Top News
Merck KGaA to Sell Consumer Health Biz to Procter & Gamble for $4.2 Billion
Apr 19, 2018
The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.
Sanofi to Divest European Generics Business in Deal Worth $2.4 Billion
Apr 19, 2018
Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.
Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility
Apr 12, 2018
The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.
BioPharm eBooks
Outsourcing Resources 2018 eBook
An annual review of the market for outsourced contract services, regulatory topics, manufacturing, development, and supply chain issues.
View ebook
Biopharma News
LNC Therapeutics Appoints New CEO and Advances Microbiome-Based Drug R&D
Apr 20, 2018
LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.
J&J, BMS Team Up on Cardiovascular Therapies
Apr 19, 2018
Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.
FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug
Apr 19, 2018
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
Industry News
CDER Publishes Drug Safety Report
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
FDA Seeks to Advance Treatments for Opioid Use Disorder
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
FDA Publishes Q&A on GMPs for APIs
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Supplier News
Sanofi Buys Berkeley Lights’ Cell Line Platform
The new platform is expected to speed up cell line development.
MilliporeSigma Launches New Single-Use Technologies at INTERPHEX 2018 and Wins Best Tech Award
The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.
WuXi AppTec Expands Drug Development Testing Services
The expanded Laboratory Testing Division, located in Cranbury, NJ, will expand the company’s testing services in the United States.
Trends in Bioprocessing
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
The Importance of Buffers in Downstream Processing
Industry experts provide insights on the challenges and importance of using buffers in downstream processing.
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a biopharmaceutical facility design.
Upstream Processing
Sanofi Buys Berkeley Lights’ Cell Line Platform
The new platform is expected to speed up cell line development.
INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.
Ambr 250 High Throughput Bioreactor System Speeds Up Intensified Cell Culture Process Development
Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.
Downstream Processing
INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
Employing Spectroscopic Tools in Downstream Process Control
Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.
Standards/Regulations
CDER Publishes Drug Safety Report
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
FDA Seeks to Advance Treatments for Opioid Use Disorder
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
FDA Publishes Q&A on GMPs for APIs
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Sponsored Videos
Sponsored eBooks
QbD and PAT in Biopharmaceutical Development
In this eBook, learn how the adoption of QbD and Process Analytical Technology (PAT) as well as Design of Experiments techniques help biopharmaceutical companies improve efficiency and accelerate time to market.
More eBooks
Cell and Gene Therapies
GE Speeds Up Production of Viral Vector-Based Therapeutics
The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.
Sartorius Stedim Biotech and Penn State University Announce Biotechnology Partnership
Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.
Lonza Opens Dedicated Cell and Gene Therapy Manufacturing Facility
The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.
Analytics
Publication Brings Analytical Science to Cannabis Industry
A new scientific publication examines analytical processes for the emerging legal cannabis industry.
Multiple Views Deliver Protein Particle Characterization
Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.
New Immunoassay Technology Improves Workflow
Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.
Formulation
Multiple Views Deliver Protein Particle Characterization
Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.
V ClinBio Acquires Cellix to Gain Patented Drug Delivery Technology
The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.
Stability Testing Ensures Proper Packaging for Drug Storage
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
Single-Use Systems
MilliporeSigma Launches New Single-Use Technologies at INTERPHEX 2018 and Wins Best Tech Award
The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.
GE Speeds Up Production of Viral Vector-Based Therapeutics
The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.
INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.
mAb Development
GE Speeds Up Production of Viral Vector-Based Therapeutics
The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.
Amgen to Build Next-Generation Biomanufacturing Plant
The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.
Wuxi Biologics to Install Large-Scale Single-Use Bioreactor
The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.
Vaccine Development
Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility
The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
GlobalData Reports Need to Shift to Newer Vaccine Manufacturing Technologies
GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.
|
|---|
|
Outsourcing
Catalent Adds Clinical Supplies Capacity
A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.
Cost Cutting to Drive 12% Growth in CRO Outsourcing Through 2021, New Study Finds
A new study by the Business Research Company reveals prominent contract research organization outsourcing trends.
New Jersey Firm Gets FDA Warning Letter
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Current Issue
Wearable Injection Devices Address Delivery Challenges
Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.
When One Therapy No Longer Fits All
More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.
Outsourcing Analytical Processes in Biologics Development
Outsourcing analytics can be a cost-effective way for biopharma companies to adapt to new technologies and regulations.
Single-Use Systems Advance Upstream Processing
Developments and investments in single-use systems advance upstream biomanufacturing.
Webcasts
CPhI Biopharma News
Serialization Expert Rick Seibert Presents at CPhI North America 2018
Serialization technology and implementation expert Rick Seibert will present an insight briefing on recent serialization challenges at CPhI North America in Philadelphia, PA.
Insight Briefing on Patents and Exclusivity at CPhI North America 2018
David Weingarten, PhD, and Mark Feldstein, PhD, will present ways to optimize pharma patent protection to avoid generic competition and increase return on investment at CPhI North America 2018.
Sponsored Links
