October 2024

October 2024

BIOTHERAPIES NEWS: Highlights and Top Stories


BIOTHERAPIES AT AABB: Community and Association News

Cell Notes: A Monthly Column by Christina M. Celluzzi, PhD, MS, CABP(H), director, biotherapies at AABB

Reflections on the 2024 AABB Annual Meeting?

I can’t say this enough: one of the most remarkable aspects of being part of AABB is the sense of community that uplifts colleagues who give their time and intellect to make the world safer for patients and donors. This was on full display at the 2024 AABB Annual Meeting, which, in a word, was “wow.”

With the backdrop of Houston, the AABB Annual Meeting embodied that sense of camaraderie and shared purpose. Given the extensive positivity, how could I not write something about it? There was so much happening, between scientific sessions, networking and face-to-face conversations, that the feeling will linger throughout the year. Sessions were filled with ground-breaking research and insightful discussions that left us inspired and motivated. More than a gathering of scientific minds, there was a profound sense of connection. I met many incredible individuals, each with their own captivating story.

I encourage you to explore the program and see what you may have missed if you attended, and discover the hot topics presented if you are thinking of joining us next year!

Continue reading this month’s “Cell Notes” column, now available on the AABB website.


AABB Releases CABP Exam Prep Bootcamps?

AABB is pleased to announce the release of a series of certified advanced biotherapies professional (CABP) exam prep bootcamps to help candidates prepare for AABB’s CABP exam.?

Developed by a diverse panel of credentialed CABPs and experts in the biotherapies field, each pre-recorded bootcamp focuses on one of the seven domains covered in the CABP exam. Each bootcamp also includes the presenter's handouts for future reference and a downloadable audio file. The complimentary "Getting Started with CABP" bootcamp includes additional study aids: a self-assessment tool, study plan tool and a study group planner.?

To receive complimentary access to the full bootcamp series, AABB encourages candidates to submit a CABP exam application with supporting documentation and the application fee. AABB will send candidates with a completed and approved CABP exam application access instructions via email.?

Individual bootcamps are also available for purchase at $39 (members) or $49 (nonmembers), with a discounted bundle for $220/$275, respectively.?

For more information on AABB’s CABP, eligibility and how to apply, visit AABB’s CABP web page or Becoming a CABP web page.??

In related news: CABP Bulk Pricing?

AABB is now offering CABP discounted bulk pricing – ideal for organizations with multiple employees seeking CABP certification.?

Normally priced at $395 for AABB members and $495 for non-members, the CABP institutional discount offers CABP exam fees at a 15% bulk discount rate for purchases of four or more application registrations.?

AABB developed this program in response to increasing demand from organizations in the field, and to better support them in expanding the qualifications of their workforce.?

Four or more applicant registrations must be provided at the same time to qualify for the CABP discount. The price per applicant will be determined by the institution’s AABB membership status. Price per applicant reflected below. ?

For more information, please visit the CABP for Organizations web page.?


CGT Pharmacy Standards Open for Public Comment?

AABB is pleased to introduce the proposed first edition of Cell and Gene Therapy Standards for Pharmacy, available for public comment through Dec. 16. This new standards program from AABB is designed to ensure the highest level of quality and safety for cell and gene therapy (CGT) products. ? ?

As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within pharmacy.????

Developed through a committee of diverse academic and industry stakeholders and drawing on AABB’s expertise and history in quality system creation, AABB’s Cell and Gene Therapy Standards for Pharmacy will guide pharmacies in the receipt, storage, handling and dispensing of these therapies. The program intends to assist pharmacy programs in enhancing patient safety by filling a critical gap in accreditation while addressing business risks by ensuring product integrity while in possession of a pharmacy.??

The Cell and Gene Therapy Standards for Pharmacy Committee encourages all interested individuals to submit comments through Dec. 16. The draft first edition of standards will be finalized after the comment period has concluded. The committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions. ? ?


#AABB24: More Biotherapies Highlights?

  • AABB24: Return of the Biotherapies Pavilion

Back by popular demand, the Biotherapies Pavilion is a specially designed networking space within the Exhibit Hall to provide biotherapies companies with new and curated opportunities to connect with key audiences and gain access to all that the AABB Annual Meeting has to offer. Participating organizations this year included:?

