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Oral Solid Dose Development

Pfizer CentreOne excels in the development and manufacture of oral solid dosage forms, including highly potent products.

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Can Pfizer help me develop and manufacture my oral solid dose product for both clinical and commercial needs?

Yes, we sure can. Collaborate with Pfizer CentreOne, and we’ll help guide your development project.

Deirdre Whelan, Contract Manufacturing Operations, Ireland

Pfizer CentreOne Manufacturing Site in Freiburg, Germany

Intelligent collaboration with Pfizer CentreOne

Our experts collaborate with you to optimize your formulation and processes, working to reduce downstream risk wherever possible.

We have used our development expertise to overcome many technical challenges for our customers over the years, including:

Content uniformity for low-dose products
Solving coating challenges
Resolution of process issues (e.g. tablet sticking or cracking)
Hard-to-procure commodities that could threaten launch timelines
Unexpected or unidentified impurities in the API
APIs that require complex processes

Range of Services: Clinical Phases to Lifecycle Management

Clinical Phases

Development & manufacturing
Technical transfer
Formulation optimization
Scale-up/validation

Submission

CMC preparation
Final package
Pre-approval inspection

Launch

Drug to market
Production efficiency studies

Lifecycle Management

Cold-chain management
Supply/distribution
Drug delivery expansion

Capabilities at a glance

Oral Solids

Early stage formulation development
Process validation and optimization
Full development of analytical methods
Scale-up from lab to pilot to commercial
Specification development

Regulatory support - pre and post-launch
Clinical manufacturing Ph I - III
Full range of OEB 1-5
Tablets, Capsules, Granules
Controlled substances (III - IV)