Sterile Injectables

An Exact SI-ence

Pfizer CentreOne is a leading global CDMO dedicated to unlocking the potential of your sterile injectable. Time is life, and in the rapidly evolving sterile injectable space, expertise is key to helping ensure the safe, successful delivery of your innovative therapeutic to the patients who need it.

As an experienced partner with an uncompromising commitment to quality, flexibility and transparency, we can help you skilfully maneuver through complexities, keeping pace with both scientific advancements and regulatory requirements.

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Expert content

Explore our infographic to discover how we navigate the intricate sterile injectable landscape

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In this application note we examine key considerations for the development and manufacturing of your unique sterile injectable

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Discover how Pfizer CentreOne can help deliver high quality sterile injectable therapeutics

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Discover how successful CDMO collaboration sets the foundation for sterile injectable product success

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Why choose Pfizer CentreOne for your sterile injectables?

Expansive expertise and specialized capabilities

  • Decades of sterile injectable experience delivering the exact science required to meet the unique needs of projects around the world
  • Support for the formulation of injectables, complex sterile injectables delivery mechanisms and therapeutics including antibody - drug conjugates (ADCs), novel vaccines,and gene and cell therapies
  • Sites specialized in meeting various production needs — from small volume to large volume, varying complexity and highly potent compounds
  • Development support team with regulatory intelligence for more than 150 countries

 

Reliability and quality, delivered at speed

  • We’re here to help, every step of the way - from clinical to commercial
  • A strong reputation for quality and meeting regulatory requirements at key milestones
  • Robust processes developed and optimized to ensure speed and consistently high quality
  • Safeguarding sterility and safety with specialized automated and digitized technologies including automated loading and unloading, single-use technologies and integrated lyophilizer and fill lines
  • Supply chain reliability to help ensure safe and secure delivery of key medicines
     

A flexible and transparent partner

  • We’re here to help, every step of the way — even when the unexpected happens
  • Facilities designed and processes optimized with integration in mind to enable “lightspeed” principles and help prevent delays
  • Transparent communication enabled through robust protocols for data sharing in real time
  • Flexibility in packaging with a wide range of vial sizes, liquid and lyophilized filling, pre-filled syringes (PFS), cartridge capabilities, and full serialization and  traceability
  • Continuously improving through new technologies and sites to anticipate
  • future needs
     

Overcoming challenges in sterile injectable formulation development

We’ve helped our customers find solutions to many technical hurdles over the years. We can help you do the same. Our experience in the field allows you to negotiate development pitfalls, including:

  • Unexpected interactions between API and container closure systems
  • Dependence on hard-to-procure commodities that could threaten launch timelines
  • Impediments to scale-up, such as rapid compound degradation
  • Uncommon or unidentified impurities in the API

More from development

Our sterile injectable manufacturing expertise

Pfizer CentreOne has access to best-in-class manufacturing and development facilities around the globe. No matter where in the world you are, we have the expertise and capabilities to navigate the complex sterile injectable landscape and help deliver high-quality therapeutics.

We have manufacturing sites specifically designed to help support your complex biologic and small molecule sterile injectable production, including highly potent and cytotoxic compounds for oncology. Our experts can develop, produce and support multiple therapeutic delivery mechanisms.

More from manufacturing

Lyophilization contract manufacturing: Four decades of experience
 

Pfizer CentreOne has the exact SI-ence to manage complex operations, like aseptic lyophilization cycle development and optimization. We’ve been doing it for over 40 years.

There are many complexities facing lyophilized product development and manufacturing, particularly for sensitive complex biologic therapeutics that can destabilize molecules in freeze-dried or frozen formulations. With our extensive experience, we optimize and scale up your lyophilization process to match the needs of your compound.
 

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Our SI Experts

Lisa Ann Thimmesch

Lisa

QA director of documentation and training, McPherson

Lisa Thimmesch has over 20 years of experience supporting Pfizer CentreOne’s customers with regulatory inspection compliance, aseptic and lyophilization manufacturing expertise, quality systems and contract manufacturing quality leadership.

Lisa works directly with more than 50 customers across the development and commercial lifecycle and has extensive experience with quality technical agreements, manufacturing partnerships and issue resolution. Lisa has hosted numerous regulatory agencies from more than 10 different regulatory bodies.
 
Lisa holds a BSc in biology and a Master’s degree in management in leadership. 
 

Kristof Van Praet

Kristof Van Praet

Pfizer CentreOne site lead, Puurs

Kristof has been the Pfizer CentreOne lead at the Puurs site since October 2022 and is the main procurement contact for new product introductions, supporting account management and business development. Kristof’s experience spans 17 years within supply chain and procurement, five of which have been within Pfizer. Kristof has extensive commercial experience focusing on primary components such as vials, syringes, alu caps and needles.


Kristof’s qualifications include two Master’s degrees: maritime sciences at Antwerp university and commercial sciences at Leuven University.
 

David McAllister

David Mcallister

Business development manager and Pfizer CentreOne site lead, Melbourne

David has over 25 years of experience in both the biotech and pharmaceutical industries, spanning the value chain from drug discovery, clinical development through commercial production. David has been at the Pfizer Melbourne site for eight years and in his current role for the past six. This role includes oversight of all co-development and technology transfer activities at Pfizer Melbourne as well as responsibility for Pfizer CentreOne’s commercial and developmental contract manufacturing customer products. The breadth of this role provides David with an opportunity to balance and integrate both the technical and commercial aspects of the business.    
 
David holds a Bachelor’s degree in applied sciences (applied chemistry)) as well as a Ph.D. and MBA from the University of Melbourne.