Cell Culture Grade Amino Acids - Biotechnology Applications
Industrial Premium
Pharmaceutical Ingredient

Cell Culture Grade Amino Acids

Premium high-purity amino acids engineered for demanding biotechnology applications including cell culture media formulation, protein production, vaccine manufacturing, and research applications. Our cell culture grade amino acids deliver exceptional purity, consistent performance, and reliable biocompatibility for critical biotechnology processes requiring superior building blocks with stringent regulatory compliance standards.

  • High Cell Culture Purity
  • Superior Biocompatibility
  • USP/EP Grade Quality
  • Consistent Performance
  • Biotechnology Applications
  • Research Grade
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Technical Specifications

Product Type: Cell Culture Grade Amino Acids
Grade: USP/Cell Culture/Pharmaceutical Grade
Physical State: White crystalline powders
Purity: ≥ 98.5% (Individual amino acids)
Loss on Drying: ≤ 0.5%
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 10 ppm
Endotoxin Level: ≤ 10 EU/g
Total Microbial Count: ≤ 100 CFU/g
Sterility: Gamma irradiation available
Storage Conditions: 2-8°C, dry conditions
Shelf Life: 3 years from manufacture
Packaging Options: 100g, 500g, 1kg bottles

Applications

Cell Culture Media
Protein Synthesis
Injectable Formulations
Nutritional Supplements
Parenteral Solutions
Therapeutic Applications

Industry-Specific Grades

DRAVYOM offers specialized amino acid grades tailored for different pharmaceutical and biotechnology requirements, ensuring optimal performance and regulatory compliance.

Cell Culture Grade
Purity: ≥ 99.0% Endotoxin: ≤ 10 EU/g Sterility: Available Application: Cell culture media
USP Grade
Purity: ≥ 98.5% Heavy Metals: ≤ 10 ppm Microbial: ≤ 100 CFU/g Application: Pharmaceutical formulations
Food Grade
Purity: ≥ 98.0% Lead: ≤ 2 ppm Arsenic: ≤ 1 ppm Application: Nutritional supplements
Injectable Grade
Sterility: Guaranteed Pyrogen: ≤ 0.5 EU/mL Particulates: ≤ 25 particles/mL Application: Parenteral solutions

Quality Standards

DRAVYOM's Cell Culture Grade Amino Acids are manufactured under cGMP conditions, meeting USP and pharmaceutical standards for biotechnology applications.

cGMP Certified Manufacturing
USP Monograph Compliance
≥ 98.5% Pharmaceutical Purity
Cell Culture Grade Quality
Complete Analytical Testing
Cold Chain Storage
Batch Release Documentation
Biotechnology Grade Support

Advanced Chemical Properties & Performance

Pharmaceutical grade Amino Acids exhibit excellent chemical properties for drug formulation and nutritional applications. Their zwitterionic nature, high purity standards, and biocompatibility make them ideal for injectable medications, oral formulations, nutritional supplements, and various pharmaceutical manufacturing processes.

Chemical Properties
General Formula: R-CH(NH₂)-COOH
Ionic Nature: Zwitterionic compounds
Chirality: L-configuration (pharmaceutical)
Solubility: Variable water solubility
Physical Properties
Appearance: White crystalline powder
Melting Point: Varies by amino acid type
pH: Near isoelectric point
Stability: Stable under proper storage
Pharmaceutical Performance
Bioavailability: Excellent absorption profile
Compatibility: Compatible with excipients
Stability: Stable in formulations
Nutritional Value: Essential nutrients
Quality Specifications
Purity: ≥98.5% USP grade
Heavy Metals: ≤10 ppm
Residual Solvents: Within ICH limits
Microbiological: Meets USP standards
Stability Properties
Shelf Life: 3-5 years (proper storage)
Temperature Sensitivity: Store below 25°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Keep in dry conditions

Performance Characteristics

Performance metrics demonstrate Pharmaceutical Amino Acids' effectiveness in drug formulations with excellent bioavailability, superior stability, reliable quality consistency, and consistent therapeutic performance across pharmaceutical applications.

Bioavailability

Absorption: >95% bioavailability

Excellent therapeutic uptake
Formulation Stability

Duration: 24+ months shelf life

Superior pharmaceutical stability
Purity Level

Grade: ≥98.5% USP quality

Pharmaceutical grade purity
Storage Stability

Conditions: Stable under ambient storage

Convenient handling requirements
Regulatory Compliance

Standards: USP/EP/JP compliant

Global regulatory acceptance
Clinical Performance

Efficacy: Proven therapeutic outcomes

Clinically validated results

Safety Information

Generally recognized as safe pharmaceutical ingredients with minimal health hazards. Handle with standard pharmaceutical manufacturing protective equipment including gloves and safety glasses. Ensure adequate ventilation during processing. Follow Good Manufacturing Practices (GMP) for pharmaceutical handling.

