In modern biopharmaceuticals and precision medicine, PEGylation (polyethylene glycol modification) has emerged as a key drug modification technology that enhances the stability, solubility, and pharmacokinetics of active pharmaceutical ingredients (APIs). Leveraging its advanced chemical synthesis platform and GMP manufacturing capabilities, Litchlab provides high-end PEGylated API solutions to help global pharmaceutical companies optimize drug delivery strategies and accelerate the commercialization of innovative therapeutics.
PEGylation: Optimizing Drug Properties for Enhanced Therapeutic Outcomes
PEGylation involves the covalent att achment of polyethylene glycol (PEG) chains to drug molecules or delivery carriers, significantly improving their stability, bioavailability, and reducing immunogenicity and renal clearance. This technology is widely applied in protein therapeutics, oligonucleotides (siRNA/mRNA), antibody-drug conjugates (ADCs), liposomal/nanoparticle drug delivery, and beyond, driving innovation in next-generation drug delivery.
Litchlab’s PEGylated API Expertise
With cutting-edge PEGylation chemistry and stringent quality control, Litchlab offers customized PEGylated API development services, including:
1. High-Performance PEGylated API Synthesis
Monodisperse and polydisperse PEG derivatives: Providing high-purity PEG derivatives of various molecular weights to ensure drug stability and biocompatibility.
Precise PEGylation site control: Optimizing molecular modification strategies to prevent active site masking and maximize therapeutic efficacy.
2. Enhancing Drug Delivery Efficiency Through PEGylation
PEGylated proteins & peptides: Improve solubility, stability, and reduce immunogenicity for enhanced therapeutic efficacy.
PEGylated lipids & nanoparticles: Optimize lipid-based and LNP delivery systems for targeted delivery of mRNA and siRNA therapeutics.
PEGylated ADCs: Enhance solubility and pharmacokinetics of ADCs, improving tumor-targeting efficiency.
PEGylated small molecules: Improve stability in oral and injectable formulations, reducing toxicity and increasing therapeutic windows.
3. GMP Manufacturing & Quality Control
Litchlab adheres to international GMP standards (ICH, FDA, etc.), ensuring consistency and quality in every batch of PEGylated API products:
Advanced purification and characterization techniques: Utilizing HPLC, LC-MS, and NMR to guarantee PEG modification stability and reproducibility.
Optimized process scale-up and industrial manufacturing: AI-driven process optimization for seamless transition from lab-scale to GMP production.
Comprehensive quality assurance system: Ensuring regulatory compliance and product safety with robust cGMP guidelines.
Applications of PEGylated API in Biopharmaceuticals
Application | Advantages of PEGylation | Representative Drugs |
mRNA/siRNA therapeutics | Enhances stability, prevents degradation, improves cellular uptake | mRNA vaccines (e.g., COVID-19 vaccines), siRNA drugs |
Protein/peptide drugs | Extends half-life, reduces immunogenicity, optimizes PK profile | Pegfilgrastim (long-acting G-CSF), PEG-IFNα (long-acting interferon) |
Antibody-drug conjugates (ADCs) | Improves ADC solubility, enhances biodistribution, boosts anti-cancer efficacy | Trastuzumab-DM1 (T-DM1), Enfortumab vedotin |
Trastuzumab-DM1 (T-DM1), Enfortumab vedotin | Enhances targeted delivery, increases circulation half-life | Doxil (PEGylated liposomal doxorubicin) |
Litchlab: Partnering with Global Pharma to Accelerate Drug Innovation
As a leader in PEGylated API technology, Litchlab continues to push the boundaries of precision drug delivery by enhancing the efficiency and safety of novel therapeutics. With state-of-the-art chemical modification capabilities, customized development strategies, and GMP-certified manufacturing, Litchlab empowers pharmaceutical companies to develop scalable, high-performance PEGylated drugs that advance clinical progress and revolutionize patient care.
For more information, please feel free to contact us at:
E-Mail:RD2@Litchlab.com
