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Wednesday, December 7, 2022
Home Pharma & Biotech Contract Manufacturing Organisation Fresenius Kabi’s Growing Contract Manufacturing Business

Fresenius Kabi’s Growing Contract Manufacturing Business

By Erin Gotthelf, Business Development Manager, Fresenius Kabi

Fresenius Kabi employs around 40,000 people worldwide. In 2021 the company reported sales of more than € 7 billion. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as medical devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. Within transfusion technology, Fresenius Kabi offers products used in the collection and processing of blood and cell components, as well as in transfusion medicine and cell therapies. The company is committed to putting essential medicines and technologies in the hands of people who help critically and chronically ill patients and finding the best answers to the challenges they face.

Fresenius Kabi Contract Manufacturing provides partners access to the expertise of more than 20 manufacturing sites and worldwide, specializing in the fill/finish of sterile solutions and emulsions in Non-PVC and PVC IV-bags, bottles, vials, ampoules and pre-filled syringes in both glass and plastic. Pre-filled syringes allow for self-administration through an auto injector and can come equipped with a needle safety device. These global capabilities lead to best practices via idea sharing and the sites operate in strict conformity with international quality standards (FDA-GMP, EU-GMP, cGAAP, WHO-GMP, Medical Device Regulations).

New products are evaluated by means of an initial feasibility study in which client (location, required services) and product (process requirements, product size, markets) are carefully compared to facility (location, on-site technology and support toolbox versus) before a selection is made for a customer program. Fresenius Kabi pairs customers who require engineering and development work with its pilot plants to perform compatibility studies, process optimization, and scale-up work. Fresenius Kabi utilizes dedicated project managers and in-house analytical testing to drive transfer projects through to commercialization.

Manufacturing capabilities include aseptic processing in isolators on automated, closed systems, terminal sterilization, and lyophilization of drug products. Terminal sterilization capacity is a key offering for diluent supply, while lyophilization processing is a key offering to maximize the shelf life of products by minimizing unwanted reactions. Fresenius Kabi can also manufacture solutions and disperse systems such as microparticles, emulsions, suspensions, and liposomes. These highly potent drugs are ideal for patients but difficult to manufacture. Building containment into the process via dedicated tanks, disposable bags, and single-use filling systems allows Fresenius Kabi to produce products for customers that have an OEL of less than 10 µg/m3 while eliminating the risk of cross-contamination. Subject matter experts have developed process flow and training procedures that enable safe handling of these compounds.

On the medical device side, Fresenius Kabi produces custom engineered transfer sets for its containers, which can utilize double-sided plastic needles or micro spikes with needle-free luer lock syringe connections based on customer requirements.

The company is focused on high throughput projects andhas capacity to supply billions of units annually based on billions of dollars in investments in high-volume capital equipment for the manufacturing plants. Experienced technology transfer and quality teams are in place to provide the technical, system, and regulatory support needed to efficiently commercialize each unique drug product.

 

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