Top News

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.

DHSC Directs Pharma to Stockpile Medicines

Aug 23, 2018

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

UK Outlines Potential Pharma Changes Post-Brexit

Aug 23, 2018

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

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

EMA Recommends New Gene Therapy for Rare Inherited Disorder for Approval

Sep 21, 2018

The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.

Regeneron Invest in Facilities and Manufacturing Expansion

Sep 20, 2018

The biopharmaceutical company will invest approximately $800 million to expand facilities and manufacturing capacity at its campus in Rensselaer County, NY.

BeiGene Selects GE Healthcare’s Biologics Factory to Boost its Manufacturing Capacity

Sep 20, 2018

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Industry News

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.

NIBRT Scientist Leads Program for Single-Cell Analysis Research

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Experts Suggest Trade and Patent Changes Could Increase Healthcare Cost by $100 Billion

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

Supplier News

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.

Alcami to Discuss Serialization at CPhI Worldwide

The company will be presenting at CPhI Worldwide on Oct. 11, 2018.

Avista Pharma Solutions Expands Service Offerings in New England

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

Upstream Processing

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.

MilliporeSigma Adds CEX Resin and Amino Acids

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

Elements in Raw Materials May Impact Product Quality

Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.

Downstream Processing

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.

MilliporeSigma Adds CEX Resin and Amino Acids

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

Chromatography Resin Designed to Boost Process-Scale Productivity

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.

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

Lonza Expands Product Lifecycle Management Capabilities

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

Key Biologics and Astarte Biologics Merge

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Analytics

Stream Bio, 2BScientific Launch New Bioimaging Probes

The companies have partnered to launch Conjugated Polymer Nanoparticle (CPN) products for use in molecular imaging and R&D applications.

FDA Expands NDMA Investigation to All ARB Class Drugs

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Be a Part of the Solution

Sharing of bioprocessing know-how can help resolve pressing industry problems.

Formulation

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.

QbD in the Development of ADCs with PBD Dimer Warheads

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.

Single-Use Systems

BeiGene Selects GE Healthcare’s Biologics Factory to Boost its Manufacturing Capacity

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Lonza Expands Product Lifecycle Management Capabilities

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

Pall and Aetos Biologics Partner on Biosimilar Manufacturing

The collaboration will focus on developing manufacturing solutions for biosimilars.

mAb Development

BeiGene Selects GE Healthcare’s Biologics Factory to Boost its Manufacturing Capacity

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Evaluating the Rewards vs. the Risks of Automation

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

Maintaining Cell Line Integrity

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

Vaccine Development

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.

Study Finds Candidate for Universal Flu Vaccine Protects Against Multiple Strains

Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.

CEPI, IDT Partner to Develop MERS Vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

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