TOP STORIES
WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.
/ read more /
Ongoing coronavirus outbreak prompts date change to ensure safety of trade show participants.
/ read more /
|
|
|
SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
subscription offers
|
|
| |
|
Industry News
At the event, Centogene will also announce its plans to host the annual International Rare Disease Film Festival in Berlin in 2021.
/ read more /
FDA will observe Rare Disease Day on Feb. 29, 2020, with events surrounding the day’s 2020 theme, “Reframe Rare for Rare Disease Day.”
/ read more /
MORE INDUSTRY NEWS
|
| |
|
Biopharma News
The companies aim to develop novel cell therapies for treating multiple cancers.
/ read more /
FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab).
/ read more /
More Biopharma News
|
|
| |
|
Supplier News
Aprecia, which has an FDA-approved 3D-printed medication, will collaborate with Purdue’s College of Pharmacy to accelerate development in 3DP pharmaceuticals.
/ read more /
|
|
The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.
/ read more /
More Supplier News
|
|
Regulatory News
US and European regulatory officials continue to anticipate supply shortages in multiple areas.
/ read more /
|
FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.
/ read more /
More Regulatory News
|
|
FEATURED TOPICS |
|
ANALYTICAL METHODS
Analytical solutions are improving for raw material testing, process development, drug product release, and more.
/ read more /
|
|
|
|
|
QUALITY
CH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
/ read more /
|
|
|
|
|
DOWNSTREAM PROCESSING
Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.
/ read more /
|
|
|
|
MANUFACTURING
To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.
/ read more /
|
|
|
TAKE THE SURVEY
Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
/ Take the survey /
|
| |
Events
March 10–11, 2020
March 18–19, 2020
March 24–26, 2020
more events
|
|
|
eBook
|
In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.
|
|
|
|
| |
