cGMP manufacturing of LBP drug substance is performed in manufacturing suites and areas maintained to FDA guidance on “Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms” and in compliance with the FDA Code of Federal Regulations (Part 21) and ICH guidelines. Our manufacturing suites can accommodate a range of production processes.
- Clinical and commercial LBP drug substance production
- Fermentation of aerobic organisms in single-use fermentors from 30L to 1000L
- Production of obligate and facultative anaerobes in single-use bioreactors from 50L to 2000L
- Genetically engineered strains
- BSL-2 and spore-forming species
- Single strains or consortia
- Harvest TFF and centrifugation
- Spray drying
- Liquid or dried bulk drug substance
- Closed-system anaerobic processing, where required
cGMP manufacturing of LBP drug product is performed in manufacturing suites and areas maintained to appropriate FDA and EMA regulatory requirements and ICH guidelines and in compliance with the FDA Code of Federal Regulations (Part 21). The LBP drug product manufacturing suites can accommodate a range of production processes.
- Clinical and Commercial LBP drug product manufacturing
- Various drug product dosage forms including capsules, sachets, and flexibility for other formats
- Packaging, including blisters and bottles
- Controlled environmental conditions, humidity, and low-oxygen controls
Process validation is a critical part of ensuring product quality. Arranta approaches process validation in accordance with FDA guidance “Process Validation: General Principles and Practices.”
- Process Design, including justification of process control parameters, ranges of incoming material or consumable quality, and equipment set-points and parameters
- Process Qualification, including facility design and qualification of utilities and equipment, process performance qualification, and use of PPQ plans, protocols and reports
- Continued Process Verification to monitor and track process control, including product and process data
A quality culture and system are at the center of everything we do. Arranta Bio has a robust, phase-appropriate Quality Management System and we use best-practice software and systems for managing quality and ensuring compliance at every step.
- cGMP compliance with 21 CFR 210 and 211, ICH guidelines, and FDA guidance
- Use of best-practice software and systems (deviations, CAPA, change control, investigations, risk management), automated equipment monitoring and asset management, training, resource planning, data integrity and security
- Regulatory submission support
Arranta Bio offers flexible business models to meet the supply needs and stage-of development of your product, including:
- Traditional CDMO, fee-for-service development activities and pay per batch with multi-product/multi-client labs and suites, using Work Statements to reserve capacity.
- Dedicated capacity, for customers with sufficient demand and a need to support supply through licensure. We offer flexible scheduling for campaigns or fully-dedicated capacity to support ramping up to maximum output with person-in-plant for technical oversight and fixed capacity access fee plus variable costs.
- Custom manufacturing partnerships, for advanced therapy product innovators requiring dedicated manufacturing capacity tailored to the needs of your program. Learn more