Industry 4.0 Solid Dosage Manufacturing Plant, Pfizer, Freiburg, Germany

The Pfizer pharmaceutical solid dosage manufacturing plant located in Freiburg, Germany is one of the largest in the world covering a total area of 155,000 m2. Backed by Pfizer resources, the facility offers access to the same expertise and state-of-the-art technologies that Pfizer uses to deliver its breakthroughs.

The Pfizer pharmaceutical manufacturing site in Freiburg, Germany is a partner site for Pfizer CentreOne and offers access to leading oral solid capabilities, innovative manufacturing technologies and collaborative problem-solving.

Manufacturing approx. 4.5 B tablets and capsules every year

The site manufactures approximately 4.5B tablets and capsules yearly, supporting millions of patients around the globe. Therapeutic expertise includes oncology, cardiovascular diseases, neurological disorders, rheumatology, and pain management.

Through its Pfizer CentreOne CDMO services, the site can provide expertise in oral solid process and product development, flexible volume manufacturing, leading packaging technologies and global delivery. Pfizer CentreOne has served as a CDMO for over 10 years and has extensive experience of successful tech transfers both within Pfizer and through partnerships. The manufacturing site has distinguished itself as one of the most innovative future-oriented and digitally-enabled pharmaceutical manufacturing sites in the world offering solutions to most complex oral solid challenges.

Manufacturing capabilities include:

• Annual manufacture of 200+ product formulations and 3,500 SKUs
• End-to-end product and process development from lab and pilot scale to full manufacturing scale
• Flexible production that allows both small and large volumes, meeting a wide range of partner requirements
• Pfizer quality standards; 20 percent of employees dedicated to product quality
• Robust Manufacturing Excellence process to ensure best performance every time
• Reliable global delivery to more than 150 markets including Japan
• Pfizer’s Packaging Center of Excellence with 241M packs produced in 2019

Industry 4.0

Digitally enabled pharmaceutical production technology including:

• Industry 4.0 digital processes and state-of-the-art-technologies
• Computer integrated manufacturing
• Fully automated process and material flow
• Electronic batch records
• Continuous manufacturing technology (CMT)
• High containment facility for production of highly potent and controlled drugs to open in 2021

Offers a full spectrum of solid dosage forms

The Freiburg manufacturing site offers a full spectrum of solid dosage forms through fast, agile, and innovative supply solutions. All material movements are fully automated, facilitating a flexible connection of each manufacturing step. As a result, any manufacturing sequence can be programmed and executed. For instance, extrusion or wet granulation can be followed by encapsulation or compression.

The fully automated transport system ensures the continuous workflow between production steps. Combined with our fully flexible automated manufacturing processes, this lays the foundations for high efficiency and complexity handling. Automation allows for a multitude of different products to be manufactured at the same time. Freiburg has a full range of OEB 1-5 engineering controls for development and commercial supply.

High Containment for Development Services (DevCon)

This cGMP-compliant, OEB 4/5 facility manufactures clinical supplies (phase 2B to 4) and includes all process steps to produce tablets, film-coated tablets and capsules.

The latest addition to the Freiburg site is a high containment facility planned to open in 2021. Implementing latest technology in automated dispensing and weighing processes, the facility expands the site’s high containment offer in OEB 4/5 and provides the level of expertise and capacity required to respond to partner challenges in highly potent oral solids. The facility is designed to meet a range of partner demands and features high volume and flexible volume suites, with small-scale production starting at just 30kg. The area is equipped to produce tablets, film-coated tablets and capsules. Analytical capabilities include real-time release and NIR process analytical technology for blending and content uniformity. The facility equipment meets industry 4.0 standards and is certified for energy efficiency and sustainability through Leadership in Energy and Environmental Design (LEED) program.

Continuous Manufacturing Technology (CMT) and Portable Continuous Miniature and Modular (PCMM) Manufacturing

These innovative, next gen technologies allow for continuous processing and greater flexibility. CMT has proven to increase efficiency and quality of production. The process is made possible by a proprietary Pfizer technology called continuous mixing. With the technology, a specially designed mixing unit can blend active ingredients into a homogeneous compound without interruption. The process saves time and money, and reduces the possibility for error. PCMM comprises a network that integrates a small footprint, continuous processing equipment, smart control systems and PODs (portable, self-contained GMP modules) to process API powders and inactive ingredients into bulk tablets. Production materials arrive through a fully automated feeding system; this and the Pfizer developed mixing technology ensure high homogeneity and uniformity. New measuring methods constantly check the quality during ongoing production in real time. This selfcontained and fully automated process allows Freiburg to further increase production flexibility and accelerate scale-up.

Packaging capabilities

Freiburg has one of the highest packaging volumes for a pharmaceutical manufacturing facility, with 241M packs produced in 2019. It is the Center of Excellence for blister and bottle packaging, which are delivered through flexible and high-speed technologies ensuring quality and speed to market. The plant can also handle highly potent products, controlled drugs and immunosuppressants in specially designated containment packaging areas.

Equipment includes modern flexible packaging technologies such as Packaging on Demand and Blister Express Center, which coupled the high-speed packaging solutions can meet a wide range of partner specifications with packaging lot sizes ranging between 1 and 1,000,000. Highly automated processes such as material flow, palletizer robots, computer integrated manufacturing, and 100% electronic batch recording ensure the ability to handle complexity and meet partner timelines.

With regulatory approvals for all markets including the U.S., China and Japan, Freiburg can meet all global aggregation and serialization requirements.

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