Hanmi Bio Plant Complex

Established in 2007, Hanmi Bio Plant has been fully devoted to manufacturing biological medicine with highest quality.

Hanmi Bio Plant

Bio Plant Complex

Established in 2007, Hanmi Bio Plant has been fully devoted to manufacturing biological medicine with highest quality.
We are experts in manufacturing and development of recombinant protein products based on microbial fermentation and biochemical conjugation reaction processes. Our current pipeline includes more than 10 biologics and medical device products in various clinical phases and commercialization.
In 2008, Hanmi Bio Plant received KGMP certification as well as Hyaluronate product approval. In 2011, its facility and Hyaluronate-based product have gained ISO 9001, ISO 13485 and Directive 93/42/EEC certification from SGS. In 2018, our product obtained US FDA PMA approval as a Class 3 medical device product.

Hanmi Bio Plant Complex – Best-Fit CMO/CDMO Facility

Hanmi has two GMP production facilities with on-site R&D resources

  • 2007 Established and KGMP accredited
  • 2018 US FDA PMA approval of SynojoyntTM (Hyaluronate Sodium Injection, Medical Device for Osteoarthritis Joint Pain)
  • 2020 US FDA BLA approval (Rolontis®) pending FEI No. 3009350213

Clinical to Commercial Scale Manufacturing and Development

  • We are capable of manufacturing recombinant proteins, plasmid DNA, mRNA, including template DNA production, in-vitro transcription to purification in flexible scales
    • E.coli fermentors: 300 L ~ 10,000 L x2 (largest in Korea)
    • Biochemical reactors: flexible up to 500 L or 7,500 L
    • Purification: flexible up to 3 kg / batch by Centrifugation, Chromatography, UF/DF TFF
  • Commercial-ready, state-of-the-art, CGMP manufacturing facilities
  • Experience in HA inspection with US FDA-standard Quality System
  • Expanded manufacturing capacity enabling dedicated production facility
  • On-site R&D resources available (Process Dev, Analytical Dev and CMC RA)
  • Reliable/quality raw materials sourcing by Hanmi Fine Chemical Co.

Production Building 1 & 2

Total Area
49,000 m2 (527,000 ft2)
Manufacturing Areaa
40,000 m2 (431,000 ft2)
TQA/QC Area
4,340 m2 (47,000 ft2)
Employees
Over 500 (170 in Production, 150 in QC/QA,70 in Development, 80 in Engineering)
Fermentation (E.coli)
10,000L Bioreactor x 2
Biochemical Reaction(in-vitro transcription
500L, 7500 L reactors
Purification
Up to 3kg per batch by Centrifugation, Chromatography, UF/DF TFF
Total Area
49,000 m2 (527,000 ft2)
Manufacturing Areaa
40,000 m2 (431,000 ft2)
TQA/QC Area
4,340 m2 (47,000 ft2)
Employees
Over 500 (170 in Production, 150 in QC/QA,70 in Development, 80 in Engineering)
Fermentation (E.coli)
10,000L Bioreactor x 2
Biochemical Reaction(in-vitro transcription
500L, 7500 L reactors
Purification
Up to 3kg per batch by Centrifugation, Chromatography, UF/DF TFF

Our Advantages

  • Rapid Lab-to-Pilot Development
  • Commercial-ready, CGMP Facilities
  • US FDA-standard Quality Management System
  • Innovative Process Development Capability
  • Bio CMC Regulatory Expertise
  • Co-development Experiences with Global Partners

Commercial Manufacturing Facilities

10,000L Fermentation/Recovery

Biochemical Reaction Drug Substance Manufacturing Line

Syringe Filling Lines

  • Prefild Syringe Filling Machine

    • DP LINE1
      Manufacturer
      Optima Inova (Germany)
      Capacity
      Max 2,500 syr./hrs
      IPC
      Off-line
      Filling Needle
      2EA
      Peristaltic Pump
      2EA
    • DP LINE2
      Manufacturer
      Bausch+Stroebel (Germany)
      Capacity
      Max 14,000 syr./hrs (Automatic 1% IPC, Vacuum Stoppering)
      IPC
      On-line
      Filling Needle
      10EA
      Peristaltic Pump
      10EA
  • Tub De-bagger

  • Tub Lead Paper Remover

  • PFS Filling Machine & RABS

Drug Product Packaging Lines

Syringe DenesterMax. Capacity : 400 syr./min
10 x 10 / 10 x 16 Size Tub
Auto Visual Inspection MachineMax. Capacity : 400 syr./min
Visual Inspection +
High Voltage Leakage Detection
Plunger Rod Assembly MachineMax. Capacity : 400 syr./min
Plunger rod assembly
Backstop assembly
Labeling
Syringe RenesterMax. Capacity : 300 syr./min
10 x 10 / 10 x 16 Size Tub

Process Development ​

Accelerated Pathway from Lab to Plant (APLP SolutionsTM) Workflow​

  • Early Stage Development​
    (Phase Ⅰ)​

    • Material preparation for proof-of-concept​
    • Establish initial process​​

    “Accelerated preparation of clinical ​materials”​

  • Mid-Late Stage Development​​
    (Phase Ⅱ & Ⅲ)
    ​​

    • Process/analytical/formulation optimization
    • Scale-up of manufacturing process​

