Advancing Pharmaceutical Manufacturing
Advanced Training & Advisory in Pharmaceutical Manufacturing Process Development
Independent consulting and advanced training that help biotech, pharma and CDMO teams strengthen process understanding, de-risk industrialization and succeed in scale-up, tech transfer and QbD — grounded in first-principles science.
The Industry Challenges
Most manufacturing issues trace back to process design
Development and manufacturing challenges often stem from insufficient process understanding, weak robustness and limited engineering capability.
The PPI Approach
What makes PPI different
Deep scientific expertise combined with extensive industrial experience — independent, confidential and pedagogy-focused.
PPI Mission
Bridging science and industrial manufacturing
PPI provides science-driven training and advisory support in pharmaceutical process development and manufacturing.
- Strengthen scientific and engineering capabilities
- Reduce development and industrialization risk
- Support successful technology transfer and scale-up
- Build long-term capability through practical, case-based learning
Services
Training, Consulting & Problem Solving
Three pillars to accelerate development, reduce risk and build lasting internal capability.
Advanced Training & Capability Building
- Process engineering training
- Scale-up & scale-down methodologies
- Quality by Design (QbD) implementation
- Process characterization & robustness
Strategic Consulting & Advisory
- CMC & development strategy
- Industrialization strategy advisory
- Risk mitigation & decision support
- CDMO relationship governance
Technical Problem Solving
- Troubleshooting & root-cause analysis
- Critical industrial issue resolution
- Scale-up & industrialization support
- Fill & Finish / parenteral support
Fields of Expertise
From formulation to validation, with a QbD approach
Particle Engineering & solid dosage forms
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Particle Engineering & solid dosage forms
- Mechanical milling, jet milling, nanomilling
- Spray drying, drum drying
- Amorphization
- Powder mixing, fluid-bed drying
- Wet granulation, dry compaction, compression
- Coating, microspheres
Parenteral — Fill & Finish & Lyophilization
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Parenteral — Fill & Finish & Lyophilization
- Formulation, freezing & thawing
- Homogenization, sterile filtration
- Filling of primary containers, stoppering, capping
- Freeze drying (lyophilization)
- Functional analysis for syringes
- Container closure integrity testing (CCIT)
Nanomedicine & Advanced Drug Delivery Systems
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Nanomedicine & Advanced Drug Delivery Systems
- Emulsions, liposomes
- Lipid nanoparticles (LNPs)
- Nanocrystalline suspensions
- Polymeric nanoparticles
- Colloidal science
Technological Project & Technology Engineering
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Technological Project & Technology Engineering
- Needs & objectives definition
- Risk analysis
- User Requirement Specifications (URS)
- Calls for quotation & supplier selection
- Analysis & alignment of quotations
- FAT / SAT follow-up
FOUNDER
Mostafa Nakach, PhD
Founder · Former Sanofi Global Head of Process Engineering
The Founder
Mostafa Nakach, PhD
Pharmaceutical Process Engineering Expert
A pharmaceutical engineer with over 38 years of experience in development and manufacturing across chemical and biotechnological modalities — from early research to commercial manufacturing.
Former Global Head of Process Engineering at Sanofi, acting as the global reference for the development, characterization, robustness and scale-up of commercial manufacturing processes for parenteral drug products.
PhD
University of Toulouse
Sanofi
Global Head, Process Eng.
Visiting Prof.
Author & speaker
Bridging scientific excellence & industrial robustness
Advanced training and advisory that turn process science into dependable, commercial-scale manufacturing.
Let's work together
Let's build robust development together
Discuss your pharmaceutical process development, scale-up or technology transfer challenge. Independent and strictly confidential.