Actylis Eugene

Actylis Eugene

Chemical Process Discovery, Development, cGMP, and Commerical Manufacturing Services.

About the plant

Providing R&D and Manufacturing Services to All Industries Since 1980

• Purpose-built GMP facility
• Dedicated R&D facility
• 60+ employees, over 50% scientific staff
• Synthetic and Analytical Development Teams (over 75% PhD)
• Project Management Team
• Proven track record of solving complex chemical and analytical problems
• Experienced, fast, and flexible team; clients appreciate our collaborative approach and access to our scientists and management

Actylis Eugene Facilities:

• R&D Facility: 15,000 sqft with 26 fume hoods and four configurable manufacturing suites (up to 100 L capacity). Dedicated to non-GMP work.
• GMP Manufacturing Space: 30,000 sqft with seven configurable manufacturing suites (up to 2 x 100 gallon capacity). Suitable for API Phase I-III and commercial manufacturing.

Focus Areas:

• FDA-compliant GMP manufacturing of Drug Substance for Phase I clinical trials
• Manufacturing route discovery and process development for all industries
• Expertise in preclinical and clinical API manufacturing
• Analytical development, validation services, and specifications development

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Certifications

• ISO
• FDA (cGMP)

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Building Blocks manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III
• 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 III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs
• Markets: FDA (USA), EMA (EU), Health Canada (Canada), MHRA (UK), TGA (Australia)

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Batch Size / Reactor

• Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, 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, Batch certification / release, GMP documentation, CMC regulatory support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Solid form selection, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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