The U.S. Food and Drug Administration regulates active pharmaceutical ingredient (API) manufacturing services and drug product manufacturing through Current Good Manufacturing Practices (CGMP). API and drug product manufacturing must comply with FDA guidelines and regulations for tracking each step, including raw material sourcing. Southwest Research Institute (SwRI) supports the pharmaceutical industry with CGMP manufacturing, applied R&D and technical services across the drug development supply chain.
API & DRUG PRODUCT MANUFACTURING SERVICES
Our drug substance manufacturing services use an integrated process evaluation and development approach for safe, compliant, and robust API manufacturing and CGMP processes, using FDA-inspected facilities with clean rooms and CGMP chromatography. Clients ranging from small pharmaceutical and biotechnology companies to government and academic institutions can choose comprehensive support or individual services.
CGMP Manufacturing Facilities
Our integrated pharmaceutical services support the pharmaceutical industry using these state-of-the-art laboratories, among others:
- FDA-inspected facilities
- ISO 9001:2008 quality system
- Clean rooms and pilot plants (Class 10,000 and 100,000)
- High-potency plant-scale Isolator and laboratory
- DEA-controlled substances handling (I-V)
- CGMP clinical supplies, storage and distribution
- ICH stability for API and drug product
Our CGMP manufacturing facility supports clinical supply for active pharmaceutical ingredients (API) analytical support and related services. For API manufacturing, we offer gram-to-kilogram-scale manufacturing in support of chemistry manufacturing controls (CMC) and investigational new drug (IND) submissions. We offer high-potency compound synthesis for Chemical Process Development and work with clients to transfer technology. Our analytical support for API manufacturing helps qualify and validate pharmaceutical ingredients in accordance with the FDA.
- Analytical & Regulated Projects – ICH stability studies, forced degradation, reference standard qualification
- Chromatographic Separation – Dedicated 40 kg scale chromatography (large-scale purification)
- Program Management & Regulatory Submissions
- Scale-up – Gram-to-kilogram-scale manufacturing (up to 200L)
Drug Product Manufacturing
SwRI’s drug product CGMP manufacturing facility support includes large, small, potent and controlled products, delivered in multiple dosage forms. There are many considerations for drug product manufacturing, including milling, granulation, emulsions, suspensions, and encapsulation techniques.
- Milling Services – Kilogram milling (ball-, stator-, pin-, jet- mills)
- Pharmaceutical Formulation Development – Specialized dosage forms (tablets/capsules, controlled release, drug releasing implants, parenteral/injectable (terminal sterilization: IM, IV, IP, intraarticular and Intranasal, inhalation)
- Analytical & Regulated Projects
Related Pharmaceutical Services
- Pharmaceutical Development
- Integrated Pharmaceutical Services
- Capsule Formulation Development
- Chemical Process Development
- Oral Formulation Development
- Tablet Formulation Development
Contact Joseph Persyn or call +1 210 522 2691 to learn more.