Specialties
High Containment & Cytotoxic Capabilities
CPS is one of the few service providers to offer a complete solution for high containment and cytotoxic compounds from API development and manufacturing to development and commercial manufacturing of the finished product.
HPAPI Development and Manufacturing
For API development and commercial manufacturing of highly potent and cytotoxic compounds, Dr. Reddy's has 2 facilities in India (Hyderabad and Vizag) to handle products with Occupational Exposure Limits (OEL) of 0.2µg/m3 for 8 hours. The scale of development at both facilities ranges from sub Liter to multiple Liters. The scale of manufacturing at both facilities ranges from 20 Liters to 2500 Liters.
Salient features:
Product Protection
- Purified Water system (USP grade with Endotoxin control)
- HVAC System dedicated to this module
- Closed operation system (Isolators)
- CIP system.
Personnel Protection
- Use of Isolator as the primary protection
- Isolators designed to achieve 0.1 µg/m3 for 8 hours working
- Use of Gown as the secondary protection
- Handling of potent materials within Isolator.
- Movement of material through RTP (Rapid Transfer Port) in Canister
- Mist Shower at exit of Production module ( For emergency situation)
Environmental Protection
- HVAC System with HEPA in return
- Differential pressure for containment
- Decontamination of waste
- Isolator exhaust connected with scrubber
Cytotoxic Formulations
Dosage Form Development
Dr Reddy’s has dedicated development labs for Cytotoxic Dosage development. We offer developmental services for Cytotoxic compounds in following dosage forms
- Tablets
- Capsules
- Liquid filled in hard gelatin capsules
- Semi solid
- Liquids
- Liquid Injectables
- Lyophilized powder for injection
Clinical Trial Material and Commercial Manufacturing
Dr Reddy’s has a dedicated state of the art cGMP High potency dosage manufacturing facility for the clinical trial manufacture and commercial manufacture. The facility is designed to cater both small and large requirement for Clinical trial material and the commercial requirements.
The following Cytotoxic dosage forms are offered:
- Tablets
- Capsules
- Liquid Injectables
- Lyophilized powder for injection
Dr Ready’s conducts intensive industrial hygiene monitoring studies. The facility has independent modules, closed handling systems (Isolators, cRABS etc), split valves etc to ensure the safety of the trained work force and for environmental protection.
Clinical Trial Material for First in Human Studies (FIH)
Dr Reddy's has Xcelodose capsule filling machine, which can even fill micro quantities of API directly into the capsules. This technology is best suited for supply of FIH material.
Salient features:
- Precise metering of powdered drug into capsules
- Minimal development time
- Reduced API consumption
- Improved quality and significant reduction in cost and time.
All the above activities are supported by extensive range of in house analytical services.