Ascendia Pharmaceutical Solutions

Ascendia Pharmaceutical Solutions

Your trusted GMP CDMO for advanced aseptic and non-aseptic pharmaceutical drug product manufacturing, formulation development, and analytical testing.

About the plant

Ascendia Pharmaceutical Solutions´ expansive 60,000 square-foot state-of-the-art facility in North Brunswick, New Jersey, has aseptic and non-aseptic cGMP manufacturing capabilities for small molecule and biologic drug products (DP). Manufacturing is housed in the same location as our formulation development, analytical testing, and other services, creating a convenient "one-stop shop" for numerous benefits for clients.

Visit our website: Ascendia Pharmaceutical Solutions

---

Certifications

---

Activity

• Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Bottles, Bulk, Oral solutions, Oral suspensions, Oral emulsions, Tablets, Hard capsules, Powders, Lyophilizates, Buccal (muco)adhesive films, Fill&Finish, Dropper bottles, Ophtalmic dispensers, Liquid forms, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, COSMETICS, NUTRACEUTICALS, SERVICES, OLIGONUCLEOTIDES, PARTICLE ENGINEERING 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)
• Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
• BSL: N/A
• 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, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens
• Markets: FDA (USA), EMA (EU), Health Canada (Canada)

---

Batch Size / Reactor

• Small, Medium

---

Services

• Development services, Manufacturing services, Analytical / QC services, 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, 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

---