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HPAPIs

High-Potency Molecules CDMO Services

From complex chemistry to contained clinical and commercial manufacturing, we enable the safe and reliable development of high-potency APIs and Intermediates.

Our dedicated HPAPI CDMO platform supports the development and manufacturing of oncology, corticosteroids, and other high-potency molecules from laboratory scale through commercial production. With robust containment systems, dedicated infrastructure, and experienced technical teams, we help clients accelerate programs while maintaining the highest standards of operator safety, product quality, and process control.

End-to-End HPAPI Development & Manufacturing

  • Route scouting, process development, optimization, and scale-up for complex high-potency molecules.
  • Seamless transition from laboratory development to pilot and manufacturing scale with dedicated HPAPI infrastructure.
  • Two dedicated manufacturing blocks with three separate production lines and reactor capacities ranging from 250 L to 3,000 L. Total Volume: 45 KL/M3, Total Reactors: 27
  • Designed to handle potent compounds with OELs of 1-10 µg/m³ (OEB 4). Critical operations are performed in isolators to minimize operator exposure and cross-contamination risks.
  • Filtration, drying, milling, sifting, sampling, and packaging are performed in isolators for enhanced containment throughout the manufacturing process.
  • Dedicated analytical labs and QC supporting method development, characterization, impurity profiling, in-process testing, and release requirements.
  • Dedicated warehouse infrastructure for controlled sampling and dispensing of potent starting materials and intermediates.
  • Generated waste is deactivated prior to disposal, supporting safe and compliant handling of potent materials.

APL’s Approach to High-Potency Molecules

At APL, our high-potency molecule strategy is built around risk-based containment, engineered
controls, and safe product handling throughout development and manufacturing.

  • Hazard & Exposure Assessment
    Evaluate the toxicological and occupational hazards of the compound and establish the appropriate Occupational Exposure Limit (OEL) and containment requirements.
  • Containment Strategy
    Define and implement the appropriate containment strategy for each stage of process development, scale-up, and manufacturing.
  • Engineering Controls
    Select suitable engineering controls, including HVAC, HEPA filtration, ventilation, pressure differentials, and containment systems, to minimize exposure and prevent cross-contamination.
  • Equipment & Safe Handling Procedures
    Select appropriate equipment and establish controlled procedures for critical operations such as sampling, weighing, charging, blending, filtration, drying, milling, and packaging, supported by appropriate PPE and operating practices.
  • Packaging & Product Protection
    Define suitable primary and secondary packaging systems based on the potency, handling requirements, transportation conditions, and customer requirements.

Our objective is simple: Design containment into the process from the beginning – protecting people, products, and the environment while enabling reliable scale-up and manufacturing services.

APL’s Containment Strategies

APL employs a layered containment approach to safely handle high-potency molecules, selecting the appropriate technology based on the compound hazard, OEL, process operation, and scale.

  • Local Exhaust Ventilation (LEV) with PPE
    Engineered local exhaust systems combined with appropriate PPE to control exposure during material handling and processing.
  • Glove Boxes with Active/Passive Valve Systems
    Fully contained systems with controlled material transfer through active/passive valve mechanisms, minimizing operator exposure and release of potent materials.
  • Flexible Isolators
    Flexible containment systems for operations requiring controlled handling, sampling, dispensing, and other material-transfer activities.
  • Rigid Isolators
    Robust, high-integrity containment systems for critical and higher-risk operations, providing enhanced operator and product protection.

Our containment strategy is risk-based and tailored to the specific molecule and process, ensuring the right level of protection from laboratory development through manufacturing.

Built for Safe, Scalable Manufacturing

Our HPAPI facilities combine engineered containment, dedicated HVAC and HEPA-filtered air systems, controlled personnel access, and dedicated manufacturing teams to provide a robust platform for high-potency molecule development and manufacturing.

From early-stage clinical development to commercial supply, our HPAPI CDMO capabilities are built to deliver potency, safety, quality, and scalability at every stage.

HPAPIs Production Operations

S.No Facility / Infrastructure Considerations Remark
1 Designated Area with Access Control Designated Area with Restricted Access
2 Pressure Gradients Monitoring of the air pressurization system and failure alert
3 Air Changes per hour (AC/h) 15 – 20 AC/h typical
4 Air Recirculation and % of Fresh Air (% FA) 100% FA (100% Once-through) or 10% fresh air with recirculation
5 HEPA filters on Outlet / Return Air HEPA Filters available
6 Personnel Air Lock Available
7 Separate Gowning and Degowning Areas Available
8 Material storage area Designated area is available
9 Maintenance and Spills Special Attention to Maintenance Personnel Protection
10 PPE Full Protection (PAPR / Airline Respirator, Tyvec suit, Double Gloves, etc.)
11 Waste disposal Collect, Contain, Label and Treat (if applicable) and dispose appropriately
S.No Containment Control / Engineering Matrix Remark
1 Dispensing / Weighing – Wet Powders Isolator with contained transfer ports
2 Dispensing / Weighing – Dry Powders Isolator with contained transfer ports
3 Charging / Feeding - Wet Powders Appropriate contained transfer technology, direct connection between processing units or Isolator
4 Charging / Feeding - Dry Powders Appropriate contained transfer technology, (e.g. PTS, DCS, etc.), direct connection between processing units or Isolator
5 In-process Sampling On-line dedicated sampling system is available
6 Filtration AGNFD with isolator
7 Drying AGNFD with isolator and VTD with isolator. Use of isolator for loading and unloading or change drying technology
8 Milling / Micronization / Sifting Isolator
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