    "Robust • Consistent • Economic process development for reliable production”​

  • Commercialization​​​

    • Reliable production and supply​
    • Consistent product quality​

    "Expansion of ​productivity and capacity”​

Cell to product in approximately6 monthsresulting from robust, scalabel process

Maximum fermentor capacity” of10,000 Lresulting from robust, scalabel process

Upstream Process (Fermentation & Recovery)​​

  • 12 parallel 1L glass fermentors​
  • 3 parallel Sartorius 30L stainless steel fermentors ​
  • Controlled temperature cabinets for flask cultures​
  • Freezers for WCB / harvest / intermediate​

Our fermentation experts provide exceptional development support for cell culture processes that meet future commercial requirements through systematic optimization of parameters​

Downstream Process (Purification)
Biochemical Reactions (PEGylation and Conjugation)​

  • Parallel reactors of various scale​​
  • Lab and pilot scale chromatography controllers (AKTA Avant, AKTA Pure, AKTA Pilot)​​
  • Lab scale chromatography columns: 6.6 – 50 mm (XK Column, LRC Column)​
  • Pilot scale chromatography columns: 50, 70, 100, 140, 200, 300, 450 (BPG Column, AxiChrom, Quickscale, Fineline Column )​
  • Lab and pilot scale UF/DF systems (TFF System, MF system)​
  • Cell Disruptor & POD System​

We use scientifically sound techniques including design-of-experiments approach for process optimization/characterization to achieve robust and economic processes. We map product quality and impurity reductions throughout development life cycle to generate superior quality products. Every step we take towards an efficient, scalable manufacturing process will deliver consistent product quality.​

Bio Analytics​

Methods Development and Characterization to GMP Testing Services​

  • Reliable and robust analytical methods are essential for successful drug development and commercialization. Our analytical capabilities help understand and characterize your molecule in a phase-appropriate manner.​
  • Services Provided
    • Defining product quality attributes​
    • Analytical method development, Qualification, and Validation​
    • Product characterization services (Primary and high order structure, Post-translational modification, Glycan
    • Disulfide bridge determination, product related impurities, in-vitro biological activity)​
    • GMP testing services (Batch release, stability, raw materials, and microbial tests)​
  • Research​​

    Analytical capability to support research and bio analytical characterization

  • Development​​

    Integrated efforts to develop analytical methods for process characterization and various assays

  • In-Process​​​​

    Method Development for the in-process testing to ensure product quality during manufacturing​​

  • Release Testing​​​​

    Method development to improve reliability and robustness for commercial product testing​​​

  • Regulatory CMC Documentation​​​​

    Preparation of CMC regulatory documentation package for submission and GMP inspection support​​​

QC GMP Testing Services​

  • Physico-Chemical Analyses​
    • In-Process Test​
    • DS/DP Release Test (Identity, purity & impurities, potency, and process/product residuals)​​
    • Stability Test (Long-term, accelerated, stress, photo-stability)​​​
    • Analytical Method Validation​​​

  • Raw Materials Analyses
    • Compendial Test according to pharmacopoeia (USP/ EP/ BP/ KP)​​
    • Analytical method verification for compendial method and validation for non-compendial method​

  • Cell-Based Assay
    • In-vitro Bioassay: Cell Proliferation & Product-specific Cell-Based Assayt​
    • Assay Readouts: Absorbance, Fluorescence, Luminescence, Time-resolved fluorescence, Luminescence​​​
    • Statistical Evaluation: Parallel Line Analysis, EC50 Determination, Equivalence Test​​​​

  • Microbial Test Method Development & Support​
    • Sterility Test (Isolator)​
    • Endotoxin Test (Kinetic, Gel-Clot)​
    • Disinfectant Efficacy Test Development​​
    • Microbial Identification Test (16s rRNA, MALDI-TOF system)​​​

Electronic Data Management System maintained according to US FDA 21 CFR Part 11​

  • LIMSLaboratoryInformationManagementSystem​

    • Test Management
      • Test requested through the SAP interface
      • Test request and reception​
      • Test result input and Review/Approval​
      • Print report
    • Laboratory Execution System
      • Automating Laboratory Equipment Data​
      • QR code system​
    • Stock / Maintenance / Trend
      • Stock Management
      • Equipment Management​
      • Trend​
  • LEMSLaboratoryEquipmentManagementSystem​

    • Monitoring Chamber Condition
      • Paperless digital recorder displays real-time measured data
      • Alert management​
      • Automatic data storage backup​
  • UMSUtilityMonitoringSystem​

    • Utility(EM & Water)Monitoring Data Management
      • Sample Schedule & Execution
      • Response to Environmental Contamination
        → Reduces Contamination Risk​
      • Analyze Utility / Environmental Trend
        → Removes Potential Risk​
  • Back-up System

    • Back-up of All Data Generated
      • Primary and Secondary Back-up
      • Automatic Daily Back-up
      • Empower – Back-up from Chromatographic Systems​
      • NuGenesis - Back-up from Standalone Instruments​

Long-Term Partnership – Extension of Collaboration

  • Strategic sourcing of key raw materials
    • Commercial/clinical contract manufacturing for recombinant protein
  • protein/peptide conjugates, pDNA, mRNA
    • Co-development for process improvement and CoGs reduction
    • Strategic sourcing of key raw materials