Your Trusted Partner in Biologics Innovation
Our Experience.
Collaborating on Your Vision.
Tanvex is where innovation meets expertise in biopharmaceutical manufacturing for both mammalian and microbial biologics and biosimilars. With a shared experience alongside biologics innovators, our team is committed to providing transparent and collaborative guidance throughout every step of your program.
Our Experience Speaks Volumes
Tanvex boasts an experienced team that has successfully advanced biologics from Investigational New Drug (IND) applications to Biologics License Application (BLA) submissions. This wealth of experience has solidified our foundation of regulatory expertise, allowing us to understand and empathize with each client’s unique position in the biopharmaceutical landscape and help advance their product through clinical phases to commercialization.
Quality Management Maturity
Our commercial experience has also allowed us to build and refine a mature Quality Management System (QMS) having been through multiple regulatory inspections for drug approval to become GMP compliant and commercial-ready. This mature QMS ensures that every phase of the product development process is backed by solid procedures, careful risk evaluations, and thorough quality checks.
Embracing a mature QMS not only ensures consistent delivery of safe and effective pharmaceuticals, but also demonstrates our commitment to maintaining quality excellence despite ever-evolving regulations and scientific landscapes. Quality is the glue to all of Tanvex’ development and manufacturing activities, setting the highest standards for our operations from development to clinical and commercial GMP manufacture.
Scientific Artistry Driving Innovation
Our scientists are not just experts – they’re creative minds that excel in both process and analytical development. This innovative approach brings game-changing value to the table by optimizing processes and characterizing products in ways that drive efficiency and quality.
Our team’s dedication to innovation and excellence is evident. Expertise spanning microbial and mammalian capabilities, and regulatory gives us the flexibility to support both biosimilar and novel antibody therapeutics. This versatility, combined with our analytical prowess, positions Tanvex as a formidable partner in the biopharmaceutical arena. Our stand-out analytical capabilities enable us to support our customers comprehensively, ensuring the highest standards of quality and efficacy.
A Seamless Extension of Your Team
We understand the innovator perspective, having been on that side of the outsourcing partnership ourselves. This firsthand experience drives our commitment to delivering gold standard customer service, supporting you every step of the way.
We take pride in working transparently and collaboratively, seamlessly integrating ourselves as an extension of your team. As partners, we walk shoulder-to-shoulder with you, dedicated to advancing your product optimally and achieving your goals.
From pre-clinical to commercial manufacture, Tanvex possesses the knowledge and expertise required to guide a biologic through every stage of development. Our team’s familiarity with regulatory requirements and FDA inspections ensures a smooth and compliant journey.