Development
모든 고객에게
신속하고 정확하게
고품질 결과를 전달합니다
GC Biopharma DP Development Service
50년 이상의 제약 개발의 경험을 바탕으로 MSAT 본부에서 후기 공정 개발을 담당하며 고객사 제품의 개발속도 및 효율성 향상을 통해 신속하고 정확하게 고품질의 결과를 전달합니다.
보유장비
Formulation Screening
Uncle
Hunky
Lunatic
Big Kahuna
Lyophilization
FDM
Lyostar3 + SMART
Analytics
AURA
MFI
FMM
Uncle
Big Kahuna
Fill and Finish System
Formulation Development
- Molecule Characterization (Tm, Tagg, Particle Size, PDI)
- Composition Selection (= Pre- Formulation)
- Stability Predcict
- Drug Product Form (Solution & Dry Powder)
- Stability Study (DoE)
Process Development
- Sterile Filtration Study (Membrane, Sizing)
- Overfill Study (Filling Amount)
- Holding Time Stability
- Filling (Nozzle Position)
Final Bulk Manufacturing
- DS Thawing
- Compounding (=Mixing)
- Filtration
Drug Product Manufacturing
- Preparation of Primary Packaging Materials
- Aseptic Filling
- Lyophilization
- Reference Manufacturing
Process Development
- Visual Inspection
- Release Test
- Stability Test
- Product Characterization
Drug Product Manufacturing
- Risk Assessment – Process, Quality (Release, Stability)
- Identification of Critical Quality Attributes
- Identification of Critical Process Parameters
- At-Scale Runs (=Commercial Scale)
- Scale-Down Model (SDM) Qualification (F/T, Mixing, Sterile filter, Filling, Lyophilization, Capping)
- Unit Process-Quality Design Space
- Process Control Strategy
- Buffer Holding Time Stability
- Final Bulk Solution Holding Time Stability
Molecule Characterization
- High Throughput protein stability
- 3 detection methods (Full spectrum fluorescence, SLS, DLS)
- Irreversible unfolding
- Faster: best for screening
- Tm/Tagg
- Isothermal stability
- Sizing/Polydispersity
- B22/kD
Construct Screening
- High Throughput protein stability
- Equilibrium unfolding
- Stress: Ambient chemical denaturant
- Faster: best for screening
- Detection: Fluorescence
- C1/2/△G/Agg Path/△Gtrend
Protein Content
- High Throughput protein content
- Dynamic Range (0.02 – 200 mg/mL)
- Sample volume: 2uL
Buffer preparation & Analysis
- Automated Workflows
- Making part: Buffer preparation, Buffer exchange(DF)
- Analysis part: Visual Inspection (Color, Turbidity, Particle (Visible)), pH, Viscosity
- Agitation stress
Freeze Dry Microscopy
- Measurement of Collapse Temperature (Tc)
- Factors required to use the SMART freeze dryer
Smart Freeze Dryer
- Automated cycle development
- The cycle can be performed with minimal information (Tc, Fill volume)
- The optimal cycle can be derived with minimal experimentation
- Used as an equivalence factor according to Tech transfer and scale change
Aggregate and particle counting, sizing and ID
- Aggregate and particle counting sizing, and ID
- Particle size range : 1um – 5mm (ECD)
- Sample volume: 10 uL – 30 uL
- 96 Sample Automation
- Air bubbles not counted as particles
- Technology : Backgrounded Membrane Imaging (BMI), Fluorescence Membrane Microscopy (FMM)
Micro-Flow Imaging, MFI
- Micro-Flow Imaging, MFI
- Image-based particle analysis, Count, Conc.
- Particle size range : 1um – 70um
- Sample volume : 1 – 2 mL
- Distinguish silicone oil droplets from aggregates
Flourescence Membrane Microscopy Characterization using CE
- Capillary electrophoresis, CE
- UV/Vis : 200, 214, 254, 280nm
- Protein purity analysis (CE-SDS), Charge heterogeneity (cIEF)
- Glycan analysis
- Peptide/Protein characterization analysis
Static Light Scattering, SLS
Dynamic Light Scattering, DLS
- SLS: Average intensity, Particle molecular weight and concentration
- SLS is ideal for detecting the moment when aggregation begins because it is a direct measurement that increases the moment molecular weight increases.
- DLS: Size based on the diffusion of particles in solution.
Visible Particle analysis
- Visual Inspection (Particle formation)
- Non-destructive measurement
- Method of measurement : Initial vial image -> 50 ms later -> Only moving particles identified
Fill and Finish System
STEP 01. Filling machine
- 1. Peristaltic pump
- 2. Customizing needle diameter
- 3. Filling amount auto-recording
- 4. Needle position & filling speed
Assessment
STEP 02. Stoppering machine
- Stoppering
- - Before N2 Charged : N2 79.1%
- - After N2 Charged : N2 99.6%
(by Head space gas analyzer)
STEP 03. Crimping machine
- Crimping parameter Assessment
- - Crimping pressure
(by height & disk distance)