雅培 , an AABB corporate partner and presenting sponsor of the 2024 Biotherapies Pavilion.?

American Red Cross Cell and Gene Therapy Solutions, a provider of cell and gene therapy source materials and collection services to support clinical trials and commercial therapies.?

Dark Horse Consulting Group Inc. , a specialized firm that provides expert consulting services to the cell and gene therapy industry.?

Eurofins CellTx , an FDA-registered laboratory for screening human cells, tissues, and cellular- and tissue-based products (HCT/Ps).?

Gulf Coast Regional Blood Center , an AABB institutional member based in Houston, is an independent community blood center that supports one of the nation's most diverse cities. The center also operates Cellular Life Solutions to support the growing demand for high-quality human cellular starting material.?

Health-ISAC , the Health Information Sharing and Analysis Center, is a nonprofit organization that connects health care security professionals globally to share actionable information and strengthen defenses against cyber and physical security threats.?

Nucleate Texas , a student-led global nonprofit empowering future biotech leaders by educating today’s academic trainees.?

Synatron Systems, a team of experienced software/hardware developers, designers and project managers with expertise in the development of sensory networks.

Versiti Inc. , an AABB institutional member based in Wisconsin focusing on blood collections and innovative blood solutions.?

Vitalant , an AABB corporate partner based in Arizona, is one of the nation’s largest nonprofit blood and biotherapies health care organizations.?

This year’s Biotherapies Pavilion schedule included expert-led open-mic sessions and an engaging discussion about AABB’s Certified Advanced Biotherapies Professional (CABP) Credentialing Program, hosted during the CABP Celebration Hour. During this discussion, attendees heard from three CABPs – Jennifer Chain, PhD, CABP ; Kevin Land MD ; and James Utley MSc, PhD, CABP, MLS(ASCP) – about how they prepared for the exam and discovered the latest resources available for candidates on their way to pursuing this esteemed certification.??

For the latest updates on upcoming opportunities for 2025, register your interest in biotherapies sponsorship and connection packages at the 2025 Annual Meeting , taking place October 25-28, in San Diego, CA.

  • AABB24: Book Launch: Getting Started in Processing for Biotherapies?

2024’s Biotherapies Pavilion in the Exhibit Hall was bigger than ever; on Saturday evening, one of the crown jewels was the launch of AABB’s new book Getting Started in Processing for Biotherapies, written by Joseph (Yossi) Schwartz , MD, MPH; Garrett Booth , MD, MS; Laura Connelly-Smith , BPharm, MBBCh, DM; Jeremy Jacobs, MD, MHS ; Ashley Angell Krull, Ph.D. ; Salyka Sengsayadeth, MD; and Ronit Slotky , PhD, MSc, CABP.?

Jeff Wren , AABB’s vice president of biotherapies, discussed the book with Schwartz, who opened with a quote from Dwight D. Eisenhower: “Plans are worthless; but planning is everything.” Wren asked questions that allowed Schwartz to elaborate on the components of the book and explain why it is an essential resource for anyone planning for a new or expanded biotherapies laboratory. The book outlines the major processes to be considered in doing so and shares how to move it through from conception to reality.?

At the end of this well-attended event, members of the audience got the opportunity to ask questions, many focusing on roadblocks and difficulties they have faced with getting a lab up and running. After that, they lined up to have Schwartz sign their book copies and chat casually with him about their experiences.

For more information on Getting Started in Processing for Biotherapies and other AABB publications, visit the AABB Store.?

  • AABB24: Cellular Starting Material Forum 2024?

This year’s forum on Cellular Starting Material (CSM) continued the important exchange of expert perspectives from CSM collectors and the developers who modify the CSM to create advanced therapies for a growing spectrum of patients. The forum was conversational—among the panelists themselves and with audience members. Read more about this year’s CSM forum on the AABB Newsfeed. ?

In related news: American Red Cross Cell and Gene Therapy Solutions Biotherapies Pavilion Spotlight Q&A

Ahead of this year’s #BioPavilion , AABB interviewed Colleen Maiden , executive director for Clinical Apheresis and Cell and Gene Therapy Solutions at American Red Cross , a participating organization in the Biotherapies Pavilion at the 2024 AABB Annual Meeting.??

