• Freedom to Operate – Solid phase custom manufacture

    First and foremost, Girindus has executed license agreements that give us the freedom to operate solid phase oligonucleotide manufacturing processes utilizing technologies covered under certain patents. The licenses cover key steps in the manufacturing processes to be used in the manufacture of all major classes of oligonucleotides (including the steps of detritylation, activation of phosphoramidites, sulfurization and an amine wash for deprotection), including the rights for manufacture of commercial product.

    Secondly, we believe that your process, as well as your product, belongs to you and not to us. Our understanding as a CMO is that our clients will stay with us because they value our services and performance, not because we are controlling their IP.

    Therefore we want to make it clear: Girindus will not claim any rights to IP arising from a process development project with a client, no matter if it’s process or method related.

    For detailed information please contact our Business Development Team.

  • FDA Inspection

    Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received unannounced systems audits by the FDA in 2007 and in 2010. The audits included small molecule and oligonucleotide manufacturing areas. The results were exemplary:  no form 483 and no objectionable findings.  

    Our FDA registration number is: 3003270485

    For detailed information please contact our Business Development Team.

  • CMC Documentation

    Our QA team has over 50 years of cumulative experience, with a proven compliance record in the pharmaceutical industry and can support clients with CMC, DMF and IND submissions.

    For additional information, please contact our project management team.

  • Quality and Compliance

    Excellent Compliance Track Record –  The compliance track record at our facility in Cincinnati, Ohio, USA is excellent, demonstrated by numerous successful inspections by FDA and by our customers. 

    Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received in 2007 and 2010 unannounced systems audits by the FDA that included small molecule and oligonucleotide manufacturing areas. The result of these audits were excemplary: no form 483 and no objectionable findings.


    As a manufacturer for the life science industry, Girindus is fully committed to the current Good Manufacturing Practices (cGMP) for Active Pharmaceutical Ingredients as defined in ICH Q7. Our Quality Policy and quality systems incorporate the principles defined in ICH Q7 along with national and International regulations to ensure sustainable compliance in the US, European and Asian regions.

    Our Quality Assurance/Regulatory Affairs team has over 50 years of cumulative experience, with a proven compliance record in the pharmaceutical industry and can provide regulatory support for the Chemistry, Manufacturing and Controls (CMC) Section for US and International regulatory submissions (DMF, IND, CTA, NDA). 

    Quality Assurance Capabilities

    • SOPs 
    • Batch Records 
    • Certificate of cGMP compliance
    • Deviation Investigations 
    • Audits – internal, external, client and FDA inspections
    • Complaints
    • Corrective and Preventive Action Program
    • GMP Training
    • Change Control
    • Supplier Approval
    • Validation and Qualification Program

    Regulatory Affairs Capabilities

    • Drug Establishment Registration (US FDA)
    • CMC narratives for US and European Submissions
    • Interaction with regulatory authorities
  • Project Management

    Our experienced project management team is led by a PhD chemist with 10 years of pharma experience in analytical development, quality control and manufacturing. The team is comprised of chemists and chemical engineers with experience in managing complex, multi faceted projects with aggressive timelines. 

    • Flexibility - We understand the need to be flexible in early phase clinical projects and are able to respond in a rapid manner to changing project requirements.
    • Dedicated Project Management Organization - Our team of project managers work closely with you before, during and after the project. We understand your expectations and project needs and we anticipate your future needs with respect to regulatory requirements. Accurate project tracking facilitates realization of all project priorities.
    • Timely and Accurate Communications - Prior to the start of project, our team of project managers, technical specialists and Quality Assurance professionals meet with the client to discuss the program. During the execution of the program, the team provides project updates through regular telephone conferences. Customers are more than welcome to send representatives to the facility during the execution of the program.

     

  • Small Molecules

    We offer our clients a broad range of synthesis and services for the development of small molecules / NCE through the early pre-clinical stages up to the commercialization of the API for volumes of 100’s of grams to 10’s of kilograms. We also have access to a full scale multipurpose cGMP production facility in Giraud, France.

    Our project management team and expert associates take great care to provide our clients with honesty, flexibility, responsiveness and customer intimacy.

    Our state-of-the-art plant in Cincinnati, Ohio, USA, focuses on high quality, flexibility and speed and is suited for the preparation of grams up to 10’s of kilograms of APIs. We operate both small-scale synthesis and kilo laboratories, an integrated pilot plant facility with computer monitored reactors and extensive equipment for downstream processing, including preparative HPLC and flash chromatography at the kilogram scale.

    Girindus is your partner of choice if:

    1. You need a rapid Screening and Process Development Triage to take a medicinal chemistry route and produce kilogram quantities of an API with an aggressive timeline. 
    2. You require a high level of Quality Assurance to assist in cGMP documentation to support regulatory filings. 
    3. You want to run a fast and efficient project from pre-clinical to phase II and transfer the process after out- licensing the drug. 
    4. Your annual need for product is in the 10’s of kilos.
  • Radiolabeling

    Our site in Cincinnati provides 1000 square-foot laboratory dedicated to "cold" development chemistry and four dedicated individual radiochemistry cells. 

    Various analytical tools such as radio- TLC, HPLC, PDA’s, in-line radioactive flow cells, NMR and scintillation counting are available to analyze and release your radiolabeled products. 
    We hold licenses for the use of carbon-14, tritium and iodine-125. 

    Our dedicated experts are experienced in all phases of radiochemistry from synthesizing reactive intermediates to performing complex multi-step radiosynthesis.

  • Oligonucleotides

    As a customer-driven company we offer our pharmaceutical clients comprehensive skills, ranging from process development, analytical method development, radiolabeling, cGMP compliant scale-up and manufacturing of active ingredients, as well as regulatory support. 

    We can provide oligo’s at scales from 10’s of mg to kilos for applications from pre-clinical research and toxicology studies to clinical trials and throughout the commercial life of your product. 

    Moreover, Girindus is the only company providing expertise in both oligonucleotide and small molecule API’s combined with the unique offering of radioactive labeling. And with our sister company Peptisyntha, we can offer oligonucleotides AND peptides.  All this makes us a unique one-stop-shop CMO to cover all our customer’s needs.

    We operate commercial scale oligonucleotide production at our FDA registered and inspected site in Cincinnati, Ohio, USA, which is also home to our laboratories and pilot plant facilities. 

    We offer our clients a broad range of synthesis and services for the development of oligonucleotides through the early pre-clinical stages up to the commercialization of the drug substance and beyond. Our project management team and expert associates take great care in working with our clients with empathy, flexibility, responsiveness and customer intimacy.

    RELIABILITYYou will be a member of a joint team.
    EXPERTISEYou are sure to be in "good hands" with our experts and project managers.
    COMMUNICATIONYou receive clear messages right from the start, and all the way through your collaboration with Girindus.
    EMPATHYYour needs are understood from pre-clinical stages through to full commercialisation of your product.
    RESPONSIVENESSYou receive quick and accurate answers and support.