Top News

Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B

Oct 10, 2018

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

Novartis to Sell Parts of Sandoz in $1-Billion Deal

Sep 06, 2018

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

BioPharm eBooks

Single-Use Systems 2018 eBook
A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs. 

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Biopharma News

Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Roche Acquires Tusk Therapeutics

Oct 11, 2018

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

GSK, Hitachi Chemical in T-Cell Manufacturing Pact

Oct 10, 2018

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

Industry News

FDA Publishes Guidance on the Rare Disease Treatments

The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

FDA Takes Steps to Modernize Drug Development

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

FDA Releases Guidance on Targeted Therapies

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

Supplier News

MilliporeSigma Wins CPhI Pharma Award for Excellence in Innovation

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

MilliporeSigma Offers Insect Platform for Viral Vaccines and Gene Therapy Development

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

Almac Invests in Next-Generation Sequencing Capabilities

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

Upstream Processing

A Plastic Pipeline for Commercial Bioprocessing?

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

APC and Bavarian Nordic Build 500-L Single-Use Biologics Pilot Plant

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Roquette Showcases Biopharma Innovations at CPhI Worldwide 2018

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Downstream Processing

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

A Plastic Pipeline for Commercial Bioprocessing?

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

APC and Bavarian Nordic Build 500-L Single-Use Biologics Pilot Plant

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Standards/Regulations

USP Proposes a New Chapter for Rapid Sterility Testing

The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

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

MilliporeSigma Offers Insect Platform for Viral Vaccines and Gene Therapy Development

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

GSK, Hitachi Chemical in T-Cell Manufacturing Pact

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

Analytics

Almac Invests in Next-Generation Sequencing Capabilities

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

Reaction Biology and Promega Partner on Bioassay Tool

The companies collaborated to launch a new cell-based profiling service for biochemical assay.

Formulation

Outsourcing Development: Small-Scale to Commercial

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

Nanoform Invests in Nanoparticle Technology for Drug Development

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Thermo Fisher Scientific to Acquire Advanced Bioprocessing Business from BD

Becton Dickinson’s (BD) Advanced Bioprocessing business will be integrated into Thermo Fisher's Life Sciences Solutions segment.

Single-Use Systems

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

A Plastic Pipeline for Commercial Bioprocessing?

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

APC and Bavarian Nordic Build 500-L Single-Use Biologics Pilot Plant

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

mAb Development

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

Assessing Viral Inactivation for Continuous Processing

Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.

Improving Aggregate Removal to Enhance Clinical Manufacturing of MAbs

Hydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process to remove monoclonal antibody aggregates while maintaining purity at ≥99% than a mixed-mode bind/elute procedure.

Vaccine Development

MilliporeSigma Offers Insect Platform for Viral Vaccines and Gene Therapy Development

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

Scientists Develop New Vaccine for Lassa Fever and Rabies

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

New Analytical Instrument Could Change Vaccine Development Through Faster Viral Detection

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

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