September 2024

September 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

A Q&A with Yossi Schwartz, editor of Getting Started in Processing for Biotherapies?

Christina Celluzzi, PhD, MS, CABP(H) , PhD, MS, CABP(H), interviewed Joseph (Yossi) Schwartz , MD, MPH, CABP to discuss the release of AABB ’s new publication: Getting Started in Processing for Biotherapies.?

Why is there a need for this book, and what inspired you to write it??
The biotherapies field is expanding quickly, and many new professionals are entering the field in different settings, including academic, commercial and manufacturing. There is a common ground everyone needs to cover as a starting point; this book, Getting Started in Processing for Biotherapies, is meant to offer this ‘starting kit’ for processing. I was inspired to work on it because it enables sharing the knowledge we acquired to support newcomers in the field.?

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


In related news: AABB Releases New Publication: Getting Started in Processing for Biotherapies?

AABB is pleased to announce the publication of a new book, Getting Started in Processing for Biotherapies.?

Getting Started in Processing for Biotherapies outlines the major processes to consider in planning for a new or expanded biotherapies processing laboratory and shares how to bring plans from conception to reality. This new essential resource is intended to assist facilities and professionals at the beginning of a journey, covering foundational concepts and requirements and offering options to consider before acting.?

Specific topics include the type of work to be performed; quality management aspects; regulatory oversight; often overlooked support and ancillary services; and the very critical choices involving space, equipment, supplies and staffing. The narrative, illustrations, references for further study and helpful tools in the appendices are all intended to help readers get a solid start in the process of planning for a new program launch.?

The book is now available in both print and digital formats on the AABB Store.


AABB24: Biotherapies Highlights at the 2024 AABB Annual Meeting?

AABB is excited to welcome biotherapies enthusiasts and professionals from throughout the world to the 2024 AABB Annual Meeting , this year taking place Oct. 19-22 in Space City – Houston, Texas. Highlights of the upcoming meeting for biotherapies professionals include:?

  • “Sterility Testing for Cellular Therapies: Updates and Challenges. What should we be doing?” taking place 9:45–10:45 a.m. CT on Saturday, Oct. 19.?

  • “Enhancing Laboratory Competency with AI: Meeting AABB Standards for Cell Processing Facilities and Blood Banks,” taking place 11:15 a.m.–12:15 p.m. CT on Saturday, Oct. 19.?

  • “Critical Role of an Assay Lifecycle in Analytical Development for Cell and Gene Therapy Products,” taking place 1:45–2:45 p.m. CT on Saturday, Oct. 19.?

  • “The AABB Cellular Starting Material Forum: From Consent to Characterization – Enhancing Allogeneic Donor Practices,” taking place 9:30 –11 a.m. CT on Monday, Oct. 21.?

  • “Overview of Cell-Based Biologics Manufacturing as a Contracted Service Monday,” taking place 3:30–5 p.m. CT on Monday, Oct. 21.?

  • “Solve It! Scenarios in Apheresis and Cellular Therapy,” taking place 3:30 – 5 p.m. CT on Monday, Oct. 21.?

  • “Beyond CAR T: Non-Conventional Applications of CAR Technology in Biotherapies,” taking place 8:30-10 a.m. CT on Tuesday, Oct. 22.?

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 2024 AABB Annual Meeting has to offer.??

Returning to the Biotherapies Pavilion this year are industry expert open-mic conversations – a highlight from the 2023 meeting. AABB is excited to announce the schedule for this year’s 45-minute open-mic sessions has now been confirmed and will feature:?

Find out more about these events on the AABB website.


In related news: AABB to Offer Limited Virtual Access Option for the 2024 AABB Annual Meeting

AABB is pleased to announce a limited virtual access registration option for those who are not able to attend the 2024 AABB Annual Meeting in person. Those who register for this option will be able to live-stream 15 selected sessions throughout the four-day AABB Annual Meeting. Virtual attendees will also have the ability to participate in the question-and-answer periods and audience polling of the selected sessions through the 2024 AABB Annual Meeting app.

In addition to access to the select sessions, limited virtual access registration also includes:

  • the ability to earn and claim 15+ continuing education/medical credits (through Nov. 21, 2024)
  • access to the virtual poster hall with 400+ scientific posters
  • the opportunity to purchase the on-demand package with 100+ recorded sessions from the in-person Annual Meeting (to continue to earn and claim credit from Nov. 22, 2024, to Dec. 31, 2026).

Learn more about limited virtual access registration on the AABB website.


AABB Foundation Run for Research??

Lace up your sneakers for the annual AABB Foundation Run for Research. Whether you decide to run the 5k at a record-breaking pace or prefer a casual 1-mile walk, what’s important is your participation. Proceeds benefit the AABB Foundation, a nonprofit charitable organization that funds innovative scientific research and supports the careers of future leaders in transfusion medicine and biotherapies.?

