Pharma Insight Briefings

Area of presentation – ICSE General Contract Services - Contract Manufacturing Services for Pre-filled Syrings – from Standard  Solutions to Complex Products

Speaker Name: Mr. Stefan Czvitkovich, PhD - Speaker Job Title:  Director PP Sterile Pharmaceuticals Central Europe

  1. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?

Attendees can gain insight into the manufacturing capacities and capabilities Fresenius Kabi provides for contract manufacturing in the US and in Europe. With its capabilities, Fresenius Kabi can provide services from standard solutions to complex products, from early development to commercial manufacturing, and from standard to customized processes.

2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?

For contract manufacturing, innovative and expensive products on a small batch scale pose significant challenges for technical implementation. There is increasing demand for the manufacturing of biosimilars, biologics, or products with complex formulations from early clinical phase to commercial production. Two key aspects are 1) the definition of the key quality attributes and process parameters to implement a robust and scalable process, and 2) the optimization of the commercial process to avoid product loss. Fresenius Kabi covers these different areas via given its customers access to its development know- how and facilities to implement robust manufacturing process and has also a high degree of technological flexibility to implement also customized processes depending on the product requirements. Besides, Fresenius Kabi has significant experiences with clinical batch manufacture and supports customers from early development until commercialization.

3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?

Pre-filled syringes provide a dosage system for expensive liquid drug products that maximises the yield of product during manufacture and also adds additional convenience to application. As such, pre-filled syringes are a container closure system of choice not only for standard solution but also complex formulations and biologics.

4. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?

Attendees can gain insight into the manufacturing capacities and capabilities Fresenius Kabi provides for contract manufacturing in the US and in Europe. With its capabilities, Fresenius Kabi can provide services from standard solutions to complex products, from early development to commercial manufacturing, and from standard to customized processes.

5. How do you see your sector of the market evolving in the next 5 years?

Both the sector for contract manufacturing of sterile liquids and more specifically for pre-filled syringes will continue to grow further over the next 5 years. Hence, more competition is expected to be on the market and the need to provide services at the highest quality with competitive time lines will remain vital to be differentiated from other CMOs.