Oral Solid Dose Manufacturing, OSD Manufacturing Process

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Oral Solid Dose Manufacturing

Making the complex, simple:
A roadmap for your OSD journey

Uncover unique insights from global Pfizer OSD scientists and manufacturing experts on the challenges facing your journey to market.

Discover how to navigate these complexities with confidence to bring your product to patients on time, without delay.

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Support your oral solid dose manufacturing, every step of the way

As a part of Pfizer and backed by industry-leading resources, we’re your dedicated and dependable oral solid dose manufacturer that is the right fit in all senses - from manufacturing scale to mindset. We get you.

Our oral solid dose manufacturing network includes sites in:

Germany (Freiburg)
Ireland (Newbridge)
Italy (Ascoli)
Japan (Nagoya)

Let's collaborate

Made by an altogether different kind of CDMO

At Pfizer CentreOne, our open and collaborative approach combined with years of experience helps us support you in taking your compound from scale-up to commercial OSD manufacturing. We have integrated cGMP pilot facilities dedicated to process optimization, clinical drug manufacturing, and scale-up technology transfers that help us on our mission to deliver on what we promise.

Our goal is to always remain transparent, working with you to redesign and optimize your manufacturing processes wherever possible.

Whether you require clinical or commercial manufacturing; we’re dedicated to your product’s long-term success and work closely with you to help produce your products reliably and efficiently.

We deliver multi-product and high containment solutions and manufacturing technologies including:

OEL 1-5 engineering controls from 10,000 to 0.01 μg/m3 manufacturing with fully segregated suites for non-potent and highly potent (HPOSD) compounds
Specialized solid dose delivery technologies (e.g. active coating, laser drilling)
Complex processes (e.g. controlled drugs, multi-particulates low dose/high dose compounds)
Primary and secondary packaging, pouching, serialization, and aggregation
Advanced process capabilities (e.g. real time release testing)

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

Drug Substance

Compound classifications

Highly active compounds
Immunosuppressants
Sensitizers
Hormones
Controlled drugs
Cytostatics/Cytotoxics

Manufacturing capabilities

Dry granulation
Roller compaction
Wet granulation
Fluid bed granulation
High shear granulation
Wet & dry milling
Extrusion/Spheronization
Hot melt extrusion
Compression
Encapsulation
Film coating
Sugar coating
Active coating
Solvent coating
Fluid bed coating
Branding/Printing
Automated inspection
Serialization

Delivery technologies

Capsules
- Immediate-release
- Modified-release
- Powder-filled
- Pellet-filled
Pellets
- Immediate-release
- Modified-release
- Enteric-coated
Tablets
- Immediate-release
- Modified-release
- Fast-dissolve
- Bi-layer
- Active-coated
- Sugar-coated
- Dual-active overcoat
- Laser tablet drilling

Global supply chain services

Serialization/track-and-trace programs
Primary and secondary packaging development
On-site regulatory experts
Gateway services for EU and Japanese markets, including quality release support and multi-lingual secondary packaging, labelling and package inserts

Primary and secondary packaging

Packaging Centers of Excellence for bottle, blister and pouching
Automated lines
High-volume and flexible-run packaging
OEB 1-5 (OEL 10,000-0.01 μg/m3)
Cold-forming and thermoforming capability
Containment control (i.e. packaging of hormone and highly potent products)
Packaging on demand
Humidity control
State-of-the-art inspection technologies

Let’s collaborate

Oral Solid Dose Manufacturing powered by Pfizer

Making the complex, simple: A roadmap for your OSD journey