Sterile-Asymchem Labs.

Sterile Preparations

We have comprehensive sterile formulation development and manufacturing capabilities, with rich experience in the research and filing of innovative drugs and generic drugs, and can provide flexible and comprehensive solutions from preformulation to commercial production based on client needs. We can meet the requirements of various packaging formats such as vials, prefilled syringes, cartridges, low density polyethylene bottles and more, and have successfully delivered over 200 injection projects and over 70 sterile formulation projects with new molecule types.

Supported Dosage Forms

Inhaled Liquid Preparations, Nasal Sprays

Single dose / multi dose eye drops

Liposomes, micelles, LNP, in situ gels and other complex formulations

Service Capabilities

Formulation R&D

A professional, efficient and stable project team with rich project experience, a sound quality management system and advanced R&D laboratory equipment.

Covers full set of operations including weighing, solution preparation, filtration, filling, ampoule hydrogen oxygen flame sealing, autoclaving, freeze drying and capping, capable of fully simulating the entire GMP production process to ensure seamless connection between R&D and manufacturing.

Formulation Manufacturing

We have 5 sterile formulation manufacturing workshops complying with cGMP standards.

Equipped with internationally advanced equipment, covering multiple production lines including terminal sterilization (ampoules), aseptic processing (vials), blow fill seal (BFS), prefilled syringes (PFS) and cartridges.

Sound quality management system, strict sterility assurance system and experienced manufacturing and technology transfer team ensure smooth project transfer and scale up manufacturing.

Can efficiently complete full process services from preclinical research to commercial manufacturing.

Oligonucleotide and Peptide Formulations

Newly built 6,000m² workshop for prefilled syringes and cartridges

Prefilled syringe formulation production line

Prefilled syringe filling line

Automatic Denesting

Prefilled syringe packaging line

Cartridges

Prefilled syringe

Injector Pens

Autoinjector

Safety Protection Devices

Injection Assist Devices

The core equipment in the prefilled syringe and cartridge workshop are from world's leading brands, all equipped with electronic batch records to meet regulatory audit trail requirements.

Technology Platforms

Sterile Formulation Solubilization Technology

Oligonucleotide Technology

RDC non radioactive prodrug formulation technology

Ophthalmic Formulation Technology

Complex Formulation Technology

Filter

Freeze dryer

Tangential Flow Filtration (TFF) System

Microfluidic System

Microfluidizer high pressure homogenizer

Filling and Stoppering Machine

Blow fill seal machine

Solution Preparation Room

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