NIIMBL Publishes 2018-19 Annual Report
NIIMBL is pleased to publish its 2018-19 Annual Report. The Annual Report details the Institute’s initiatives, activities, and projects through February 28, 2019.
NIIMBL Welcomes Dr. John Erickson as Senior Fellow
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce Dr. John Erickson has joined the Institute as NIIMBL Senior Fellow, effective June 3, 2019. Dr. Erickson joins NIIMBL after nearly 30 years at GlaxoSmithKline (GSK), where he held a variety of roles in process development, project management, and manufacturing.
COURSE ANNOUNCEMENT: Essentials of Automation for Biomanufacturing
An output of a NIIMBL-funded project, we are excited to announce a new blended course for members of the NIIMBL community seeking to up-skill or re-skill their personnel on automation technologies as used in the context of biomanufacturing. The course is recommended for personnel who work in multi-disciplinary teams with automation experts since this blended course will give the vocabulary, concepts, knowledge, and skills to work effectively within such teams. The course materials align with an automation competency framework for the Life Sciences and the materials have been vetted by senior automation professionals within Genentech and Merck. NIIMBL members receive a discount on both the online and hands-on courses.
Biomanufacturing Education and Workforce Development: Time for a Systems Change!
Emerging technologies such as gene therapy and precision medicine have caused industry to begin thinking about their future workforce development and training needs.
In an article published on Linkedin this week, NIIMBL’s Workforce Director John Balchunas explores some guiding principles and “themes for action” as the biopharmaceutical industry works define the skills needed to manufacture these new types of therapies.
NIST/FDA Workshop: Standards for NGS Detection of Viral Adventitious Agents
Mark your calendars for a two-day NIST/FDA workshop titled Standards for NGS Detection of Viral Adventitious Agents in Biologics and Biomanufacturing on September 18-19, 2019 on the NIST campus in Gaithersburg, MD. The workshop will explore current standards and reference materials for next-generation sequencing and what additional types of standards that are needed. Additional details will be provided soon.
Global Health Fund Workshop on Alternatives to Animal-based Release Testing
NEWARK, Del., April 2, 2019 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will host a Global Health Fund Workshop titled Replacing Animal-based Release Testing for Vaccines on Thursday, April 18, 2019 in Arlington, VA. The workshop is open to NIIMBL members, non-members and federal scientists with knowledge of in vitro vaccine potency and toxicity tests.
Nondestructive Analytics for Biologics and Continuous Biomanufacturing Lecture
Last month, Dr. Bruce Yu, Professor of Pharmaceutical Sciences and Director of the Bio- and Nano-Technology Center at the University of Maryland School of Pharmacy, gave a lecture on water proton NMR as a nondestructive, contract-free method of analyzing the quality of biologic products as part of the FDA CERSI lecture series. You can access a recording of the lecture at https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm631405.htm.
Thank You to the NIIMBL Community as We Celebrate Our Second Anniversary
A little over two years ago, NIIMBL began with a vision to accelerate biopharmaceutical manufacturing innovation in the United States. Stakeholders from all areas of the biopharmaceutical community have come together to put that vision into motion. The community has focused on the technologies and training programs that will not only strengthen our economy but also contribute to improved health outcomes for all patients.
Vision Workshop Kicks Off Next Roadmapping Cycle
NIIMBL began the next cycle of its biopharmaceutical roadmapping initiative on January 23 when it hosted a Vision Workshop at North Carolina State University. The Vision Workshop, facilitated by the BioPhorum Operations Group, brought together representatives from industry and academia to discuss potential roadmapping topics for 2019.
NIIMBL Welcomes MedImmune, Pfizer and Sartorius to its Member Community
NEWARK, Del., January 31, 2019 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce MedImmune, a member of the AstraZeneca Group, Pfizer Inc., and Sartorius have joined the Institute as members.
Communication and Flexibility Among Key Factors for Successful Collaborations
A recent article published in Nature describes the challenges industry and academic institutions encounter in their collaboration efforts and provides useful advice on mitigating those challenges.
NIIMBL Launches Global Health Fund
NEWARK, Del., January 10, 2019 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce a grant to help fund the advancement of biopharmaceutical manufacturing technology in the U.S. and globally from the Bill & Melinda Gates Foundation.