Annual Meeting attendees can add the Run for Research during the Meeting registration process or add to their profile once registered. You do not need to attend the 2024 AABB Annual Meeting to join the fun! We encourage guests, families and local enthusiasts to register for the AABB Foundation Run for Research.?

Choose one of the Run for Research options:?

  • In-Person: The race will occur outdoors at the designated course near the George R. Brown Convention Center on Sunday, Oct. 20, at 7 a.m.?

  • Virtual: Complete your own 5K or 1-mile race anytime and anywhere between Oct. 19 and Oct. 22.?

  • Sleep-In: Hit the pillow instead of the pavement!?

AABB and AABB Foundation would like to thank this year’s sponsors – 雅培 , Fresenius Kabi and 强生公司 – for their support of the Run for Research.

Find out more and register now on the AABB website .


Reminder: AABB Seeking Feedback on Proposed CT Standards?

The proposed draft Standards for Cellular Therapy Services (CT Standards), 12th edition, is available for public comment through Oct. 8.?

A?summary memo ?that accompanies the proposed CT Standards provides a comprehensive description of the additions and edits in the draft.?

The Cellular Therapies Standards Committee encourages all interested individuals to submit comments. The standards in the 12th edition are in the proposed phase and 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.?

Visit the AABB website for more information or to submit comments .


AABB Introduces Discounted Bulk CABP Pricing for Organizations?

AABB is pleased to introduce a discounted bulk pricing option for organizations looking to certify multiple employees under AABB’s Certified Advanced Biotherapies Professional (CABP) Credentialing Program. This new offering allows institutions to receive a 15% discount on exam fees when registering four or more employees at the same time.?

AABB’s CABP credential – the first and only credential for biotherapies professionals – is a mark of distinction in the field, establishing minimum standards of competence and identifying qualified professionals. Candidates must meet specific prerequisites, pass a computer-based exam covering seven key domains and agree to a code of conduct to earn the certification for a three-year cycle.??

For more details on the CABP for yourself or your staff, including eligibility criteria, pricing, study tools and more, visit AABB’s CABP web page .?


AABB BIOTHERAPIES NEWSFEED: More Updates From the Field


AABB MEMBERS ZONE: Biotherapies Resources and Events?

September Issue of AABB News Focuses on Sickle Cell Disease

In recognition of National Sickle Cell Awareness Month, the September issue of AABB News focuses on sickle cell disease (SCD). This month’s first feature explores the operationalization of SCD gene therapies while the second highlights the treatment journey of Victoria Gray, a sickle cell warrior and the first patient to receive a CRISPR-based therapy for SCD.

This issue also explores the critical role of psychosocial support for sickle cell warriors and includes a conversation with Titilope Fasipe , MD, PhD, a pediatric hematologist-oncologist and co-director of the Sickle Cell and Thalassemia Program at Texas Children's Hospital Cancer and Hematology Center, who is also a patient with SCD. Finally, the “White Coats” interview features Akshay Sharma, MBBS, a clinician-scientist at St. Jude Children's Research Hospital , discussing efforts to expand global access to gene therapy treatments.

Non-members may access a?complimentary preview .?


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. Some recent highlights of a few of the subsections include:?

Asia Pacific Group (APG) Hatim Sidahmed PhD, DABRM, from M42 Health , presented Cord Blood Banking in Abu Dhabi, UAE .?

Cell Therapy Current & Emerging Topics (CT-CET) Avanish Mishra , PhD, from the Krantz Family Center for Cancer Research at Mass General Cancer Center and Harvard Medical School , presented Microfluidic Blood Cell Sorting Applied to the CAR T cell/NK T Cell Field.?

Cord Blood Subsection (CB) Several members attended Cord Blood Connect , an international meeting in which members of the cord blood and perinatal tissue community come together to discuss current information on scientific studies and clinical advances.?

Quality, Regulatory & Management (QRM) Olive Sturtevant MHP, MT(ASCP)SBB, SLS, CQA(ASQ), QRM team leader, addressed various FDA Guidance documents including Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Product and Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies .?

Spanish Language Subsection (SLS). The SLS is led by Maria De Los Angeles Muniz , MD; co-leader in transfusion medicine; JOSE A PEREZ-CARRILLO, MD. PhD. DBA. MHA , MD, PhD, MSc, specialist in clinical pathology and epidemiology and director of the blood bank of Clínica Colsanitas , Colombia; and Carlos Ferrari Rebolledo , laboratory head at VidaCel , Chile.??

The SLS discusses transfusion medicine and cell therapy to include topics of interest to all our members. AABB invites Spanish-speaking members of the blood and biotherapies community to become a member of AABB and continue to grow the SLS. Past presentations can be viewed by AABB members on the AABB subsection projects webpage . Recent discussion was on AABB Accreditation - Acreditación AABB - Bancos de Sangre y Servicios Transfusionales .?


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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.

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