FDF / DRUG PRODUCTS SERVICES in MENAT
Nextage Therapeutics is a premier Israeli CDMO with over 20 years of expertise in delivering end-to-end pharmaceutical solutions. We specialize in the development and GMP manufacturing of complex...
About the plant
Nextage Therapeutics Ltd. is Israel´s leading CDMO with 20 years of exceptional track record,
15,000sqf cGMP and ISO-13485 compliant manufacturing facilities, trusted by more than 400
customers and having extensive experience in more than 3000 projects, including 200 innovative
drug products and medical devices. The company provides development and commercial
manufacturing services for pharmaceuticals and medical devices across a broad range of
technologies and dosage forms, including small molecules drug substance synthesis, formulation
development, scale up and sterile manufacturing, from preclinical development through clinical
trials and commercial supply.
A wide range of services:
• Chemistry - Expertise in custom synthesis, process development and optimization for new
drug candidates, functional excipients and lead compounds to meet your project
requirements.
• Preparative Separation & Purification - Available for synthesized molecules and related
substances.
• Pre-formulation and Formulation – profound experience in developing custom
formultions that deliver the right therapeutic performance, are stable, scalable and can
be consistently manufactured, meeting all regulatory and quality requirements. In
addition, Nextage has profound experience in nano-liposomes based delivery systems and
specific expertise in targeted drug delivery across the blood-brain-barrier.
• Manufacturing - cGMP/ISO13485 complaint, flexible and reliable custom manufacturing
services in liquid, semi-solid, or lyophilized formulations for sterile and non-sterile
products.
• Analytical and Bioanalytical services – Development and validation of analytical
(chemical and bio-analytical) testing methods to support all your analytical requirements.
Full cGMP compliant analytical support including quality control for raw materials, in
process intermediates and finished product release, forced degradation, cleaning
validation and long term stability studies, from product development phases to
commercial supply.
Compliance
- ICH
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- 13485 (Medical devices)
Activity
- Implants, Oral liquids and semisolids, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Bottles, Tubes, Sprays, Bulk, Sachets, Stick packs, Ampoules, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Oral foams, Terminal sterilization, Fill&Finish, Dropper bottles, Ophtalmic dispensers, Semisolid forms, Liquid forms, Patches, Rectal and vaginal dosage forms, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): N/A
- Controlled substance: Low potential for abuse
- BSL: N/A
- Therapeutic areas: N/A
- Markets: N/A
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Primary packaging, Secondary packaging, Labeling, Serialization, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Residual solvents (GC-MS), Medical Cannabis, Oligonucleotides & Nucleic acids, Drug Product – Liquid, API / Excipient – Liquid, API / Excipient – Solid
