Top News

Hospitals Launch Their Own Generic Drug Company

Jan 19, 2018

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

FDA Commissioner Gottlieb Gives Update on Saline and Amino Acid Shortages

Jan 05, 2018

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

Tax Overhaul a Plus for Pharma

Dec 20, 2017

New tax legislation may result in savings for biopharma companies.

BioPharm eBooks

Vaccines Development and Manufacturing 2017 eBook
Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.      
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Biopharma News

Automated Collector for Analytical Chromatography Applications

Jan 18, 2018

The NGC Fraction Collector from Bio-Rad Laboratories allows researchers to choose how to collect and when to access their fractions for analytical or preparative chromatography applications.

Takeda to Acquire TiGenix

Jan 12, 2018

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

Athenex Hires German Engineering Firm to Build Manufacturing Facility

Jan 11, 2018

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

Industry News

Hospitals Launch Their Own Generic Drug Company

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

Experts Partner to Optimize Lyophilization

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

Baxter Extends Recall of Nexterone

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

Supplier News

GE Healthcare to Equip Cell Therapy Manufacturing Facility with Single-Use Platform

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

New Dividable Cryotube Allows for Multiple Sample Storage in Single Tube

1CryoBio’s Flexiquot technology allows for the deep-freeze storage and handling of multiple aliquots in a single tube, winning it the CPhI Pharma Award 2017 for Excellence in Pharma: Analysis, Testing, and Quality Control.

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

Expansions in Cell Culture Facility Offerings

Recent investments show expansion activity in cell culture facilities.

BioTek Adds “OnDemand” Mode to BioSpa Software

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Groninger and Martin Christ Partner at CPhI Worldwide 2017

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

Downstream Processing

Using Direct Transition Analysis in Chromatography

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

Evolving UF/DF Capabilities

Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.

Reducing Cross-Contamination Risks in Process Chromatography

Single-use systems provide replaceable fluid paths.

Standards/Regulations

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Will Pharma Meet the Drug Tracking Deadline?

Manufacturers and trading partners struggle to meet drug tracking requirements

FDA’s Policy on Regenerative Medicine Therapies

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Sponsored Videos

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Analytics

Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

Automated Control Concepts Launches New Bioreactor Control System for Data Collection and Analysis

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.

Using Direct Transition Analysis in Chromatography

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

Formulation

Stability Testing Ensures Proper Packaging for Drug Storage

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

Survey Measures Biopharma Career Highs and Lows

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

Single-Use Systems

GE Healthcare to Equip Cell Therapy Manufacturing Facility with Single-Use Platform

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Sartorius Stedim Biotech to Equip Abzena Single-Use Manufacturing Sites

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

Single-Use Filling Assemblies for Aseptic Fill/Finish Applications

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

mAb Development

MAbs Against Zika Show Promise

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

New Approach for the CAR-T Cell Therapy Treatment of Cancer

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

Sartorius Stedim Biotech to Equip Abzena Single-Use Manufacturing Sites

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

Vaccine Development

MAbs Against Zika Show Promise

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

GeoVax and Vaxeal to Collaborate on Cancer Immunotherapy Program

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

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