Top News

Charles River Laboratories Acquires MPI Research

Feb 13, 2018

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

Trump Blasts Drug Prices, Sidesteps Health Reform

Feb 01, 2018

The President described US drug costs as unfair and stated that prices will come down.

Sanofi to Acquire Ablynx in $4.8-Billion Deal

Jan 30, 2018

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

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

AbbVie, Voyager Partner for New Alzheimer's Therapies

Feb 21, 2018

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

GSK's Influenza Vaccine Gets EU Nod for Expanded Indication

Feb 15, 2018

Fluarix Tetra has been approved for use in children aged six months and above.

Ferring to Invest in New Biotech Center

Feb 14, 2018

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Industry News

Hospira Recalls Labetalol Hydrochloride Due to Cracked Vials

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

Smithfield Bioscience, University of Virginia Partner for Regenerative Medicine Research

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

Jefferson and NIBRT Partner on New Biomanufacturing Training Center

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Supplier News

Samsung BioLogics Gets $148-Million Contract for New Manufacturing Plant

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

Smithfield Bioscience, University of Virginia Partner for Regenerative Medicine Research

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

Avid Bioservices to Commercially Manufacture Enzyme Replacement Therapy

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

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

ADC Bio to Develop New Bioconjugation Process

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Industry Adoption of Single-Use Systems Remains Low

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

Acquity Arc Bio System Improves Bioseparation Analytical Methods

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

Standards/Regulations

FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

FDA Uses New Pilot Plan for the Development of Guidance on Neurological Treatments

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

FDA Gets Boost from New Budget Plan

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

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

AbbVie, Voyager Partner for New Alzheimer's Therapies

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

Cobra Biologics, Symbiosis Awarded Innovate UK Grant

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

FDA Framework Spurs Advanced Therapies

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

Analytics

Charles River Laboratories Acquires MPI Research

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

Navigating Data Integrity in the Modern Lab

Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.

Maintaining Lab Data Integrity

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.

Formulation

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.

Survey Measures Biopharma Career Highs and Lows

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Single-Use Systems

Jefferson and NIBRT Partner on New Biomanufacturing Training Center

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

ABEC Expands Single-Use Manufacturing Capability

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

Disposal Options for Single-Use Systems

BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.

mAb Development

Ferring to Invest in New Biotech Center

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Industry Adoption of Single-Use Systems Remains Low

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

Acquity Arc Bio System Improves Bioseparation Analytical Methods

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

Vaccine Development

GSK's Influenza Vaccine Gets EU Nod for Expanded Indication

Fluarix Tetra has been approved for use in children aged six months and above.

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.

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