Organon - Pharmaceutical and Biopharmaceutical Drugs and Ingredients

Organon is an ideal partner in pharmaceutical manufacturing and development services, offering exceptional technical capabilities, experience and infrastructure. The manufacturing business development – also known as Organon Pharmaceutical Services – offers manufacturing of drug products to third parties (insourcing), and is part of the global manufacturing organisation of Organon.

Organon Pharmaceutical Services concentrates its main activities on the sites at Gisors (France), Oss (Netherlands) and Swords (Ireland), but also supports insourcing activities at the other Organon manufacturing sites worldwide.

ORGANON'S DRUG-PRODUCT SERVICES

Organon supplies the following drug-product services:

• Tabletting
• Caps
• Suppositories
• Ampoules (solution and lyophilized)
• Vials (solution and lyophilized)
• Bottles
• Syringes
• Creams
• Implants moulding
• Implants filling in ampoules
• Implants filling in vials

ORGANON'S DRUG-MANUFACTURING COMPATIBILITIES

Organon produce a range of standard APIs including classical small molecules.

Our capabilities in biotechnology include recombinant proteins, carbohydrates, ribonucleic acids, peptides and antibodies

We also produce special environment products such as hormones and highly-active compounds, and CGMPs such as EMEA, FDA and Japanese cGMP.

BIOTECHNOLOGY PARENTERAL CAPABILITIES

• Vial types: 2 / 6 / 10 / 25 RDIN and 50ml
• Stoppers: 13mm and 20mm, and freeze-dry / solution
• Fill volumes: vials - 0.5ml to 50ml
• Batch size: 1L to 1,000L
• Aseptic process with lyophilization

Organon considers manufacturing for third parties a strategic decision, and is committed to the following:

• Delivery of promises
• Open communication
• Proven expertise
• Teamwork
• Access to 'A-class' technology

DEVELOPMENT, REGISTRATION AND PRODUCTION OF SAFE MEDICINES

Our advanced facilities and highly-trained employees provide outstanding quality in studies, activities, processes and products. It is our belief that quality is the assurance of the successful development, registration and production of safe medicines. Quality is also vital in order to meet government standards.

MINIMISATION OF PHARMACEUTICAL-RELATED RISKS

Safety training and adherence to the strict safety-standards of Organon ensure compliance with regulations and minimisation of risks. At all stages of manufacturing, special attention is paid to HSE aspects, especially issues such as occupational health, ergonomics, workload, incidents and accidents, RSI, waste management, energy consumption, and risk assessment.

Programs for the systematic measuring of possible exposure to hazardous materials help to minimise the risks faced.

A RELIABLE PARTNER FOR HEALTHCARE PROFESSIONALS

As Organon is dedicated to reliable, on-time delivery of services, punctuality is a priority. Our objective is to remain a reliable partner for healthcare professionals by committing ourselves to delivering as promised; not only because we have to preserve our reputation, but also because this is particularly embedded in our way of working.

At Organon, meeting our individual commitments is an integral part of our culture. We take full responsibility for our actions and their outcomes.

BROAD RANGE OF PHARMACEUTICAL SERVICES

We can offer a broad range of services, ranging from formulation development, stability investigations, process development and analytical development, to qualification and scale-up, through manufacturing and packaging of products, to support clinical trials and commercial sale.

Organon's pharmaceutical services include:

• Extractable, leachable study for the primary package
• Quality-control test and release of raw materials, package components and labels
• API process qualification, protocol and report, and sample taking
• Validation of microbiological methods' sterility and LAL
• Development of analytical methods
• Holding time studies of the bulk solution
• Formulation development
• Filter validation
• Manufacturing-process optimisation
• Media fill, including container closure integrity testing
• Freeze-drying cycle / autoclaving cycle development
• Stability studies

Organon offers over 80 years of experience in developing and manufacturing biopharmaceutical and pharmaceutical products.

ACTIVE PHARMACEUTICAL INGREDIENTS AND BIOPHARMACEUTICAL PRODUCTS

Organon and its affiliates have been world-leading manufacturers of active pharmaceutical ingredients since 1923. We help pharmaceutical and biotechnology companies around the world go from process to protein. Organon can also provide 'classical' APIs, as well as contract process development and cGMP manufacturing services for biopharmaceutical products from pre-clinical trials to market.