ADVERTISEMENT
 |
|
Top Stories
Agilent Technologies Inc. announced that it signed a definitive agreement to acquire BioTek Instruments, a company that handles the design, manufacture, and distribution of innovative life science instrumentation for $1.165 billion.
/ read more /
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
/ read more /
|
|
|
SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
subscription offers
|
|
|
ADVERTISEMENT
 |
|
Industry News
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
/ read more /
FDA released draft guidance on using the USP pending monograph process in the drug application process.
/ read more /
More Industry News
|
|
|
|
Supplier News
The Applications Center of Excellence in Durham, NC, will offer development studies for JSR Life Sciences customers.
/ read more /
Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.
/ read more /
More Supplier News
|
|
|
|
Regulatory News
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
/ read more /
|
|
|
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
/ read more /
More Regulatory News
|
|
|
|
ADVERTISEMENT
The Bioprocessing Summit
convenes more than 1,500 international bioprocess professionals to share practical solutions for today's bioprocess challenges. Now in its eleventh year, the event has grown to include 16 distinct meetings with weeklong programming on upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. Along with conferences, the Summit also includes short courses and training seminars that provide in-depth coverage of critical bioprocess topics.
Learn more at  BioprocessingSummit.com »
|
|
|
|
FEATURED TOPICS |
|
UPSTREAM PROCESSING
Using a QbD approach from early-stage development through commercialization can ensure that upstream processes are efficient and reliable.
/ read more /
|
|
|
|
|
QUALITY SYSTEMS
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
/ read more /
|
|
|
|
|
MANUFACTURING
Recently released equipment and products include microbioreactor systems, cell therapy automation software, and IIoT-enabled flow sensors.
/ read more /
|
|
|
|
Events
September 3–4, 2019
September 16–18, 2019
September 18–19, 2019
more events
|
|
|
eBook
|
The editors examine the technology, practices, and regulatory approval questions facing
companies employing single-use technologies for commercial manufacturing.
|
|
|
|
|