Generally Safe
Pharmaceutical Grade
Biocompatible

Storage & Handling

Store in original pharmaceutical containers in a cool, dry place protected from light and moisture. Keep containers tightly closed to maintain purity and prevent contamination. Use GMP-compliant handling procedures and maintain proper inventory management for pharmaceutical manufacturing facilities.

Store below 25°C
Protect from light
Pharmaceutical containers
GMP handling protocols

Chemical Mechanisms & Reaction Pathways

Amino acids exhibit diverse chemical behaviors through their unique side chains and functional groups, enabling complex biochemical processes essential for pharmaceutical and biotechnology applications with predictable interaction patterns.

Peptide Bond Formation

Amino acid condensation reactions forming peptide linkages in pharmaceutical synthesis

Essential for protein-based drug development
pH-Dependent Behavior

Zwitterionic properties enabling pH-controlled drug delivery systems

Critical for formulation optimization
Side Chain Reactivity

Specific amino acid side chain reactions for drug conjugation and modification

Enables targeted therapeutic applications
Metabolic Pathways

Amino acid metabolism and bioavailability in pharmaceutical systems

Important for drug efficacy and safety

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical-grade amino acids meet international standards with complete documentation packages supporting GMP requirements and regulatory submissions.

Pharmaceutical Standards

USP, EP, and JP monograph compliance for pharmaceutical applications

GMP Compliance

Good Manufacturing Practice protocols and quality system requirements

Safety Documentation

Complete safety data sheets and pharmaceutical handling protocols

International Registration

DMF filings and regulatory master file documentation

Quality Documentation

Certificates of analysis and pharmaceutical quality assurance

Cold Chain

Temperature-controlled transportation and pharmaceutical logistics

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical and biotechnology support team provides comprehensive guidance, formulation assistance, and technical expertise to optimize amino acid applications in pharmaceutical and biotechnology development.

Pharmaceutical Support
  • Formulation development assistance
  • Drug delivery system optimization
  • Stability testing guidance
  • Regulatory submission support
Biotechnology Services
  • Cell culture medium optimization
  • Protein expression system development
  • Purification process design
  • Bioprocess scale-up support
Quality Services
  • GMP compliance consultation
  • Method validation support
  • Quality system development
  • Analytical method transfer
Supply Solutions
  • Pharmaceutical-grade packaging
  • Cold chain logistics
  • Custom formulation services
  • Inventory management programs

Environmental Impact & Sustainability

Our pharmaceutical-grade amino acid production emphasizes environmental responsibility through biotechnology-based manufacturing, waste minimization, and comprehensive environmental impact management for sustainable pharmaceutical development.

Green Synthesis

Biotechnology-based production with minimal environmental impact

Sustainable Pharma

Supporting sustainable pharmaceutical manufacturing practices

Clean Production

Energy-efficient fermentation with emission controls

Waste Management

Pharmaceutical waste disposal and recycling programs

Environmental Standards

ISO 14001 environmental management system compliance

Packaging Programs

Recyclable pharmaceutical packaging and container return

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical amino acid manufacturing facility employs advanced biotechnology and quality systems to ensure consistent pharmaceutical-grade quality and performance across all production batches for pharmaceutical and biotechnology applications.

Biotechnology Production

Advanced fermentation and purification technology for pharmaceutical-grade amino acids

State-of-the-art bioprocessing capabilities
Quality Testing

Comprehensive testing including purity, potency, and pharmaceutical specifications

USP/EP/JP method validation and compliance
GMP Systems

cGMP compliance with pharmaceutical quality management systems

FDA and EMA inspection-ready facilities
Pharmaceutical Packaging

ICH-compliant packaging with pharmaceutical-grade containers

Controlled atmosphere packaging for stability

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating amino acid effectiveness across drug development and biotechnology applications with validated performance metrics and pharmaceutical industry adoption.

Pharmaceutical Industry
Quality Record: 99.8% pharmaceutical compliance Performance: Consistent bioavailability profiles Regulatory Success: 95% submission approval rate
Biotechnology Companies
Cell Culture: Superior growth performance Protein Expression: Enhanced yield optimization Customer Satisfaction: 97% biotechnology approval
Contract Manufacturing
Process Reliability: 99.5% batch success rate Supply Chain: 100% on-time pharmaceutical delivery Cost Efficiency: 25% reduction in formulation costs

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

cGMP-compliant manufacturing with pharmaceutical regulatory expertise and drug development support

Biotechnology Innovation

Advanced fermentation technology with cell culture optimization and bioprocess development

Quality Systems

Comprehensive quality management with pharmaceutical-grade documentation and traceability

Reliable Supply

Consistent pharmaceutical supply chain with cold chain logistics and inventory management

Regulatory Support

DMF filing assistance with regulatory submission support and global compliance expertise

Partnership Approach

Long-term pharmaceutical partnerships with technical collaboration and formulation development