Top News

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Nov 21, 2017

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

FDA to Recognize Inspections from EU Drug Authorities

Oct 31, 2017

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

UBM Announces BioLive Event

Oct 26, 2017

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

BioPharm eBooks

Development Strategies for Emerging Therapies
Review the state of emerging therapies, roadblocks to development, patent implications, stem cell harvesting, purification of viral vectors, automation of cell-therapy manufacturing, vaccine delivery innovations, and research tools.    
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Biopharma News

FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug

Nov 20, 2017

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

Nov 20, 2017

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

Boehringer Ingelheim Launches Open-Access Platform of Selected Preclinical Molecules

Nov 20, 2017

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

Industry News

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

Novartis, ASCP, and ACS Partner for African Cancer Initiative

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

CPhI Global Pharma Index Shows India’s Reputation Improving

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

Supplier News

Design Solution for Single-Use Technology Applications

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

Integrated Analytical Software Solutions for Clinical and Regulatory Processes

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

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

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.

Sartorius Stedim Cellca Builds Laboratory and Office Facility in Germany

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Molecular Cloning, Expression, and Purification of a Recombinant Fusion Protein (rNT-gp96-NT300)

This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

Downstream Processing

Connector Integrity in Single-Use Biomanufacturing Systems

Connectors are a critical element in the process optimization of single-use bioprocessing systems.

Connectors and Sealing Mechanisms—and Their Impact on Process Protection

The use of external retainers to enhance the seal between connectors and tubing is an essential component in single-use manufacturing systems.

Development of Purification for Challenging Fc-Fusion Proteins

This study outlines methods for an alternative protein-polishing process for challenging proteins.

Standards/Regulations

FDA’s Policy on Regenerative Medicine Therapies

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

EMA Recommends Ten Drugs for Approval

Two of the medicines recommended for approval are orphan drugs.

FDA Works to Get Pharma Up and Running in Puerto Rico

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

Videos

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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Analytics

Awards Recognize Bio/Pharma Industry Contributions

CPhI Pharma Awards honor companies and individuals driving the pharma industry forward.

Development of a Technique for Quantifying Protein Degradation

This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.

Process Characterization Essentials, Model Optimization, and Controlling the Process

This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.

Formulation

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

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

ADC Targets Fail Because of Aggregation Problems

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Formulation of Biologics for Non-Invasive Delivery

There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.

Single-Use Systems

Design Solution for Single-Use Technology Applications

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

Connector Integrity in Single-Use Biomanufacturing Systems

Connectors are a critical element in the process optimization of single-use bioprocessing systems.

mAb Development

FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Vaccine Development

Dynavax Wins FDA Approval for Hep B Vaccine

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

Human Vaccines Project Creates Research Program to Develop Universal Influenza Vaccines

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

FDA Approves GSK’s Shingles Vaccine

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

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