High Potent Oral Solid Dose (OSD) Manufacturing Services

Oral solid dose (OSD) drug product manufacturing with highly potent active pharmaceutical ingredients requires an adequate working environment, strict manufacturing protocols, and a workforce trained to handle highly potent products. 

High potent OSD projects

Each high potent OSD drug project begins with a risk assessment, which considers the entire manufacturing process, from sampling, dispensing and manufacture through to the finished, packaged and analyzed product. The assessment consists of examining any risks that may arise, and the extent of the immediate danger for users, workers and the environment. 

How Recipharm supports your success:

• Seamless tech-transfers that keep timelines on track
• Proven processes to manage potent and sensitive compounds
• Flexible batch sizes to fit your development and supply needs

Manufacturing highly potent drugs in-house

The manufacture of high potent products requires highly technical expertise, technologies and containment facilities. Recipharm have both the infrastructure and processes in place to deliver your High Potent project, from clinical all the way trough to commercial

• Closed systems, isolators, ventilated enclosures, split butterfly valves, and local exhaust ventilation ensure containment
• Pressurised zones, single-pass air, high air change rates, safe-change filters, airlocks, and misting showers minimise cross-contamination
• QC performed in segregated rooms with airlocks and independent HVAC (H13 filtered, no recirculation)
• Laminar flow cabins used during product exposure (e.g. sampling)
• PPE includes chemical suits, hoods, PAPRs, and gloves; personnel access is restricted and health-monitored
• QA systems ensure facilities, equipment, and procedures meet containment requirements
• Hazardous waste managed under special containment conditions
• Cleaning validation based on API characteristics, with sampling under containment

Navigating the complexity of HPAPI manufacturing

Manufacturing of high potent OSD products demands adaptability but also investment in containment controls at production sites. 
Recipharm offer adaptability and strategic decisions towards flexible small-volume operations.
 

Partner with Recipharm for your HPAPI manufacturing

Need assistance with your HPAPI  or high potent OSD project? Recipharm is your trusted CDMO partner to help  navigate the evolving landscape of high potent OSD manufacturing. Contact us below for all your clinical to commercial needs.