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We continuously look for opportunities to drive process improvements.

For one project, our scientists reduced reaction time by ~ 30% using a range of PAT technologies to track processes to minimize impurity formation while maximizing batch yield.

Development & Tech Transfer

We make sure your compound's journey is as smooth as possible.

With Pfizer CentreOne, your molecule is in good hands. Our custom API sites have executed hundreds of complex technology transfers from Pfizer R&D sites around the globe.

Mastery in tech transfer, process optimization and scale-up

When you entrust your API with us, you get continuous support from your dedicated analytical, engineering, chemistry and microbiological team. Experts in their fields, they can help you solve the complex technical challenges involved with small-molecule API synthesis, such as:

  • Increasing process robustness
  • Identifying and reducing impurities
  • Scaling up fermentation
  • Improving fermentation titer
  • Resolving crystallization issues

From the moment we start working with you, we look for ways to improve your compound's manufacturing process. Your dedicated team of experts will aggressively pursue how to manufacture your API using the most efficient process possible, providing you magnified savings at commercial production. For example:

  • Reducing process time. The longer your process takes, the more it costs. We use sophisticated techniques such as telescoping and PAT to shrink process time where possible.

  • Improving yield. Since poor yield leaves money on the table, we may, for instance, fine-tune your crystallization conditions to reduce API losses or use analytical process monitoring to achieve your ideal reaction endpoint.

Optimization of your process continues throughout our partnership:

  • Lab- and pilot-scale process optimization
  • Continuous process improvement at scale

Analytical development

You benefit from the breadth of Pfizer’s analytical development capabilities. Our scientists have almost every analytical tool available in-house, such as a full suite of chromatography equipment, including UHPLC; elemental analysis equipment, including ICP-MS; and microbial testing instrumentation. See our full list.

Most of our colleagues have more than 15 years of experience across a wide range of complex small molecules. Our dedicated method transfer team, who deeply understand FDA and ICH validation guidelines, orchestrate a smooth, compliant transfer of your method into our site. Our analytical chemists develop and trouble-shoot your method; they’re experts at isolating and identifying impurities through our onsite structural elucidation technologies. And our quality team, who perform in-process testing and/or release, focus on efficiency: getting it right the first time so that you don’t run into issues that could trigger investigations, delays or batch failures.

Pilot plants

When time for scale-up, our experts understand what it takes to make a process commercially viable, skirting yield, impurity and reaction-time issues as they take your molecule from flask to commercial scale.

One the most powerful tools for scale-up is the pilot plant. Taking intermediate jumps in scale not only mitigates your technical risk but also saves you raw material, which saves you money.

We have pilot plants for both chemistry- and fermentation-based APIs. In addition to scale-up, our chemistry pilot plants also provide cGMP manufacturing for both clinical and small-scale commercial production.

Service overview

Our collaboration with you begins as early as Phase II and includes:

Analytical development activities

  • Impurities and degradation identification
  • Compendial method verification
  • Method development
  • Fate and purge studies

Process development

  • Route selection
  • Process optimization, including
    • Telescoping
    • PAT
    • Process throughput
  • Cleaning method development, validation and recovery studies
  • Pilot/scale-up

Technical and regulatory affairs support

  • Regulatory agency inquiries and inspections
  • CMC submission support