Top News

Novartis Acquires AveXis for $8.7 Billion

May 16, 2018

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

Lilly to Acquire ARMO BioSciences for $1.6 Billion

May 15, 2018

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

May 14, 2018

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

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

FDA Approves First Preventive Treatment for Migraine

May 21, 2018

The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.

Catalent to Develop Biosimilars for Valerius Biopharma

May 16, 2018

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Novartis Acquires AveXis for $8.7 Billion

May 16, 2018

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

Industry News

FDA Commissioner Puts Branded Companies on Notice

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

European and Indian Pharmacopoeias Coordinate on Quality Standards

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

IPEC-Americas Acquires Global Excipient Event

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Supplier News

Parker Bioscience Expands UK Facilities

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

Catalent to Develop Biosimilars for Valerius Biopharma

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

GE Increases Cell Culture Media Production Capacity

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

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

Managing Uncertainty in Continuous Biomanufacturing

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Leveraging Data for Better Biopharmaceutical Process Control

The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and downstream applications.

Sanofi Buys Berkeley Lights’ Cell Line Platform

The new platform is expected to speed up cell line development.

Downstream Processing

Putting Viral Clearance Capabilities to the Test

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

Managing Uncertainty in Continuous Biomanufacturing

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

Standards/Regulations

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

Understanding Validation and Technical Transfer, Part 2

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to biopharmaceutical processes and systems.

Sponsored Videos

Sponsored eBooks

QbD and PAT in Biopharmaceutical Development
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Cell and Gene Therapies

Lonza to Invest in Mid-Scale Biologics, Cell Therapy Manufacturing

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

New Processing System Streamlines Cell Therapy Manufacturing

GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.

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.

Analytics

Wyatt Technology Announces Executive Team Changes

Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.

Putting Viral Clearance Capabilities to the Test

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

Formulation

Wearable Injection Devices Address Delivery Challenges

Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.

Multiple Views Deliver Protein Particle Characterization

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Sensor Technology Aims to Improve Medication Adherence

Sensors and devices being developed by nGageIT Digital Health Solutions can track patient use of oral solid-dosage or injectable drugs.

Single-Use Systems

Parker Bioscience Expands UK Facilities

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

WuXi Biologics to Invest $389 Million in New Biomanufacturing Facility

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

Managing Uncertainty in Continuous Biomanufacturing

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

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

Merck, Moderna Expand mRNA Cancer Vaccines Partnership

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.

Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

EMA Updates Flu Vaccine Recommendations

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

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