The 5th Polypeptide Industry Innovation and Development Forum (Suzhou) ended successfully. Shanghai Hanyao booth received real questions from the industry around the whole process of polypeptide research and development, synthesis, purification, post-processing, production and quality control. We will organize the high-frequency core questions into a text, in the form of a question and answer, with multi-product collaboration full chain coverage ideas, give a landing industrialization solution.
Ask
how to quickly and stably synthesize long-chain polypeptides and successfully realize process amplification?
When synthesizing long-chain polypeptides (e. g. GLP1 analogs, complex cyclic peptides, PDC), the industry generally faces pain points such as low coupling efficiency, many missing sequences, unsatisfactory crude purity, declining yield after amplification, poor inter-batch consistency, and incomplete compliance data.
We adopt full series of compliance control platform for polypeptide synthesizer collaborative Resolution:
- peptide Synthesizer Full Series (PurePep®Chorus, Symphony®X. PurePep®Sonata®) Covering the full scale of research and development small-scale test-process optimization-pilot production, using high-precision fluid control, optimized mixing and mass transfer mode, greatly improving the synthesis stability and one-time success rate of long-chain, difficult-to-ring, multi-modified polypeptides.
- The key process parameters can be accurately transmitted and amplified 1:1, avoiding the common problems of purity diving and yield decline from laboratory to pilot test.
- The whole department supports 21 CFR Part 11 compliance requirements, with built-in electronic records, audit tracking, rights management, complete and traceable data, and directly meets CMC declaration and GMP on-site verification.
- Materials can be transferred before and after synthesis and between processes through ABC Transfer.®Ultra-clean aseptic transfer solution closed transport, no exposure, no cross-contamination, to ensure the safety of the whole process of high activity polypeptide.
Ask
how to reduce solvent consumption and improve system stability in large-scale purification?
The large-scale purification of polypeptides generally has pain points such as large amount of organic solvent, high operating cost, high environmental pressure, easy leakage and blockage of the system, frequent downtime of high-salt buffer conditions, etc., which directly affect continuous production and cost control.
We take SFC Supercritical Fluid Chromatography System Liquid Chromatography Accessories and Consumables combination scheme, to achieve green and efficient and stable operation of the double promotion:
- the Sepiatec SFC system uses CO₂ as the main mobile phase, the use of organic solvents is significantly reduced, the separation speed is faster, the peak shape is better, especially suitable for the preparation of high value-added products such as polypeptides, PDC, chiral polypeptides, etc., with the advantages of low carbon, safety and low cost.
- The system supports stack sampling, automated method development, atmospheric fraction collection, higher processing throughput, simpler post-processing, and rapid scale-up from analysis to preparation.
- Equipped with liquid chromatography accessories and consumables (high pressure and co...
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