Development
GC Biopharma provides
High quality products
Accurately with high speed
GC Biopharma DP Development Service
With 50 years of experience of DP Development, GC Biopharma’s MSAT department provides high speed solution for client’s product.
Equipment
Formulation Screening
Uncle
Hunky
Lunatic
Big Kahuna
Lyophilization
FDM
Lyostar3 + SMART
Analytics
AURA
MFI
FMM
Uncle
Big Kahuna
Fill and Finish System
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- GC MS
- GC Wellbeing
- GCMedis
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- Overseas
- GC China Pharm
- Curevo
- GC Pharma do Brasil
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- Foundation
- MOGAM Institue
- GC Labs
- GC i-Med
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- Others
- GC Invacfarm
Formulation Development
- Molecule Characterization (Tm, Tagg, Particle Size, PDI)
- Composition Selection (= Pre- Formulation)
- Stability Predict
- 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)