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Novo Nordisk Pharmatech MD says quality is now key differentiator
Koege, Denmark: – World-leading insulin specialist Novo Nordisk Pharmatech A/S now sees quality as the key differentiator and competitive edge in international pharmaceutical markets.
This is one of the key points made by Novo Nordisk Pharmatech Managing Director and Corporate Vice President Rasmus Hother le Fevre in the lead article in the current issue of Pharma Focus Asia magazine.
Mr. Hother le Fevre says formally documented quality assurance (QA) has become the key market differentiator for almost all products and services in highly competitive pharma markets.
“Quality control is essential to building a successful business that delivers products that meet or exceed customers’ expectations. It also forms the basis of an efficient business that minimizes waste and operates at high levels of productivity,” he notes.
Novo Nordisk Pharmatech now works constantly on enhancing product quality, encouraging regular audits by pharmaceutical companies as well as inspections by the Danish Medicine Agency., while complying with ISO 9001, ISO 14001 and other quality standards.
He points out that while quality control (QC) is a product-oriented process that ensures the end product meets the quality requirements, QA is a process-oriented practice that guarantees the manufacturing process.
“Therefore, quality assurance can be identified as a proactive process, while quality control can be noted as a reactive process,” says Hother le Fevre.
He says controlling quality by utilising product inspections throughout the production cycle reduces sourcing risks and cost and ensures high quality.
“A good plan is only as good as its foundation, so comprehensive and detailed product specifications are critical to success. An important component of product quality is knowing your product. And, that requires detailed product specifications that identifying exactly how the item(s) should turn out,” he says.
This strategy is Novo Nordisk Pharmatech’s response to what it sees as huge future challenges facing the pharmaceutical/healthcare markets.
“Big legislative and regulatory changes are coming to the industry. There is an increase in regulatory expectations from Innovators and generics to be able to guarantee patient safety due to today’s expanding global market,” notes Mr. Hother le Fevre.
He says pharmaceutical industry quality functions are struggling to keep up with the rising demands of regulators, with increasing relevance of global markets beyond North America, Europe and Japan adding complexity of multiple quality standards and regulatory regimes.
“Compliance, robustness of processes, and efficiency will need to be squared in one equation. That is the reason why we need to be at the very forefront when it comes to meeting the industry standards and ensuring patient safety,” says Hother le Fevre
“Our definition of success has not changed; we still want to maintain the position of market leader and innovator in the industry. We aim to be the best supplier of pharmaceutical ingredients by providing excellence at every step of the supply chain – beginning with a consistent high quality of our products, ensuring continuous availability and a secure global supply chain, to an extensive regulatory documentation living up to the highest available standards,” he says.
“By delivering excellence at every step, we help our customers do the same – whether they’re developing a cure for cancer or a new ophthalmic. We deliver a proven record of product purity, reliability and consistency and can even tailor products for future therapies. We help keep development on track and production flowing for hospitals and patients,” says Hother le Fevre
Mr. Hother le Fevre also emphasizes the benefits of using cGMP Quaternary Ammonium Compounds (Quats) such as Benzalkonium Chloride, Cetrimide, Cetrimonium Bromide (CTAB) and a range of others as excipients in topical, nasal and ophthalmic applications, either as preservatives or active ingredients. They can also be used as lysing or precipitating agents in vaccine production.
“FeF™ Quats are effective at all pH levels. However, their effectiveness increases when the pH increases. The higher the pH, the lower the concentration needed to obtain an antimicrobial effect. As opposed to bacteriostatic/fungistatic compounds which only prevent micro-organisms from dividing (growing), Quats are bactericidal/fungicidal meaning they will kill microorganisms whether they are in a growth phase or not.
“Our production and process know-how allows us to offer Quats with a completely well-defined alkyl chain length distribution, whether it is with our standard chain length or with customized chain length distributions. Our customers also receive a regulatory package, which will help the approval process of their product when using FeF™ BKC,” notes Mr. Hother le Fevre.
Rasmus Hother le Fevre
Rasmus Hother le Fevre, Managing Director (Corporate Vice President), Novo Nordisk Pharmatech A/S, began his career with Novo Nordisk A/S as a Production Planner in 2000. In 2003 he became the head of Shipping and Customer Service and in 2004 he took up the role as Director for the purification plant responsible of purification of Insulin Levemir and Insulin Aspart.
In 2006 Mr. Hother le Fevre was appointed Corporate Vice President heading up the purification plants and in 2010 relocated to Zürich as Global Marketing Director head of Victoza® Launch Execution Team. In 2012 he became the Managing director & Corporate Vice President at Novo Nordisk Pharmatech A/S.
About Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S was established in 1949 as FeF Chemicals, acquired by Novo Nordisk in 1986 and has been part of the pharmaceutical group since then. Novo Nordisk Pharmatech A/S is the leading worldwide supplier of recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds (quats) for the pharmaceutical, biopharmaceutical industry.
Click on Pharma Focus Asia to see full article.