Pharmaceutical Grade Freeze-Dried Powder
GMP-Compliant Freeze-Dried Powder Manufacturing
ISO 13485 certified facility specializing in pharmaceutical-grade freeze-drying for probiotics, enzymes, vaccines, and biologics. FDA-registered with complete documentation support for regulatory submissions worldwide.
Pharmaceutical-Grade Freeze-Dried Products
Our pharmaceutical lyophilization services maintain biological activity, stability, and potency of temperature-sensitive compounds. Every batch undergoes rigorous quality testing with full traceability.
Probiotic Powder
High-potency freeze-dried probiotics with guaranteed CFU counts. Lactobacillus, Bifidobacterium, and multi-strain formulations.
- Potency: 10 billion to 500 billion CFU/g
- Viability: >90% after 24 months at 25°C
- Moisture: <3% (optimal stability)
- Strains: L. acidophilus, B. longum, L. rhamnosus, etc.
- Applications: Dietary supplements, functional foods, pharmaceuticals
Enzyme Formulations
Stabilized enzyme powders maintaining enzymatic activity. Protease, lipase, amylase, and custom enzyme blends.
- Activity: Customizable (1,000-100,000 U/g)
- Stability: >85% activity retention after 18 months
- pH Range: Optimized for target application
- Types: Digestive enzymes, industrial enzymes, therapeutic enzymes
- Certifications: USP, EP, JP compliant
Peptide & Protein Powder
Lyophilized peptides and proteins with preserved tertiary structure. Collagen peptides, whey protein isolate, bioactive peptides.
- Purity: >95% (HPLC verified)
- Molecular Weight: 500-50,000 Da
- Solubility: Instant dissolution in water
- Applications: Injectable drugs, oral supplements, cosmetic ingredients
- Packaging: Sterile vials or nitrogen-flushed pouches
Vaccine & Biologic Stabilization
Specialized lyophilization for vaccines, antibodies, and cell-based therapies. Ultra-low temperature processing with cryoprotectants.
- Temperature Control: -80°C to +40°C precision
- Sterility: Aseptic processing in ISO 5 environment
- Reconstitution: <60 seconds with provided diluent
- Stability: 2-8°C storage for 24+ months
- Compliance: ICH Q5C guidelines
Advanced Pharmaceutical Lyophilization
Our pharmaceutical-grade freeze-drying equipment and processes meet the strictest regulatory requirements. Every parameter is monitored, recorded, and validated.
Equipment Specifications
10kg – 500kg per batch
-80°C to +60°C (±0.5°C accuracy)
0.01 – 1.0 mbar (adjustable)
2.5 – 15 m² (multiple units)
50-200 kg ice/cycle
24-72 hours (product dependent)
Quality Control Parameters
<3% (Karl Fischer titration)
<0.3 (optimal stability)
50-500 μm (laser diffraction)
0.1-0.4 g/mL (typical range)
<1000 CFU/g (non-probiotic)
<10 ppm (ICP-MS analysis)
Pharmaceutical Freeze-Drying Process
Our validated lyophilization process ensures consistent product quality, batch-to-batch reproducibility, and regulatory compliance. Every step is documented with electronic batch records.
Phase 1: Pre-Freezing Preparation
Raw material verification, formulation preparation, and sterile filtration in ISO 5 cleanroom environment.
- Identity testing of active pharmaceutical ingredients (API)
- Precise weighing and mixing under controlled conditions
- pH adjustment and stabilizer addition as per formulation
- 0.22μm sterile filtration for injectable products
- Aseptic filling into pre-sterilized containers
Phase 2: Controlled-Rate Freezing
Programmable freezing protocol optimized for each product to prevent ice crystal damage and maintain molecular structure.
- Initial cooling from +20°C to -5°C at 1°C/min
- Nucleation induction at -5°C (controlled ice formation)
- Rapid freezing to -40°C at 2-5°C/min
- Annealing step at -25°C for 2-4 hours (optional)
- Final freezing to -45°C for complete solidification
Phase 3: Primary Drying (Sublimation)
Vacuum application with gradual temperature increase removes 90-95% of water content through ice sublimation.
- Vacuum reduction to 0.05-0.1 mbar
- Shelf temperature increase to -10°C to +10°C
- Duration: 18-48 hours (product dependent)
- Real-time monitoring of chamber pressure and temperature
- Endpoint determination via pressure rise test
Phase 4: Secondary Drying (Desorption)
Temperature elevation removes bound water molecules to achieve target moisture content for long-term stability.
- Shelf temperature increase to +20°C to +40°C
- Vacuum maintained at 0.01-0.05 mbar
- Duration: 4-12 hours
- Final moisture content: <3% (Karl Fischer)
- Gradual return to atmospheric pressure with nitrogen
Comprehensive Testing & Documentation
Every pharmaceutical batch undergoes extensive quality control testing. We provide complete documentation packages for regulatory submissions.
