TTY has scientific expertise in developing PLA (Poly lactic acid) /PLGA (Poly lactic-co-glycolic acid) (FDA-approved biodegradable polymers) microsphere formulation to control drug release throughout different technologies, including single and multiple emulsion, phase separation, and particle collection. We are capable of providing professional GMP production for small molecule and peptide microspheres.
Development Capabilities for Microspheres
Our pharmaceutical development team is able to provide one-stop-shopping for microsphere development including
- PLA/PLGA design and GMP production
- Formulation and process development (including impurity identification)
- Animal PK studies
- GMP Production and packaging
GMP-grade functional excipient factory & excellent customization capabilities
To control the release profile of injectable microsphere products, TTY's functional excipient factory strongly supplies a variety of customized PLA and PLGA polymers.
- Specific ratio of LA/GA
- Molecular weight from 5,000 to 300,000 Daltons
- End group modification
- Customized polymer conformation, such as linear and star polymers
- Batch size from gram to kilogram scale
- GMP-grade PLGA /PLA production
Outstanding Formulation Design Competence
Based on the product properties, TTY is able to develop different types of GMP-grade injectable microspheres for clinical trials batch or commercial scale for NDA or ANDA products.
Our capacities include:
- Release control from a week up to 6 months
- Encapsulation of small molecules and peptides
- Sufficient experience in handling and manufacturing microsphere hydrophilic and hydrophobic products
- Batch size from lab scale to hundreds of thousands of vials
For microsphere manufacturing, TTY has two GMP factories.
Efficient Animal PK Analysis
- TTY's PK laboratory supports quick in-house formulation screening in vivo to save time and makes formulation development more efficient.
- Clinical PK study samples can be detected by LC/MS/MS.
Brilliant Synthesis Ability
Our synthesis laboratories are capable of providing several supportive solutions during formulation development.
- Synthesis and development of GMP pharmaceutical grade of functional excipient
- Synthesis of impurity standards
- Identification of impurity, and preparation of raw materials, intermediates, and finished products