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IND Application Support: M4Q Modular Document Preparation Prepares Module 2 quality summaries and Module 3 application documents per ICH M4Q (R1), providing the Chemical Drug Phase I Clinical Trial Application Pharmaceutical Research Information Summary Table to accelerate IND approvals.
The Melting Temperature (Tm) Test
The melting temperature (Tm) of oligonucleotides refers to the temperature at which 50% of the oligonucleotides form double - stranded structures with their perfectly complementary strands, while the other 50% remain free in the solution. Tm is extremely important for many techniques in molecular biology, such as PCR, Southern blotting, in - situ hybridization, etc.
Nucleic acid drugs, also known as nucleotide drugs, are oligoribonucleotides (RNA) or oligodeoxyribonucleotides (DNA) with different functions, mainly exerting their effects at the genetic level. Some nucleic acid drugs have a double - helix structure. When the temperature rises, the hydrogen bonds break up and the double - stranded structure disintegrates into single strands. The temperature at which the proportion of double - strands and single - strands is equal is the melting temperature (Tm). It is an indicator for characterizing the thermal stability of nucleic acids and depends on the base sequence, nucleic acid concentration, mismatches, etc. Nucleic acids have an ultraviolet absorption peak near 260 nm, and the absorption value increases during the "melting" process. The Tm analysis system determines the Tm value by measuring the change in absorbance.
Formulation Development and Production
The formulation development and production of Hitston is part of an integrated small nucleic acid drug CDMO platform. It has three aseptic formulation production workshops that comply with cGMP standards and has undergone multiple audits by the NMPA, FDA, and the European Union. A single - use liquid - dispensing system is adopted. The filling system is equipped with both vial filling and pre - filled syringe filling production lines.
The production environment classification for the vial filling and stoppering machine is B + A grade, and operations such as filling and stoppering are completed within isolators. The batch quantity can be flexibly adjusted according to requirements, with a minimum batch of 500 ml. The liquid - dispensing system of this production line is equipped with a 100L liquid - dispensing tank, a 60L transfer tank, and a 100L aseptic receiving tank. Each tank can be weighed online, temperature - controlled, and protected by nitrogen filling. Aseptic feeding methods can also be used for feeding materials to meet different process requirements.
The filling machine is equipped with 6 pump heads, and the production speed can reach 120 bottles per minute. Generally, the filling volume control range can reach ±3%. The pre - filled syringe filling machine is equipped with 10 filling needles and an in - line weighing device for sampling inspection. Generally, the filling volume control range can reach ±5%, and the filling volume range is 1 - 10 ml, meeting the production requirements for nucleic acid formulations in vial or pre - filled syringe packaging.
The professional team conducts rigorous quality control from the initial process assessment to the production stage, and monitors and records in detail throughout the process in accordance with GMP regulations. Its complete cGMP management system provides strong support for the production of high - quality nucleic acid formulations, ensuring project delivery in all aspects and throughout the entire cycle.
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