"The American Red Cross Cell and Gene Therapy Solutions (CGTS) has had a longstanding partnership with AABB through our blood collection services, which dates back many years. This collaboration, rooted in ensuring the highest standards for blood collection and safety, naturally evolved as we expanded into the cell and gene therapy space." said Maiden.?
“Our mission is to provide comprehensive solutions to clients, including apheresis treatments, specialized collections and manufacturing services, by leveraging our physician, nursing and technical expertise. These strengths, coupled with the power of the Red Cross brand and our expansive geographical reach, enable us to deliver tailored, life-saving products and services precisely when and where patients need them.”?
"What I find most rewarding about working in this field is knowing we're part of something that truly changes lives."?

Read the full interview to learn more about the American Red Cross Cell and Gene Therapy Solutions team.?

Thank you to the many attendees, exhibitors and volunteers who helped to make the 2024 AABB Annual Meeting such a success. We truly appreciated the chance to connect with the blood and biotherapies community. We look forward to seeing you all again next year in San Diego.?


AABB BIOTHERAPIES NEWSFEED: More Updates From the Field

Read more from the AABB Newsfeed , an essential resource offering the latest news, analysis, commentary and updates on critical topics for the blood and biotherapies community.


AABB MEMBERS ZONE: Biotherapies Resources and Events

October Issue of AABB News Focuses on the Evolution of Biotherapies???

The October issue of AABB News highlights the evolution of biotherapies and explores how blood facilities are becoming essential partners in developing and administering transformative therapies.?

This issue also features AABB’s newest biotherapies publication, Getting Started in Processing for Biotherapies, which outlines key considerations for planning a new or expanded biotherapies processing laboratory. In a new “White Coats” interview, Kevin Land, MD, CABP(H), shares his insights on the transformative potential of cell and gene therapies.?

Additional articles spotlight the 2024 AABB Memorial Award recipients, opportunities to serve on AABB committees and tips for staying active in cooler weather.?

Non-members may access a complimentary preview . ?


2024 Update on the Number of Clinical Trials Employing Perinatal Sources of Stem Cells Available Through the Parent’s Guide to Cord Blood??

Frances Verter, PhD ; Alexey Bersenev , MD, PhD; and Pedro Silva Couto , PhD, continue their tradition of issuing periodic updates on trends in clinical trials that employ perinatal sources of stem cells . This update extends our timeline through the end of 2023.

To learn more about this and cord blood banking, visit Parent's Guide to Cord Blood Foundation website . ?

In related news: Preparation for World Cord Blood Day Underway?

Annual World Cord Blood Day (WCBD) will be celebrated on Nov. 15. AABB, as an inspiring partner, participates in activities to highlight the use of cord blood, including discussions on its social media platforms. AABB has long supported the promise of cord blood, as demonstrated in its cord blood subsection , which was established in 2009 and continues to facilitate discussions on challenges, protocols and research findings that help to promote the value of cord blood and highlight its immunotherapeutic promise. AABB encourages readers to look for events in the coming months.?


AABB Update on Cellular Therapies Subsection Activities?

As a benefit , AABB members can enroll in AABB subsections, which meet monthly, to enrich their professional experience and to keep informed about happenings in the field of cellular therapy.?

Members of the subsections attending the AABB Annual Meeting had the opportunity to meet face-to-face. The joy of finally meeting in person was evident, as it allowed for deep, meaningful discussions that differed from the usual virtual group sessions. The warmth of personal interactions added a new dimension to conversations, creating a forum where members could share more freely. Our discussions were not only productive but also heartening, as members realized the potential to support each other in various domains of cell therapy and work together to develop projects that help the community.?


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Not an AABB Member?

Join AABB to gain access to essential benefits, including professional development opportunities, critical tools and resources, and opportunities to collaborate with leaders in the field. Be a part of a diverse community of health care professionals working to make transfusion medicine and biotherapies safe, available and effective worldwide. Find out more on the AABB website.

Ruston Lievore

Médico Patologista Clínico na HEMOES

3 周

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