OSD
High potent oral solid dose (OSD) manufacturing
Recipharm, your high potency partner that delivers, from clinical phases to market.
Recipharm accelerates your high potency journey, combining speed, reliability and regulatory excellence. With state-of-the-art containment facilities and scalable capacity, we help pharmaceutical companies bring potent oral solid doses from clinical phases to commercialisation faster, without compromise on safety or compliance.
High potent OSD projects
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.
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 analysed product. The assessment consists of examining any risks that may arise, and the extent of the immediate danger for users, workers and the environment.
Why partner with Recipharm
For every project, we start with a data-driven risk assessment, powered by our predictive, proprietary tool ReciPredict®, ensuring de-risked tech transfers and on-time milestones.
- Seamless tech-transfers: with statistical modelling and simulation to keep timelines on track
- Reliable delivery and quality: averaging 93% on time delivery and 95% right first-time performance across our network
- Proven processes: to manage potent and sensitive compounds
- Flexible batch sizes: to fit your development and supply needs
- Transparent project dashboards: to keep you in control
Manufacturing highly potent drugs in-house
The manufacture of high potent products requires highly technical expertise, technologies and containment facilities. Recipharm has both the infrastructure and processes in place to deliver your high potent product project, from clinical all the way through to commercial
Our facilities are designed to meet high containment standards (up to OEB 5), combining cutting-edge technology with rigorous QA and safety systems
Containment systems: closed systems, isolators, ventilated enclosures, split butterfly valves, and local exhaust ventilation ensure containment
Facility containment: pressurised zones, single-pass air, high air change rates, safe-change filters, airlocks, and misting showers minimise cross-contamination
Segregated QC: dedicated rooms with airlocks and independent HVAC (H13 filtered, no recirculation)
Controlled exposure: Laminar flow cabins used during product exposure (e.g. sampling)
PPE: chemical suits, hoods, PAPRs, and gloves; personnel access is restricted and health-monitored
QA systems: ensure facilities, equipment, and procedures meet containment requirements
Waste and cleaning control: Hazardous waste managed under special containment conditions. Cleaning validation based on API characteristics, with sampling under containment.
FACT SHEET | Scalable solutions for high potent manufacturing
INSIGHT | Navigating high potency manufacturing
Navigating the complexity of high potent manufacturing
Manufacturing of high potent OSD products demands adaptability as well as investment in containment controls at production sites. Recipharm offers adaptability, with flexible small volume operations, and scalable capacity, enabling customers to progress from early development to commercial supply in confidence.
FAQs - Frequently asked questions
Recipharm combines:
- Containment up to OEB 5
- ReciPredict™ risk-based planning for predictable milestones
- Seamless tech-transfer with modelling & simulation
- Flexible batch sizes and scalable operations
- Network wide reliability and regulatory excellence
- Integrated services from formulation through packaging
This ensures a smooth journey from molecule to market.
Our facilities operate up to OEB 5, supported by closed systems, advanced isolators, controlled exposure units, segregated QC, and dedicated HVAC infrastructure. This ensures safe and compliant manufacture of even the most potent solid dose products.
Every project starts with a risk assessment. We assess exposure risk across every stage, sampling, dispensing, blending, compression, packaging and testing, to define the appropriate containment strategy. This process is supported by our data-driven approach with our proprietary ReciPredict™, ensuring seamless tech-transfer and on-time execution.
Yes. Recipharm provides fully scalable solutions, from early phase development through to commercial supply. Our flexible batch sizes, adaptable production lines, and robust containment infrastructure allow customers to progress smoothly from small-volume clinical batches to large scale commercial production.
Across our network, we achieve 93% on-time delivery and 95% right-first-time performance. This is enabled by:
- Proven high-potent handling processes
- Seamless tech-transfer supported by statistical modelling
- Transparent project dashboards
- Rigorously validated equipment and QA systems
Yes. Recipharm provides end-to-end services including formulation development, technology transfer, packaging, analytical support, regulatory expertise and new product introduction (NPI). This allows customers to streamline suppliers and accelerate timelines.
Related services
Our integrated network of experts ensures trusted speed across every stage, from formulation to packaging.
Oral solid dose experts in OSD manufacturing including powder, granule, tablet and pellet formulations
Technology transfer support in seamless transition of data, materials and knowledge
ReciPredict™ accelerating process development and technology transfers
Recipharm, your trusted CDMO partner
Looking for reliable support on your high potent OSD project? Partner with Recipharm to simplify high potent OSD manufacturing, get in touch with our team today.
