Lyophilizer, Stability chamber, programmable controlled freezing and thawing system 4) Purity analysis – Three Agilent HPLC, one UPLC |
| Analytical/QC | – method development; method transfer; method qualification and validation; stability testing; Characterization : glycan analysis, glycan profile and ratio, monosaccharide, secondary or more analysis |
| – Item | – Potency/Activity : ELISA, Cell base assay – Impurity : Host cell DNA, Host cell protein, Protein A residue, Others – Biological safety : Endotoxin, Bioburden, Microbial enumeration – Analytical method qualification and validation : Specificity, Linearity & range, Accuracy and precision, LOD/LOQ – Glycan analysis : N and O-linked carbohydrates site and structure: HPLC/UPLC; N and O-linked glycan mapping and ratio : CE, LE/MS; N-glycan ratio : CE, LC/MS – Monosaccharide analysis : HPIC – Secondary and higher order structures: CD (Circular Dichroism), DSC (Differential Scanning Calorimetry), Fluorescence Spectrometer – Heterogeneity analysis : IEF/cIEF, CIX-HPLC |
| cGMP Manufacturing | Mammalian Certificates : 2005(T-FDA), 2014(T-FDA), 2017(foreign manufacturer) |
| – GMP facility (bioreactor), 360 virtual tour | 1st Floor : 10,000ft2 – Media preparation : 50L ~ 700L – 100L/500L SS – 50L/200L/1,000L SUB – Millipore POD and 3M CUNO filtration system – UF/DF (0.1~14 m2) – Column : 3mm ~ 10mmφ, 5cm~60cmφ – one purification room – one final purification room – Washer room and autoclave room – 2 x 2,000L SUB in northern part of Taiwan |
| – experience | Basically, clinical trial – Anti-IL20(CHO, PER.C6) – Anti-HSV (CHO) – Anti-TNFα(CHO) – Bio-similars (CHO |
| cGMP Manufacturing | Microbial Certificates : 2013(T-FDA), 2014(T-FDA), 2017(foreign manufacturer) |
| – GMP facility (bioreactor) | 5th Floor : 4,000ft2 – cell banking area (provide maximum 400 vials/batch) – inoculation suite – fermentation & harvest suite – – fermentor 20L/100L fermentor – – mixer tank 100L/200L/400L – – homogenizer 10L/hr, 100L/hr – purification suite – – UF/DF 0.5 ~ 5 m2 – – Centrifuge 10~100L semi-continuous – – Column 3mm ~ 6mmφ, 7cm ~ 45cm – bulk fill room – buffer preparation room – wash & autoclave room |
| – experience | – recombinant proteins – – soluble protein, Pichia – – complexes soluble protein, E.coli – – Pegylated proteins inclusion body, E.coli – Protein vaccines – – soluble protein, E.coli – Bio-similars – – Inclusion body, E.coli – Plasmid DNA (E.coli) |
| Special | Antibody Drug Conjugate (Four ADC commercial >60 in clinical in world situation) |
| – Strategic partner | Formosa Laboratories (58 chemists, 9 process patents) – high potency drug manufacturing – 2000L scale of APIs manufacturing – 50~1000L SS Reactor – 50~1000L chromatography column – Isolator (glove box) – 280L Falling Film Evaporator |
| – Linkers by partner | Linkers are key component in ADC EirGenix has partners with the leading linker development companies |
編集履歴 2020/05/2o S2IND