(Synthesis processes and amounts)

Ｑ:Can Yamasa consider requests to synthesize a compound including the development of synthesis processes?

Ａ:We provide compounds, including process development, based on our many years of experience synthesizing nucleic acid related compounds.

Ｑ:Is it possible to synthesize a compound following specific synthesis processes provided from us?

Ａ:We accept requests for custom manufacturing using specific processes provided by clients. While we specialize in synthesizing nucleic acid related compounds, we also handle custom manufacturing for a partial process, such as a freeze-drying process under GMP control, apart from nucleic acid related compounds.

Ｑ:Are compound synthesis processes through enzymatic synthesis rather than chemical synthesis available?

Ａ:In addition to chemical synthesis, we specialize in enzymatic synthesis, allowing us to select the optimal synthesis process for each compound.

Ｑ:What is the overall process for requesting custom synthesis services?

Ａ:Once we receive your inquiry and, if necessary, complete a non-disclosure agreement, we will conduct a preliminary assessment study of the requested compound. If we determine that we can provide services for the requested compound, we will then provide an offer.

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(About the compound types we synthesize)

■Small molecule pharmaceuticals

Ｑ:Do you synthesize small molecule active pharmaceutical ingredients (APIs)?

Ａ:We have been manufacturing small molecule APIs of nucleic acid related compounds since 1971. We have developed an entire business specialized in nucleic acid related compounds backed by extensive experience. Our manufacturing offerings include not only APIs but intermediates as well.

Ｑ:Can you synthesize nucleic acid-based APIs that are chemically modified, such as at the sugar, nucleobase, or phosphate position?

Ａ:We are highly experienced in chemical modifications of nucleobases, sugars, and phosphates, which are the building blocks of nucleotides.

More details

Ｑ:Do you synthesize small molecule active pharmaceutical ingredients (APIs) for investigational drugs?

Ａ:We offer manufacturing of small molecule compounds used in drug discovery and APIs under GMP control used in clinical trials in accordance with clients' development stages. We also provide services to prepare regulatory applications and develop analytical methods.

Ｑ:Do you provide services to manufacture commercial small molecule active pharmaceutical ingredients (APIs)?

Ａ:We have commercial-scale facilities for small molecule APIs and a global supply structure operated under quality and manufacturing control system that comply with global regulations. We constructed a new GMP-compliant production facility in 2022 to further enhance our production capacity for small molecule APIs.

More details

■Middle molecule pharmaceuticals

Ｑ:Do you synthesize middle molecule active pharmaceutical ingredients (APIs)?

Ａ:We manufacture oligonucleotides, which are APIs for oligonucleotide therapeutics. Please note that we do not manufacture peptide APIs.

Ｑ:Can you synthesize new modified amidite monomers?

Ａ:We provide custom synthesis and process development for new modified amidite monomers based on our many years of experience synthesizing nucleic acid related compounds. We also manufacture and market LNA amidites.

Ｑ:Can you synthesize oligonucleotide APIs using new modified amidite monomers?

Ａ:Utilizing our small- to large-scale oligonucleotide synthesizers, we offer comprehensive manufacturing services that cover synthesis of new modified amidite monomers and oligonucleotides.

Ｑ:Can you synthesize oligonucleotide APIs for investigational drugs?

Ａ:We offer manufacturing of oligonucleotides used in drug discovery and oligonucleotides APIs under GMP control used in clinical trials in accordance with clients' development stages. We also provide services to prepare regulatory applications and develop analytical methods.

Ｑ:Do you offer manufacturing services for commercial oligonucleotide APIs?

Ａ:We have the commercial-scale facility for oligonucleotide APIs and a global supply structure operated under quality and manufacturing control system that comply with global regulations.

■Other chemical products

Ｑ:Do you offer fine chemical synthesis?

Ａ:We can study synthesis for nucleic acid related compounds. We manufacture and market API starting materials, life science related materials (such as materials for PCR), food additives, raw materials for cosmetics, and other products for industrial use.

Ｑ:Do you offer synthesis services for compounds other than nucleic acid related compounds?

Ａ:While we have an entire business specialized in nucleic acid related compounds, we also accept requests for other types of compounds for which we have the specialized technologies, such as those used for phosphorylation processes.

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Ｑ:Can we request compound synthesis starting from the stage of drug target searches for diseases?

Ａ:Although we do not provide compound libraries, we can perform synthesis starting from the search stage depending on the compound.

Ｑ:Can we request the development of scale-up processes of APIs?

Ａ:Utilizing our manufacturing facilities dedicated to scale-up and Yamasa's unique experience and original technologies, we offer the development of scale-up processes of APIs.

Ｑ:Can we request the development of API analytical methods?

Ａ:We support the development of appropriate analytical methods for nucleic acid related compounds using the state-of-the-art equipment (such as UPLC, LC-MS, etc.) and through the extensive experience of our analytical chemists.

Ｑ:Can we request the preparation of regulatory applications for pharmaceuticals?

Ａ:We provide regulatory support for pharmaceuticals during all development stages. We have a broad range of registration and maintenance experience in Japan, USA, EU and Asia such as:

• Drug Master File (DMF)
• CMC quality module documentation in CTD format for Investigational New Drug Application (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA)
• Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)

Ｑ:Can we request API manufacturing following standards such as the ICH Guidelines?

Ａ:Regarding manufacturing of APIs and intermediates, in addition to Japan's GMP standards, our procedures comply with global quality assurance systems following the ICH Guidelines and the PIC/S GMP Guide. We also undergo inspections by regulatory authorities in Japan and foreign countries, including the U.S. FDA.

Ｑ:Do you provide APIs to clients outside Japan?

Ａ:We have been providing APIs to clients outside Japan since the 1970s and handle export operations in-house.

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Ｑ:What kind of food additives do you handle?

Ａ:We manufacture and market five types of 5'-nucleotides as food additives: adenylic acid (5’-AMP), inosinic acid (5’-IMP), uridylic acid (5’-UMP), cytidylic acid (5’-CMP), and guanylic acid (5’-GMP). In addition to marketing these food additives globally as key ingredients for infant formula, we can also study to supply these for new uses as requested.

Ｑ:What food additive quality assurance systems do you follow?

Ａ:We comply with ISO 9001 and FSSC 22000 requirements for food additives. Our food additives are also Halal and Kosher certified.

Ｑ:What production processes do you use to manufacture food additives?

Ａ:We manufacture 5’-nucleotides as food additives by an enzymatic RNA degradation method with nuclease P1, a degrading enzyme discovered by Yamasa.

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Ｑ:What types of fine chemicals do you manufacture?

Ａ:We specialize in nucleic acid related compounds. We manufacture and market API starting materials, life science related materials (such as materials for PCR), food additives, raw materials for cosmetics, and other products for industrial use.

Ｑ:What fine chemical quality assurance systems do you follow?

Ａ:We are ISO 9001 certified. Our food additives are also Halal and Kosher certified.

Ｑ:What production processes do you use to manufacture fine chemicals?

Ａ:We manufacture 5'-nucleotides using an RNA degradation process. When manufacturing other nucleic acid related compounds, we apply optimal processes utilizing chemical and enzymatic synthesis.

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Ｑ:What types of collaborative research does Yamasa conduct?

Ａ:Our collaborative research mainly deals with synthesis processes for nucleic acid related compounds. Our track record of collaborative research is highly extensive, such as projects dealing with drug discovery research. Examples include synthesis of modified nucleosides (sugar modified, nucleobase modified) that are likely biologically active, and synthesis process development for modified nucleoside phosphoramidites with potential as therapeutic oligonucleotide materials.

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