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# CBER Advanced Technologies Team Created: Report
- URL: https://www.fdaweb.com/cber-advanced-technologies-team-created-report/
- Published: 2021-02-08T12:00:00.000Z
- Updated: 2026-09-14T16:45:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148610

Despite an all-hands-on-deck approach to address Covid-19 issues in 2020, CBER was also able to squeeze out its new [CBER Advanced Technologies Team](https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-team-catt?ref=fdaweb.com) (CATT) to “address the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics,” according to Center director **Peter Marks**. “The goal of this program is to promote a more robust manufacturing process with fewer interruptions in production, fewer product failures, and greater assurance that the biologic products will meet clinical performance expectations,” he said in the just-released [*FY 2020 Report from the Director*](https://www.fda.gov/vaccines-blood-biologics/fy-2020-report-director?ref=fdaweb.com). CBER awarded several research grants last year to support projects to study and recommend improvements for advanced manufacturing.

According to Marks’ report, [CBER’s Advanced Technologies Program](https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-program?ref=fdaweb.com) coordinated the following activities:

- CATT received 18 requests for feedback and meetings with CBER staff from prospective innovators and developers of advanced manufacturing technologies.
- CBER awarded one contract (through the Broad Agency Announcement mechanism) to identify critical quality attributes of cell and gene therapies using a multi-omics approach. CBER also awarded two grants to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of adeno-associated virus vectors.
- CBER and the International Symposium on the Continuous Manufacturing of Pharmaceutical 9/2020 co-hosted a webinar, “Integrated and Continuous Biologics Pharmaceutical Manufacturing**,”** with the objective to communicate how integrated and continuous bioprocessing is a comprehensive approach to assure quality, reduce cost, enhance speed to patients and maximize flexibility in addressing national needs and discuss barriers to implementation and strategies to address them.

Last year also saw CBER advancing its efforts to allow patient engagements. The report says that Center staff attended more than a dozen patient-focused drug development meetings including those for rare diseases such as Krabbe Disease and Pompe Disease. They attended FDA/National Organization for Rare Disorders patient-led rare disease listening sessions requested by patient groups to better understand patient and caregivers’ perspectives on disease burden, treatment preferences, and clinical trial design. And staff participated in meetings with EMA/FDA patient engagement and rare disease clusters, it says.

Additionally, Marks notes that five BLAs were approved for the following novel biologic products:

- [MenQuadfi](https://www.fda.gov/vaccines-blood-biologics/menquadfi?ref=fdaweb.com) (meningococcal (groups A, C, Y, W) conjugate vaccine) — indicated for active immunization for the prevention of invasive meningococcal disease caused by *Neisseria meningitidis* serogroups A, C, W, and Y.
- [Audenz](https://www.fda.gov/vaccines-blood-biologics/audenz?ref=fdaweb.com) (influenza a (H5N1) monovalent vaccine, adjuvanted) — indicated for preventing the influenza A virus H5N1 subtype contained in the vaccine.
- [Palforzia](https://www.fda.gov/vaccines-blood-biologics/allergenics/palforzia?ref=fdaweb.com) (peanut (*Arachis hypogaea*) allergen powder-dnfp): Indicated for mitigating allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
- [Tecartus](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus-brexucabtagene-autoleucel?ref=fdaweb.com) (brexucabtagene autoleucel): A CD19-directed genetically modified autologous T cell immunotherapy indicated for treating adult patients with relapsed or refractory mantle cell lymphoma.
- [Sevenfact](https://www.fda.gov/vaccines-blood-biologics/sevenfact?ref=fdaweb.com) (coagulation Factor VIIa (recombinant)): Indicated for treating/controlling bleeding episodes in hemophilia A or B patients