Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Cell Therapy company with excess Cleanroom capacity

About the plant

Green Phoenix Labs GmbH is a biopharmaceutical company specializing in Cell Therapies (Advanced Therapy Medicinal Products, ATMPs). As a Contract Development and Manufacturing Organization (CDMO), we offer comprehensive services for the development and manufacturing of these modern therapeutic products.

Our activities are conducted at our state-of-the-art facility in Bochum, Germany. The site is ideally situated within a Biomedical Research Center and in close proximity to the University´s technology campus. The facility features GMP-compliant Class A/B cleanroom areas and is designed to support all phases of development as well as pilot and initial commercial-scale manufacturing.

Green Phoenix Labs possesses specific expertise in GMP-compliant drug development of cell therapeutics derived from autologous and allogeneic epithelial cells.

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Certifications

• EMA (EU GMP)

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Activity

• Cell therapy derivatives / Secretomes, ATMP (Advanced Therapies), Implants, Injectables, FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• 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)
• DEA: Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1
• 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, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system
• Markets: EMA (EU)

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Batch Size / Reactor

• Small, Medium, Batch

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Services

• Regulatory services, Development services, Manufacturing services, Quality Assurance services, Packaging, Logistics, Clean room rental, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Sterile product manufacturing, Non sterile product manufacturing, Tech transfer, Pilot plant, Research batches, Engineering batches, Pilot batches, Registration batches, Batch records, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling

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