Democedes Pharma and IMA Active: ensuring safety, quality and compliance in highly potent drug manufacturing.

Introduction

Democedes Pharma was established in 2016 with the mission of addressing the growing demand for oncology treatments while ensuring continuity of supply and maintaining pharmaceutical quality at every stage of production. Following the receipt of site operation authorisation in March 2022, the company started pilot batch manufacturing, culminating in the successful completion of its first process validation batch in July 2023, a key milestone confirming both industrial and regulatory readiness.

What sets Democedes Pharma apart from other pharmaceutical companies is its fully in house development model. Unlike companies that rely on technology transfers, Democedes Pharma develops its formulations internally, and bio equivalence studies are conducted on proprietary products.

This approach ensures full ownership of the product development process, deep understanding of manufacturing and formulation parameters, and enhanced control over critical quality attributes. Together, these ensure both innovation and consistency in the final product.

The company operates with significant production capacity, including 40 million tablets, 20 million capsules and 2.7 million injectable vials per year, comprising solution and lyophilised dosage forms. Product distribution is ensured through two strategic channels: a pharmaceutical wholesaler serving the private market and the Central Pharmacy of Hospitals supplying the public hospital sector through national tenders. Democedes Pharma’s primary focus is the development and manufacture of highly potent drugs (HPAPI), with a strong specialisation in oncology. Supported by a robust Pharmaceutical Quality System aligned with US FDA GMP, WHO GMP, and EU EMEA GMP, the company operates in full compliance with international regulatory expectations while prioritising the national market in line with supply security and self sufficiency requirements.

At IMA Active, we believe that excellence in pharmaceutical manufacturing starts with safety. As the demand for high potency drugs continues to grow, containment has become a cornerstone of modern production. Our collaboration with Democedes Pharma reflects this shared commitment. Together, we have implemented a fully contained production line designed to ensure maximum protection for operators, the environment and the product itself. From granulation to capsule filling, tableting, coating and product handling, containment is at the core of every operation, supporting efficiency, compliance and the highest quality standards. Thanks to IMA’s advanced technologies, Democedes Pharma not only meets the most stringent international regulations, but also sets a new benchmark for safe and reliable high potency drug manufacturing.

What is the primary focus of your business, and how does it differentiate itself from competitors?

Our primary focus is the development and manufacture of highly potent drugs, with a strong specialisation in oncology. We differentiate ourselves through a fully integrated in house development model: formulation development, process optimisation, scale up and bio equivalence studies are conducted on proprietary products.

This integration secures tight control over critical process parameters and CQAs – an essential requirement when dealing with highly potent substances.

To sustain this model on the shopfloor, we rely on equipment designed for high containment operations. For example, at the granulation stage we use ROTO CUBE, an all in one single pot solution. ROTO CUBE performs wet granulation and vacuum drying, ensuring in-containment processing inside a sealed bowl, that minimises product transfer and open handling, an approach intrinsically suited to HPAPI manufacturing.

How does your company fit within the broader pharmaceutical industry, and what are the key markets you serve?

We operate within a highly regulated segment of the pharmaceutical industry, focusing on HPAPI based products for oncology. Our current strategic priority is Algeria’s national market, aligned with regulations emphasising internal supply security and pharmaceutical self sufficiency before export authorisation.

At the same time, our Pharmaceutical Quality System and documentation are designed to meet international regulatory expectations (US FDA GMP, WHO GMP, EU EMEA GMP), positioning the company for future expansion into international markets.

What are the main challenges when handling highly sensitive products, and how does your company address them?

Handling highly potent drugs presents significant challenges across three key areas: product quality, operator safety and environmental protection. Manufacturing in confined and controlled environments leaves no margin for error and requires highly skilled personnel with strong expertise in material handling, substance behaviour and critical process parameters. To address these challenges, we have implemented isolator technology across key processing steps, ensuring robust physical separation between operators and products. Our operations are aligned with sustainable development principles: strict environmental controls, controlled effluents and waste management, and continuous monitoring by a dedicated HSE team.

On equipment, in process controls for weight, hardness, thickness and capsule filling are embedded directly into compression and encapsulation units, enabling automatic real time parameter adjustments that reduce human intervention and error risk, thereby supporting consistent, reproducible quality.

Could you describe the containment process on your production line and the role of IMA technologies?

IMA technologies play a key role in enabling this approach, with solutions providing flexible parameter control, robust containment and enhanced operator protection. Together, these features support workforce safety, maintain process integrity and ensure reliable, compliant production of highly potent pharmaceuticals. Containment is a fundamental element of our manufacturing strategy, especially when working with highly potent products. For this reason, each step of the process is carried out using technologies designed to maintain a closed, controlled environment while ensuring process efficiency and product quality.

Throughout the line, from granulation to capsule filling, compression, coating and material handling, we rely on equipment engineered to operate in isolation and to minimise open product contact.

For example, granulation is performed with ROTO CUBE, a single pot granulator, which allows mixing, wet processing and drying to take place within the same sealed bowl, greatly reducing transfers and exposure. During encapsulation and tableting, we employ systems integrating dedicated separation between the process areas and the mechanical components, together with in process controls that adjust critical parameters automatically, reducing operator intervention to the minimum necessary.

The same containment philosophy applies to coating operations, where cleaning cycles and air management are optimised to avoid particulate dispersion, and to powder blending, which takes place directly inside hermetically closed bins to prevent cross contamination and limit the number of handling steps. Across all stages, IMA Active technologies support a manufacturing model in which safety, consistency and process integrity are preserved without compromising efficiency. The result is a production environment that aligns with international expectations for HPAPI processing and ensures reliable, reproducible quality throughout the workflow.

Your production line has been validated by an independent international organisation. What does this validation cover?

The containment systems and equipment in our production line have been validated by SGS, a globally recognised leader in certification, qualification and metrology. The validation protocols ensure compliance with internationally recognised standards for process containment, operator safety and product quality. IMA’s automated and reliable technologies were integral to meeting these stringent requirements by minimising manual intervention while maintaining the highest safety and compliance standards.

What does this international certification mean for your customers and stakeholders?

For customers and stakeholders, this validation represents a strong guarantee of safety, quality and regulatory compliance. It confirms that our manufacturing processes are robust, controlled and aligned with global best practices. Working with IMA further strengthens our reputation in the pharmaceutical industry, demonstrating our commitment to innovation, employee safety, and the consistent delivery of high quality oncology products.