Physical Testing
- Appearance and color evaluation
- Moisture content (Karl Fischer titration)
- Water activity (aw) measurement
- Particle size distribution (laser diffraction)
- Bulk and tapped density
- Reconstitution time testing
- pH measurement of reconstituted solution
Chemical Analysis
- Active ingredient potency (HPLC/GC)
- Impurity profiling and degradation products
- Heavy metals analysis (ICP-MS)
- Residual solvents (GC-MS)
- Protein content (Bradford/Lowry assay)
- Amino acid composition
- Molecular weight verification (SDS-PAGE)
Microbiological Testing
- Total aerobic microbial count
- Yeast and mold count
- Absence of pathogens (E. coli, Salmonella, S. aureus)
- Endotoxin testing (LAL assay)
- Sterility testing (for injectable products)
- Probiotic viability count (for probiotic products)
Stability Studies
- Accelerated stability (40°C/75% RH, 6 months)
- Long-term stability (25°C/60% RH, 24 months)
- Refrigerated stability (2-8°C, 36 months)
- Freeze-thaw cycle testing
- Photostability testing (ICH Q1B)
- Real-time aging studies
Global Regulatory Compliance
BioFreeze provides comprehensive documentation support for pharmaceutical product registration worldwide. Our quality management system meets international regulatory standards.
United States (FDA)
FDA-registered facility (FEI number provided). Complete DMF (Drug Master File) support for pharmaceutical ingredients.
- Certificate of Analysis (CoA)
- Manufacturing process description
- Validation protocols and reports
- Stability data packages
- GMP compliance certificate
- Allergen and BSE/TSE statements
European Union (EMA)
ISO 13485:2016 certified. REACH compliance for chemical substances. CEP (Certificate of Suitability) support available.
- European Pharmacopoeia (EP) compliance
- REACH registration documentation
- Active Substance Master File (ASMF)
- GMP certificate from competent authority
- Residual solvents declaration
- Environmental risk assessment
Japan (PMDA)
Japanese Pharmacopoeia (JP) compliant manufacturing. Documentation in Japanese available upon request.
- Master File registration support
- JP monograph compliance certificate
- Manufacturing site audit reports
- Quality assurance documentation
- Stability data (ICH guidelines)
Other Markets
Experience with regulatory submissions in Canada (Health Canada), Australia (TGA), Korea (MFDS), and emerging markets.
- WHO GMP certification
- Halal certification (JAKIM, MUI)
- Kosher certification (OU, OK)
- Organic certification (USDA, EU)
- Non-GMO verification
Pharmaceutical Product Applications
Our freeze-dried pharmaceutical ingredients are used in various therapeutic areas and dosage forms.
Oral Solid Dosage Forms
Tablets, capsules, sachets, and orally disintegrating tablets (ODT) containing freeze-dried active ingredients.
- Probiotic capsules (10-50 billion CFU)
- Digestive enzyme tablets
- Protein supplement powders
- Instant beverage mixes
Injectable Formulations
Lyophilized vials for reconstitution before injection. Maintains sterility and stability of biologics.
- Peptide and protein drugs
- Monoclonal antibodies
- Vaccines and immunotherapies
- Diagnostic reagents
Topical Applications
Freeze-dried ingredients for reconstitution into creams, gels, and serums.
- Growth factors for wound healing
- Enzyme-based debriding agents
- Probiotic skincare actives
- Peptide anti-aging formulations
Flexible Order Quantities & Competitive Pricing
We accommodate projects of all sizes, from R&D sample batches to commercial-scale production. Contact us for detailed quotation based on your specific requirements.
Sample / Trial Batch
Ideal for product development, stability testing, and regulatory sample preparation.
- Minimum order: 1kg
- Lead time: 2-3 weeks
- Full CoA provided
- Process optimization included
- Pricing: Contact for quote
Small-Medium Scale
Suitable for market launch, clinical trials, and growing brands.
- Competitive bulk pricing
- Lead time: 3-4 weeks
- Stability data support
- Regulatory documentation
- Volume discounts available
Commercial Production
Large-scale manufacturing with dedicated production scheduling and priority support.
- Best pricing per kg
- Guaranteed capacity allocation
- Annual supply agreements
- Technical account manager
- Custom packaging options
Request Pharmaceutical-Grade Freeze-Drying Quote
Our pharmaceutical lyophilization specialists are ready to discuss your project requirements. We provide free technical consultation, sample testing, and detailed proposals including process parameters, timeline, and pricing.
ISO 13485 Certified | FDA Registered | GMP Compliant | Response within 24 hours