Biopharmaceutical Production

Biopharmaceutical Production - Milkaya | Bioprocessing & Cell Culture Systems

Biopharmaceutical Production

Comprehensive bioprocessing systems with cell culture bioreactors, fermentation technology, protein purification, downstream processing, and FDA/GMP compliant biotechnology manufacturing equipment for biologics production

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Complete Biopharmaceutical Manufacturing Solutions

From cell culture to final purification, our comprehensive bioprocessing systems ensure high-quality biologics production with precise control and regulatory compliance

Cell Culture Bioreactors

Advanced bioreactor systems with precise pH, dissolved oxygen, and temperature control for mammalian cell culture, microbial fermentation, and recombinant protein production with scalable configurations from bench to production scale.

  • Stirred-tank bioreactors
  • Single-use bioreactor systems
  • pH and DO control systems
  • Automated feeding systems
  • Scalable configurations
  • Process analytical technology

Technical Specifications

Volume 5L - 20,000L
Temperature 25-42°C ±0.1
pH Control ±0.05 pH units
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Microbial Fermentation Systems

High-performance fermentation systems for bacterial and yeast cultivation with advanced aeration, agitation, and monitoring systems for optimized microbial growth and metabolite production in biotechnology applications.

  • High-cell density fermentation
  • Advanced aeration systems
  • Multi-impeller agitation
  • Foam control systems
  • Continuous monitoring
  • Automated harvest systems

Technical Specifications

Capacity 10L - 15,000L
Aeration Rate 0.5-5 vvm
Agitation 50-500 rpm
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Protein Purification Systems

Comprehensive downstream processing systems with chromatography columns, membrane separation, and ultrafiltration for high-purity protein isolation and concentration with automated operation and buffer management.

  • Affinity chromatography systems
  • Ion exchange chromatography
  • Size exclusion systems
  • Ultrafiltration/diafiltration
  • Automated buffer preparation
  • Clean-in-place systems

Technical Specifications

Recovery 85-95%
Purity 95-99%
Throughput 10-1000 g/batch
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Downstream Processing Equipment

Integrated downstream processing systems including cell harvest, clarification, concentration, and formulation equipment for complete biologics processing from fermentation broth to final drug substance.

  • Cell harvesting systems
  • Clarification and filtration
  • Concentration systems
  • Formulation equipment
  • Buffer exchange systems
  • Final sterile filtration

Technical Specifications

Processing Rate 100-5000 L/h
Clarification 99.9% removal
Concentration 10-50x factor
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Single-Use Bioprocessing Systems

Flexible single-use bioreactors and processing equipment with disposable components, reduced contamination risk, and faster turnaround times for clinical and commercial biopharmaceutical production.

  • Single-use bioreactors
  • Disposable mixing systems
  • Single-use sensors
  • Sterile connection systems
  • Flexible bag systems
  • Rapid changeover capability

Technical Specifications

Volume Range 50L - 2000L
Sterility SAL 10⁻⁶
Setup Time 2-4 hours
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Process Analytical Technology (PAT)

Advanced process monitoring and control systems with real-time analytics, spectroscopy, and automated sampling for enhanced process understanding and quality control in biopharmaceutical manufacturing.

  • Real-time cell counting
  • NIR spectroscopy systems
  • Automated sampling systems
  • Multi-parameter monitoring
  • Data analytics integration
  • Process control systems

Technical Specifications

Response Time ≤30 seconds
Accuracy ±2%
Parameters 15+ simultaneous
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Media Preparation Systems

Automated media preparation and sterilization systems with precise nutrient mixing, pH adjustment, and sterile media distribution for consistent cell culture and fermentation media production.

  • Automated media preparation
  • Precise nutrient dosing
  • pH and conductivity control
  • Steam sterilization systems
  • Sterile media distribution
  • Recipe management systems

Technical Specifications

Batch Size 50L - 5000L
pH Accuracy ±0.02 units
Sterilization 121°C, 15 min
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Biosafety & Containment Systems

Comprehensive biosafety systems including containment equipment, waste treatment, and decontamination systems for safe handling of biological materials with regulatory compliance and environmental protection.

  • Biological safety cabinets
  • Containment systems
  • Waste treatment systems
  • Decontamination equipment
  • Air filtration systems
  • Emergency response systems

Technical Specifications

Containment BSL-1 to BSL-3
Air Flow 0.5 m/s inward
Efficiency 99.99% HEPA
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Biopharmaceutical Manufacturing Process Flow

Our integrated bioprocessing systems ensure complete control from cell banking to final drug product with optimal yield and regulatory compliance

Cell Banking & Expansion

Cell line development, banking, and expansion with controlled culture conditions and genetic stability monitoring

Fermentation & Culture

Large-scale cell culture and fermentation with precise environmental control and process optimization

Cell Harvesting

Cell separation and harvest using centrifugation, filtration, and clarification systems

Protein Purification

Multi-step chromatography and membrane-based purification for high-purity protein isolation

Quality Analysis

Comprehensive analytical testing including purity, potency, and safety characterization

Formulation & Fill-Finish

Final product formulation, sterile filling, and packaging for clinical and commercial distribution

Ready to Scale Your Biopharmaceutical Production?

Get expert consultation on FDA/GMP compliant bioprocessing systems and discover how Milkaya's advanced biotechnology equipment can accelerate your biologics development and manufacturing.

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