Novo Nordisk Pharmatech improves biopharmaceutical manufacturing by developing and supplying innovative products used in the manufacturing of biopharmaceuticals. Biopharmaceuticals are medicines based on biological molecules, such as insulin, growth hormone and blood coagulation factors.

In this way, Novo Nordisk Pharmatech improves biopharmaceutical manufacturing – and makes biopharmaceuticals cheaper to produce, thereby enabling better access to medicine for patients.

A wide range of capabilities are available at Novo Nordisk Pharmatech within the various departments: Sales and Marketing, R&D, Manufacturing, Quality, Business Support and People & Organisation. All capabilities present in the company are critical for Novo Nordisk Pharmatech to run the business and innovate.

The following “Core Capabilities” are those that stand out as unique to Novo Nordisk Pharmatech, and are fundamental to the future growth of the company:

• Designing and developing silica gels: Novo Nordisk Pharmatech has a long history of continuously reducing the cost for Novo Nordisk of producing insulin by providing robust silica gels and developing processes for increasing their lifetime.
• Advanced microanalysis: At Novo Nordisk Pharmatech’s Microanalysis Centre, a highly skilled team supports Novo Nordisk with state-of-the-art microscopy and spectroscopic support. This capability is also critical for the development of new chromatographic resins.
• Organic chemical synthesis manufacturing: Novo Nordisk Pharmatech has, from the outset, produced Quats by organic synthesis manufacturing and has gained solid experience within the field.
• cGMP embedded throughout the organisation: Biopharmaceutical companies are required to operate in accordance to cGMP in order to ensure patient safety. For Novo Nordisk Pharmatech to be a preferred supplier to the biopharmaceutical industry, cGMP is therefore a key capability.

Novo Nordisk Pharmatech’s R&D pipeline comprises several new products under development. Every new product goes through the four phases:

1. Idea phase, where the potential value of the product is analysed
2. The R&D phase, where the product is developed in the lab in close collaboration with customers
3. The tech transfer phase, where the technology is transferred to production and the production facility is built
4. The launch phase, where the product is introduced to the market

We ensure high quality in our products by meeting the expectations and needs of our stakeholders. We strive for simplicity and never compromise on quality.

The development of new products is based on the requirement from the customers and the final use of the product. Quality by design is used during development to ensure that quality is built into the product, with a high focus on product and process understanding, as well as on process control as opposed to relying on testing of the final product.

From development through tech transfer to production, our Quality Management System (QMS) ensures that knowledge is handed over, thereby ensuring that employees understand both why and how to ensure quality.

It is part of our strategy to safeguard product quality and compliance, thereby safeguarding the patient.

Our QMS is based on ISO 9001 and covers processes from development to post-delivery activities. We strive for simplicity and we develop and maintain a process-oriented QMS based on our stakeholders’ expectations, as well as legislation and requirements from authorities, eg “EU GMP vol. 4 part II”, “ICH Q7” and “The Joint Good Manufacturing Practices Guide for Pharmaceuticals Excipients”.

The drug substance production is inspected by the Danish Medicines Agency on a regular basis and we are also inspected by the FDA. Audits from our customers are part of our quality agreements with them. Historically, the results of these inspections and audits have shown a very high level of compliance.