Global CDMO for sterile and non-sterile pharmaceuticals: development, fill-finish, clinical supply and packaging.
PCI Pharma Services
Philadelphia (Headquarters) · Bedford, NH · Bridgewater/Boston · Madison, WI · Rockford, IL · San Diego, CA · Burlington, ON · Mississauga, ON · Berlin (Großbeeren) · Bridgend · Hay-On-Wye ·New on Amplifa
Global CDMO across the entire product life cycle
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) headquartered in Philadelphia, founded in 1971. The company supports pharmaceutical and biopharmaceutical customers across the entire product life cycle – from drug development and analytics through sterile manufacturing (fill-finish) including lyophilization to commercial packaging. In the sterile area, vials, cartridges and prefilled syringes are aseptically filled, among others on the OPTIMA H3-10 line in León with isolator technology and up to 12,000 units per hour. Further service areas include Advanced Drug Delivery and drug-device combination products (autoinjectors, pens, needle safety devices, on-body devices), Clinical Trial Services with packaging, labeling, storage and distribution to over 100 countries as well as cold chain down to -196 °C. Non-sterile manufacturing covers oral dosage forms including highly potent active ingredients. With more than 8,000 employees at 38 GMP sites in North America, Europe and Asia-Pacific, PCI serves industries such as Pharma, Biopharma, Biotech and Medical Devices.
- Site
- Philadelphia, PA
- Processes
- Sterile Drug Development & Manufacturing (Sterile Fill-Finish), Lyophilization (Freeze-Drying), Prefilled Syringe Filling (Aseptic Filling of Syringes, Cartridges, Vials), Drug-Device Combination Product Assembly (Autoinjectors, Pens, Needle Safety Devices, On-body, Non-Sterile Drug Development & Manufacturing (oral dosage forms, High Potency), Primary Packaging (Blisters PVC/PVDC/Aclar/cold form foil, Bottles & Desiccant, Pouches, Sachets,, Secondary Packaging (Cartoning, Kitting, Overwrapping, Pouching, Walleting, Child-resistant,, Tyvek Blistering
- Materials
- mRNA, Monoclonal Antibodies (mAbs), Proteins, Oligonucleotides, Nanoparticle-based drugs, Monoclonal Antibodies, Highly Potent Active Ingredients, Blister materials (PVC/PVDC/Aclar/Cold form foil)
- Certificates
- GMP (FDA/EMA), Annex 1 (sterile facilities)
- Founded
- 1971
- Employees
- >8000
- Industries
- Pharma, Biopharma, Biotech, Medical Devices, Specialty Generics
- 01
Pharmaceutical development, formulation and analytics
- 02
Sterile or non-sterile drug manufacturing (fill-finish)
- 03
Drug-device combination assembly (autoinjectors, pens, on-body devices)
- 04
Primary and secondary packaging, labeling, serialization
- 05
Clinical Trial Services: storage, cold chain and worldwide distribution
- 06
QP certification, release and Quality & Regulatory Services
Product groups and processes
mRNA
Sterile fill-finish capacities for mRNA-based drugs and biologics.
Monoclonal Antibodies
Development, filling and packaging of biological products such as monoclonal antibodies.
Proteins
Handling of complex sterile protein-based formulations.
Oligonucleotides
Sterile manufacturing and packaging of oligonucleotide drugs.
Nanoparticle-based drugs
Specialized process capability for nanoparticle-based formulations in fill-finish.
Highly Potent Active Ingredients
Non-sterile manufacturing of oral dosage forms with highly potent and non-highly potent molecules.
Blister materials (PVC/PVDC/Aclar/Cold form foil)
Primary blister packaging for moisture-, light- and oxygen-sensitive products.
Lyophilization (Freeze-Drying)
Process for stabilizing complex sterile formulations and biologics.
Services and dosage forms
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Sterile Drug Development & Manufacturing (Sterile Fill-Finish)Joining | – | – | – | – | Nanoparticles, mRNA, Monoclonal Antibodies (mAbs), Proteins, Oligonucleotides, other biologics |
| Lyophilization (Freeze-Drying)Engineering | – | – | – | – | Biologics, Complex sterile formulations |
| Prefilled Syringe Filling (Aseptic Filling of Syringes, Cartridges, Vials)Joining | – | – | – | 12000 units/hour | Biologics, sterile injectable drugs |
| Drug-Device Combination Product Assembly (Autoinjectors, Pens, Needle Safety Devices, On-bodyAssembly | – | – | – | 3 units per minute – 300 units per minute | Vials, Prefilled Syringes, Cartridges |
| Non-Sterile Drug Development & Manufacturing (oral dosage forms, High Potency)Joining | – | – | – | – | highly potent and non-highly potent molecules, oral dosage forms |
| Primary Packaging (Blisters PVC/PVDC/Aclar/cold form foil, Bottles & Desiccant, Pouches, Sachets,Assembly | – | – | – | – | PVC, PVDC, Aclar®, Cold form foil |
| Secondary Packaging (Cartoning, Kitting, Overwrapping, Pouching, Walleting, Child-resistant,Assembly | – | – | – | – | – |
| Tyvek BlisteringAssembly | – | – | – | – | – |
| Labeling (Parenterals, Injectables, Just-in-Time Labelling, Over-labelling, Serialization &Assembly | – | – | – | – | – |
| Cold Chain & Ultra-Cold Chain Storage and Distribution (CRT 15°C–25°C, 2°C–8°C, down to -196°C)Testing | – | – | – | – | – |
| Analytical Development & Testing ServicesTesting | – | – | – | – | – |
| QP Certification & Release / Quality & Regulatory Services (QRS)Testing | – | – | – | – | – |
| Clinical Trial Packaging, Storage & Distribution (200+ protocols/year, >100 countries)Assembly | – | – | – | – | – |
| Comparator Sourcing, Distribution & LogisticsEngineering | – | – | – | – | – |
| Temperature Controlled Packaging Design & DevelopmentEngineering | – | – | – | – | – |
| PCIFastTrack™ & IRT Integration (Suvoda)Engineering | – | – | – | – | – |
| Pharmaceutical Development (Formulation, Process Development, Validation, Tech Transfer)Engineering | – | – | – | – | – |
| Device Assembly & Testing (52 million FDA-approved Devices, Human Factors Engineering, FunctionalTesting | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Aseptic Filling Line (Vials, Cartridges, Prefilled Syringes) with isolator technology | OPTIMA H3-10 | 1 | – | – | León, Spain |
| Sterile Filling Lines (FDA-approved) | – | 9 | – | – | global (US & Europe) |
Additional services
Quality and regulation
PCI operates 38 global GMP sites to FDA and EMA standards, including Annex 1-compliant sterile facilities. 66 successful regulatory inspections have been completed, including the first successfully completed ICMRA inspection of a CDMO.
| Evidence | Philadelphia | Berlin (Großbeeren) | León |
|---|---|---|---|
| GMP (FDA/EMA) | |||
| Annex 1 (sterile facilities) |
History
- 1971
Founded in Philadelphia.
Over 100,000 clinical shipments worldwide; over 60 commercial product approvals; over 52 million FDA-approved devices assembled; over 90 product launches per year.
First CDMO with a successfully completed ICMRA inspection; 66 successful regulatory inspections.