BioFactura

BioFactura, Inc. is a biotechnology company based in Frederick, Maryland, specializing in the development and manufacturing of biosimilars, biodefense drugs, and novel medicines. The company utilizes its patented StableFast Biomanufacturing Platform to produce high-value, highly similar biosimilars and other biopharmaceuticals. This platform, which uses stable NS0 cell lines, allows BioFactura to develop biosimilar drugs that closely match branded products analytically. The company's focus includes creating biosimilars for autoimmune and infectious diseases, as well as biodefense drugs against threats such as smallpox and Ebola.

One of BioFactura's key products in development is a biosimilar to Janssen's Stelara, used to treat conditions like Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. In March 2021, BioFactura initiated a Phase I study comparing the pharmacokinetics of its Ustekinumab Biosimilar (BFI-751) to Stelara. The company is also working on a Smallpox Biodefense Therapeutic.

BioFactura has been expanding its operations to support its growth. As of March 2024, the company leased 17,520 square feet of space at Riverside Tech Park in Frederick, Maryland, consolidating its operations and expecting to employ over 50 professionals, including engineers, scientists, and quality control specialists. This expansion will allow BioFactura to perform additional product development, optimize processes, manufacture clinical drugs, and develop and validate assays needed for human use.

Key customers and partnerships

BioFactura has secured significant contracts and partnerships in the biodefense sector. In October 2023, the company received a USD 16 million contract option. Previously, in 2021, BioFactura was executing a USD 67 million contract with BARDA for the same therapeutic. The company's biodefense efforts also include work on drugs against Ebola.

In the biosimilars market, BioFactura is positioning itself to compete with larger pharmaceutical companies such as Amgen, Pfizer, Teva, and Sandoz. The company's focus on developing biosimilars for autoimmune and infectious diseases suggests a target market that includes healthcare providers and patients seeking more affordable alternatives to branded biologics.