PROMISE
by Skyepharma
All-in-one CDMO offering for
Products for Rare diseases,
Oncology, Immunomodulation,
in a Safe Environment
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For rare disease and specialty pharma companies, every asset is mission-critical.
The PROMISE of our CDMO Skyepharma is to secure the path to commercialization of your HPAPI rare drug project.
Skyepharma is a French independent and fully integrated CDMO specializing in complex oral solid dosage forms.
With over 25 years of expertise and the team of more than 200 experts, we offer development, manufacturing and packaging services to pharmaceutical companies all over the world.
Our Integrated Offer for Rare Disease Medicines
Accelerate patient access to high-value therapies
Accelerated Go-To-Market Model
We DIAGNOSE your asset complexity and CMC risks
We DESIGN intelligent CMC strategies to accelerate patient access
We DELIVER via a fast and efficient roadmap to market
Ready-To-Operate Plateform
Purpose Built Facility
Dedicated facility for complex API
(HPAPI, and ATC – L, G, H)
Flexipack for small & niche populations
Purpose Built Facility
Dedicated facility for complex API (HPAPI, and ATC – L, G, H) Flexipack for small & niche populationsA team fully integrated with yours
End-to-end CMC & regulatory expertise
From early development to lifecycle management
A team fully integrated with yours
End-to-end CMC & regulatory expertise From early development to lifecycle managementWhy PROMISE Is Made For Your Drug Product
SAFETY
Dedicated containment areas (up to OEB5+)
Enhanced operator protection
Robust cross-contamination control
Your molecule is safe with us !
SPEED
Fast tech transfer
Robust scale-up
Seamless clinical-to-commercial transition
We de-risk the path to market !
FLEXIBILITY
Small batch sizes and multi-strength manufacturing
Smart validation bracketing strategies
Flexible packaging and global supply (160+ countries)
We enable flexible supply for small populations !
EXPERTISE
Responsive regulatory support
CMC technical support & development studies
Workflows tailored to your needs
We act as an extension of your CMC team !
From Clinical Assets to Commercial Supply : We Deliver Every Step
STEP 1 Development
We do formulation and prototyping of your rare drug product for you
STEP 2 Pilot scale Up
We do apply Quality by Design Process (QbD)
STEP 3 Clinical Trial
Your clinical trial material is prepared by our team
STEP 4 Commercial Manufacturing & supply
We do process validation and market launch of your rare drug product
Lab & Pilot Area
Development batches :
R&D prototypes, clinical material
Commercial production :
small/mid-size commercial production
Suite for non-GMP and GMP:
450m² segregated area
and contained equipment suite
Equipments for granulation / milling / tabletting / coating /capsule filling / packaging
Lab & Pilot Area
Batch size : 0.5 – 70 kg
Development batches :
R&D prototypes, clinical material
Commercial production :
small/mid-size commercial production
Suite for non-GMP and GMP:
450m² segregated area
and contained equipment suite
Equipments for granulation / milling / tabletting / coating /capsule filling / packaging
Secondary Packaging
Batch size : Staring from one shipper case
Target Therapeutic Areas Where PROMISE Delivers the Most Value
Customer Case
Flexible manufacturing and packaging strategy for a rare disease immunomodulatory therapyCustomer Case
Flexible manufacturing and packaging strategy for a
rare disease immunomodulatory
therapy
Client’s Profile
Rare disease biotech with limited pipelineProject Request
CDMO services to rapidly bring alate clinical stage immunomodulatory asset
from development to patient accessClient’s Profile
Rare disease biotech with limited pipelineProject Request
CDMO services to rapidly bring a late clinical stage immunomodulatory asset from development to patient accessCustomer Challenges
Small, Dispersed Patient Population
<5,000 patients globally with high geographic scatter
Opt for Flexible Packaging
Bright stock model
(safe long-term storage in HDPE bottle or blister)
+
On demand allocation for commercial packaging
(from 10 to 2 500 units)
Complex Dosage Requirements
5 distinct strengths
(10 mg to 60 mg)
pediatric & adults
Benefit from Multi-Strength from Single Blend
We do compression-based differentiation to streamline production
Life-Treatening Condition
Urgent need for rapid patient access to treatment
Choose time-to market
We value enhanced time-to-market approach thanks to robust process by applying "Quality by Design" methods
High Regulatory Pressure
Orphan drug designation & conditional approval pathways
Trust our regulatory expertise
Dedicated CMC and regulatory teams to ensure support to rush questions from agencies
Impact Analysis
From Development to Patients in Record Time
Faster Patient Access
3-Year Timeline
Tech transfer ➔ Pivotal BE ➔ Launch
Accelerated pathway achieved vs industry average of 4-5 years for rare disease New Chemical Entity
15–45 Days
Access Post-Approval
First patients treated immediately
5 Dosages
Validation Efficiency
10mg to 60mg validated with only 5 batches (vs typical 15+), saving 6 months in project.
Global Scale
Flexible Supply
Supply secured across 12 countries with batch sizes adapted to local needs.
Fully Integrated, cGMP Industrial Facility
We have a very strong regulatory track record with cGMP, FDA, ANSM and ANVISA approval enabling Skyepharma to deliver in more than 160 countries.
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Our Client Testimonials
