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. 
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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

By Bruce Lehr, Delia Lyons

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

The Importance of Buffers in Downstream Processing

By Susan Haigney

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

By Peter Genest, John Joseph

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. 
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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.

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