What We Do

You are an innovator.

 

You want a partner with the same mindset.

Arranta is seeking to lead the microbiome sector through process and analytical innovation and quality-by-design, state-of-the-art facilities, right-first-time manufacturing, and creative partnering strategies.

We are focused on our clients’ success.

Partner with us. Let us put our expertise, experience, resources, and facilities behind your programs to advance your LBP therapies through development into the clinic and in time to commercial launch and ongoing supply.

Organism types

  • Aerobic organisms
  • Obligate and facultative anaerobic bacteria
  • Spore forming bacteria

Product types

  • Single strains
  • Consortia
  • Genetically modified organisms
  • Donor derived products
  • BSL 1/2



Flexible partnership models to support your company’s unique needs

  • Traditional fee for service CDMO model
  • Dedicated and/or custom capacity
  • Looking for more than the typical CDMO?  We would love to discuss other strategic partnership models with you.

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Accelerated process development and clinical production platform

  • ALIVE Biotherapeutic ProductsTM manufacturing platform
  • actALIVE Biotherapeutic ProductsTM Fast-to-Clinic Program

Development Services

  • Colony Isolation, Screening and Genetic Stability
  • Cell Bank Process Optimization
  • Cell Banking (RCB, MCB, WCB)
  • Drug Substance Process Transfer or Development
    • Media development and screening
    • Fermentation process development
    • Cell harvesting development
    • Cyropreservative blend screening
    • Lyophilization process development
    • Spray drying process development
  • Drug Product Formulation and Process Development
    • Physicochemical characterization
    • Dosage form design and targeted delivery  
    • Design of development stability strategies
  • Late-Phase Process Characterization
    • Process Parameter Failure Modes and Effect Analysis
    • Scale-Down Model Qualification
    • Critical Process Parameter NOR and PAR definition

cGMP Services

  • Clinical and Commercial Drug Substance Manufacturing
    • Fermentation
    • Harvest Filtration
    • Lyophilization/Electrostatic Spray Drying (ESD)
    • Frozen Blend
    • Closed-system anaerobic processing, where required
  • Clinical and Commercial Drug Product Manufacturing
    • Various Drug Product dosage forms
    • Controlled environmental conditions, humidity, and oxygen
  • Process Performance Qualification
  • Secondary Packaging, including blisters,  bottles, sachets, etc.

Analytical Services

  • Implementation of standard Arranta assays
    • Traditional Potency Assays (CFU)
    • Advanced Characterization Assays (TCC/VCC, Lag time)
  • Assay development or transfer
  • Assay qualification
  • Assay Validation
  • QC testing
    • Release testing
    • Accelerated and long-term stability studies

Regulatory Support

  • CMC Section authorship or review
  • Mock Regulatory Inspections
  • Pre-Approval Inspections
  • Annual Approved Product Reviews
  • Routine GMP Inspections

Arranta Bio’s Facilities

Our facilities in Gainesville, Florida and Watertown, Massachusetts are state-of-the-art purpose-built for LBP Manufacturing. Our new facility in Boxborough, MA sitting on a 200-acre campus is being constructed to the same best in class industry standards 

  • Anaerobic processing from thaw through drug product
  • Low humidity processing from drying through packaging
  • Single-use technology
  • Closed processing of all operations
  • Uni-directional flow of people, product, materials, and waste
  • Cleaning and disinfection control strategy to prevent cross-contamination between products, including HVAC room isolation and VHP between products
  • Environmental monitoring program to ensure adequacy of cleaning and disinfection procedures, and environmental and process controls
  • Built in compliance with
    • FDA Code of Federal Regulations (Part 21)
    • ICH Guidelines

1 Gainesville, FL

22,000 Sq. Ft.

Offering

• Analytical and Manufacturing Process Development
• cGMP Cell Banking
• Early Clinical Manufacturing of Drug Substance and Drug Product

cGMP Suites

• Cell Banking Suite
• Fermentation Suites
• Lyophilization Suites
• Drug Product Suites

cGMP Scales

• 50L to 2x250L single-use bioreactors
• 30L single-use fermenter
• Lyophilization up to 23ft2
• Up to 30,000 capsules; sachets

2 Watertown, MA

80,000 Sq. Ft.

Offerings

• Analytical and Manufacturing Process Development
• Process Characterization and Performance Qualification
• cGMP Cell Banking
• Late-stage clinical supply of Drug Substance and Drug Product
• Commercial supply of Drug Substance and Drug Product
• Multi-suite, dedicated client spaces
• Secondary Packaging

cGMP Suites

• Fermentation Suites
• Lyophilization Suites
• Drug Product Suites

cGMP Scales

• 50L to 2x2000L Single-use bioreactors
• 30L to 300L Single-use fermenters
• 72 ft2 Lyophilizers
• 50,000+ capsules

3 Boxborough, MA

130,000 Sq. Ft.; operational early 2022

Offerings

• Clinical and Commercial Supply of Drug Substance and Drug Product
• Multi-suite, dedicated client spaces
• Secondary Packaging

cGMP Suites

• Fermentation Suites
• Lyophilization Suites
• Drug Product Suites

cGMP Scales
  • Up to 2x2000L Single-use bioreactors
  • 30L to 1000L Single-use fermenters
  • Lyophilization and spray drying
  • > 100,000 capsules
  • Custom capacity in collaboration with clients

Browse Opportunities & Apply

Ready to take the next step in your career while pioneering pharmaceutical innovation? We are continuously seeking people of all backgrounds, skillsets and experience levels to join our growing team.