Manufacturing

SurModics Pharmaceuticals Manufacturing

The Corporate Headquarters and manufacturing facilities of SurModics Pharmaceuticals are located in Birmingham, Alabama.

SurModics Pharmaceuticals specializes in the manufacturing of
long-acting parenteral products including:

• Microparticles
• Injectable solid implants
• Hydrophobic drug salts
• Liposomes

New facility

SurModics Pharmaceuticals has recently announced the purchase of a new facility. This expansion equips the company as a full-service partner in assisting clients in product development and supply at every stage from early feasibility to production of marketed products. The new facility will expand SurModics Pharmaceuticals' capacity for development of customer projects and ability to perform clinical and commercial cGMP manufacturing of drug delivery products for pharmaceutical and biotechnology customers.

SurModics Pharmaceuticals' 300,000+ square feet of facilities include:

• Multiple clean room suites
• Quality Control
• Quality Assurance
• Development laboratories
• Analytical laboratories
• Support services
• Research laboratories
• Expansion areas

Genzyme Pharmaceuticals
Custom Manufacturing Services

Genzyme Pharmaceuticals’ customers benefit not only from our experience in selecting and optimizing synthesis routes for scalable processes at the R&D stage of drug development, but also from efficient transition of their custom projects into cGMP production for the supply of clinical and commercial material. Additionally, stringent corporate quality control systems and extensive regulatory expertise make Genzyme Pharmaceuticals a reliable custom manufacturing partner in supporting drug development projects with tailored CMC and regulatory services.

Genzyme Pharmaceuticals’ core competencies in custom manufacturing include:

Peptide chemistry

• Solid phase and solution phase
• Conjugation with lipids and carbohydrates

Large-scale preparation of non-natural amino acid derivatives and peptide-solubilizing pseudoproline dipeptide building blocks

Multi-kg production of synthetic phospholipids and other lipids such as:

• MPEGylated lipids
• Sphingolipids
• Cationic lipids
• Helper lipids

Polymer production (under GMP conditions)

Carbohydrate chemistry

General organic process chemistry

Liestal Manufacturing Infrastructure

• Solid-Phase peptide synthesis
• General Manufacturing
• Chromatography
• Classified Clean Rooms
• Lyophilization and other drying methods
• HPLC purification (closed handling) in a dedicated room

Typical SurModics Pharmaceuticals' clean room

Genzyme Pharmaceuticals - vessels