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Abraxis

abraxisbio.com

Founded Year

2007

Stage

PIPE | IPO

About Abraxis

Abraxis BioScience is a biotechnology company focused on therapeutics and core technologies that offer more effective treatments for cancer and other critical illnesses. The Abraxis portfolio includes the protein-based nanoparticle chemotherapeutic compound (ABRAXANE) which is based on its tumor targeting system known as the nab Technology platform.

Headquarters Location

11755 Wilshire Blvd., 20th Floor

Los Angeles, California, 90025,

United States

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Expert Collections containing Abraxis

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Abraxis is included in 1 Expert Collection, including Cancer.

C

Cancer

4,784 items

Pharmaceutical and biotechnology companies with cancer therapy drug candidates.

Abraxis Patents

Abraxis has filed 160 patents.

The 3 most popular patent topics include:

  • Experimental cancer drugs
  • Antineoplastic drugs
  • Oncology
patents chart

Application Date

Grant Date

Title

Related Topics

Status

10/28/2020

11/15/2022

Autoimmune diseases, Signal transduction, Human proteins, Immunosuppressants, Transcription factors

Grant

Application Date

10/28/2020

Grant Date

11/15/2022

Title

Related Topics

Autoimmune diseases, Signal transduction, Human proteins, Immunosuppressants, Transcription factors

Status

Grant

Latest Abraxis News

FDA Slaps Abraxis Plant With Warning Letter for Contamination Issues

Nov 10, 2022

November 9, 2022 Because Abraxis Bioscience, a subsidiary of Celgene, didn’t fix the problem of multiple media fill failures along the aseptic processing line at its biologics plant, the FDA hit the Phoenix, Ariz., company with a warning letter. Abraxis makes the chemotherapy Abraxane (paclitaxel). The FDA noted that the company reported a very high number of contaminated units after conducting a media fill on April 20, 2021. Abraxis said 10 different microbes were identified from samples of contaminated units, including spore forming, vegetative, gram-negative and gram-positive microbes. The company’s investigation attributed the root cause to a damaged valve that was contaminated during equipment cleaning. “The investigation indicated that the valve harbored such excessive bioburden that it apparently enabled numerous bacteria to survive the subsequent filling equipment sterilization cycle, and the contaminated valve then caused the extensive contamination of units during the media fill,” wrote FDA. The agency said the company’s investigation after the discovery failed to adequately address how not only spore forming microbes, but also vegetative microbes presumably survived the company’s validated sterilization cycle. Four months later, on July 12, 2021, said FDA, Abraxis conducted a repeat media fill, which also revealed multiple contaminated units. The agency said the company attributed the root cause of the failure to personnel gowning, poor disinfection of the inner Restricted Access Barrier System (RABS), and contaminated forceps used in the RABS. The company’s subsequent corrective and preventive actions (CAPA) “did not sufficiently expand to more holistic remediation of the root causes, including but not limited to, ensuring a comprehensive evaluation of the frequency, specificity, sufficiency, and robustness of your disinfection and decontamination program for the RABS and the surrounding cleanroom(s),” wrote the agency. On October 5, 2021, said FDA, Abraxis conducted a media fill as part of its process improvement and again observed a high number of contaminated units. The company said the bacterial contamination was introduced via apparatus used for sample collection. Notably, said the agency, this time the company’s process incorporated multiple pieces of disposable equipment on its sterile processing line rather than traditional reusable equipment. The investigation was insufficient, said FDA, adding that the investigation lacked sufficient evaluation of the ruggedness of the disposable systems. On November 5, 2021, the company conducted a media fill as part of qualification of its system, and observed one turbid vial, attributing the contamination to inadequate disinfection of the area below the work surface that contaminated the pump apparatus. These media fill contaminations “indicate your aseptic manufacturing operations were not in control,” said FDA. The warning letter directed the company to take multiple actions to correct the problems, including providing a comprehensive risk assessment of all contamination hazards. Among other steps, the agency called for a detailed remediation plan with timelines, a thorough evaluation of the suitability of each apparatus used, and the hiring of a current good manufacturing practice consultant. Abraxis didn’t respond to a request for comment. Read the warning letter here: www.fdanews.com/11-09-22-AbraxisBioscienceWL.pdf . — Suz Redfearn

Abraxis Frequently Asked Questions (FAQ)

  • When was Abraxis founded?

    Abraxis was founded in 2007.

  • Where is Abraxis's headquarters?

    Abraxis's headquarters is located at 11755 Wilshire Blvd., 20th Floor, Los Angeles.

  • What is Abraxis's latest funding round?

    Abraxis's latest funding round is PIPE.

  • Who are the investors of Abraxis?

    Investors of Abraxis include Avalon Ventures.

  • Who are Abraxis's competitors?

    Competitors of Abraxis include Lipella Pharmaceuticals, Molmed, Threshold Pharmaceuticals, Dendreon, Algae Biosciences and 13 more.

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