Services

  1. Sterile Drug Product Development And Manufacturing 7/19/2024

    The Pharma Expanse network currently spans across 9 manufacturing sites in 5 countries and can support discovery, preclinical, clinical and commercial programs for New Chemical Entities (NCEs). Pharma Expanse has an innovative business model that does not add additional costs to your project. Review our network's regulatory starting material capabilities below and contact us to simplify your outsourcing solutions.

  2. Exosomes 5/31/2024

    Exosomes are nano-sized vesicles that enable unique intercellular communication by transferring DNAs, microRNAs, non-coding RNAs, and lipids.

  3. Cell And Gene Therapy 5/31/2024

    Mycenax offers a comprehensive, one-stop CDMO service covering a broad spectrum of Allogeneic Cell and Gene Therapy (CGT) Products. We are committed to delivering total solutions that facilitate process development and GMP manufacturing of innovative CGT products, enabling our clients to expedite their products to market through our state-of-the-art, scalable closed-process platforms featuring automated and modular workflows. Mycenax's highlighted solutions include the provision of streamlined allogeneic cell sources as starting materials, ensuring our clients embark on their product development journey with the right cells.

  4. Antibody-Drug Conjugates 5/31/2024

    Antibody drug conjugates (ADCs) are the emerging class of anti-cancer therapeutic drugs. ADCs combine an antibody capable of recognizing cancer cells and cytotoxic small-molecule drugs via cleavable or non-cleavable linkers, thereby transforming the 3-unit combination into a targeted therapeutic drug for cancer treatment. In recent years, ADCs have rapidly developed and there are not only more than 14 approved drugs on the market but also many investigational drugs undergoing clinical trials. Furthermore, ADCs have shown potential for treating various diseases beyond cancer, such as Autoimmune disorders, Infectious diseases, Inflammatory conditions and so on.  

  5. Plasmid DNA 5/31/2024

    At Mycenax, our microbial team is dedicated to providing solutions for plasmid DNA manufacturing, including long terminal repeat (LTR)-containing plasmids, such as lentiviral plasmids, etc., for gene and cell therapy developers. Leveraging our dedicated microbial lab and GMP microbial production line, we are capable of offering plasmid manufacturing services for projects in pre-clinical, IND application, and clinical phases.

  6. PIC/S GMP Production 5/31/2024

    Mycenax’s state-of-the-art biomanufacturing site is PIC/S GMP certified. Our highly qualified and well-trained team routinely manufactures high-quality biopharmaceutical products by mammalian cell culture and microbial fermentation processes. We continuously invest in our technologies and infrastructure to ensure that we constantly meet your evolving needs of today and tomorrow.

  7. Analytical Methods 5/30/2024

    Due to the complexity of the drug structure, it is necessary to provide accurate and stable test results through suitable analytical methods. In addition, conducting long-term product quality characteristics tracking is essential to make a correct, comprehensive judgment on drug quality.

  8. Process Development 5/30/2024

    Learn how Mycenax is equipped to support process development for a wide range of therapeutic modalities.

  9. Cell Line Development 5/30/2024

    Mycenax develops and establishes high-quality cell lines for various host cell and product types. We are the experts for all cell line development activities, from vector construction to generating cell banks for GMP manufacturing following ICH and global regulatory requirements. We also support early-stage material generation for proof-of-concept studies or preclinical development programs.

  10. Oral Solid Dose Manufacturing 5/30/2024

    At Alcami, we provide cGMP manufacturing services that scale with your development and approval milestones, ensuring a seamless transition from clinical to commercial supply.