Demo facility

Demo facility

Demo facility

About the plant

Demo facility

---

Compliance

• ICH
• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• ANMAT (Argentina nueva GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• ISP (Chile BPM)
• INVIMA
• MSPAS
• COFEPRIS
• DIGEMID
• MHRA (UK GMP)
• SQF (Safe Quality Food)
• IFS
• BRCGS
• Halal Research Council
• UAE Ministry of Health & Prevention
• SFDA (Saudi Food & Drug Authority)
• NSF
• TITCK (Turkish Health Authorities)
• 9001
• 13485 (Medical devices)
• 14001
• 45001
• 22000 (Food)
• 22716 (Cosmetics)
• IFS Food
• IFS HPC
• ICHQ3A
• ICHQ3B
• ICHQ3D
• ICHQ1A
• ICHM7

---

Activity

• Blood products / PDMPs, Cell therapy derivatives / Secretomes, Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, Human / animal extracted products, LBP (Live Biotherapeutic Products), ATMP (Advanced Therapies), pDNA, gRNA, Minicircle DNA, mRNA, Implants, Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Aerosol, Powder, Nebulization, Bottles, Tubes, Sprays, Bulk, Sachets, Stick packs, Ampoules, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Oral foams, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Lyophilizates, Lozenges, Gummies, Orodispersible / Sublingual films, Buccal (muco)adhesive films, ODS / Oral strips, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Dropper bottles, Ophtalmic dispensers, Semisolid forms, Liquid forms, Patches, Rectal and vaginal dosage forms, BFS (Blow Fill Seal) ampolues, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, COSMETICS, NUTRACEUTICALS, SERVICES, PARTICLE ENGINEERING, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals, Building Blocks, Skin products, Hair and scalp care products, Products for nails and cuticles, Oral hygiene products, Skin care, Skin cleansing, Hair removal, Hair bleaching, Correction of body odor or perspiration, Shaving, pre-shave and after-shave, Make-up, Perfumes, Sun protection and self-tanning, Other skin care products, Hair and scalp care and cleansing, Hair coloring, Hair styling, Other hair and scalp care products, Nail polish and nail polish remover, Nail care and hardening, Nail glue remover, Other nail and cuticle products, Hygiene , Mouthwashes or mouth sprays, Teeth whitener, Other oral hygiene products, Solid or compact powder, Loose powder, Cream / paste, Liquid, Spray, Others, Foam, Solutions, Suspensions, Emulsions, Gels, Oils, Blister packs, Bottles: Plastic, Bottles: Glass, Ampoules: Glass, Ampoules: Plastic, Vials, Doypacks / Pouches, Strip packs, Spray blottles, Syringes, Cans / Tins, ASOs (Antisense oligonucleotides), siRNA, miRNA, Aptamers, PMOs, CpG ODNs manufacturing

---

Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• Controlled substance: High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
• BSL: 1, 2, 3, 4
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

---

Batch Size / Reactor

• Small, Medium, Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L, > 5000 L, 1 - 10 sqm, 10 - 50 sqm, 50 - 100 sqm, 100 - 200 sqm, > 200 sqm, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L

---

Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, 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, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, 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, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Fill and finish, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis, Efficacy studies, Samples manufacturing, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Medical Cannabis, Oligonucleotides & Nucleic acids, Proteomics, Metabolomics, Drug Product – Liquid, Drug Product – Solid, API / Excipient – Liquid, API / Excipient – Solid

---