ISPE

OCTOBER 26, 2022

Reintroducing the liaison role of International Board members with individual Chapters and Affiliates has given us direct lines of communication to the mutual benefit of the International Board and the local groups. It has been a great honor for me to serve as Chair and certainly a highlight in my professional career.

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ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Viral antigen vaccines. For example: Live vaccine manufacturing. Complete Data Gathering.

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Vaccines Compounding Documentation FDA 97

ISPE

MAY 9, 2023

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

Pharmaceutical Technology

JUNE 6, 2023

With two historic FDA approvals for RSV vaccines in the last two months, this issue’s lead interview addresses the pertinent question of access— how to ensure eligible individuals across the world get this vaccine. Please check your email to download the Report.

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Vaccines FDA Communication 52

ISPE

AUGUST 29, 2022

Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies. Regulatory. Unlock Access to Member-Only Content.

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Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. You may unsubscribe from these ISPE communications at any time.

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Documentation FDA Packaging Communication 52

ISPE

JANUARY 10, 2023

Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. You may unsubscribe from these ISPE communications at any time. Leave this field blank

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Packaging FDA Communication Vaccines 52

ISPE

OCTOBER 27, 2022

AAV vectors are commonly associated with in-vivo gene therapies; AdV vectors show promise for vaccine applications including oncolytic virotherapy; and LV vectors are commonly associated with such ex-vivo approaches as CAR-T cell therapy. You may unsubscribe from these ISPE communications at any time. Accessed 11 August 2022.

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Packaging Communication Immunization Vaccines 52