Top News

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

Oct 20, 2017

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

Oct 13, 2017

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

Pharma Gives Update on Puerto Rico Manufacturing Operations

Sep 28, 2017

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

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

Lilly and CureVac Partner on mRNA Cancer Vaccines in $2.73-Billion Deal

Oct 20, 2017

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

Oct 20, 2017

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform

Oct 16, 2017

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Industry News

Europe Takes Action to Foster Advanced Therapy Development

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

IBD Reveals 2017 Biotech Innovator Awards Winners

The financial news and research organization has announced the winners of the first Biotech Innovator Awards.

EMA Publishes Brexit Plan

The agency has published a continuity plan for its move from the United Kingdom.

Supplier News

Catapult, ANTRUK to Collaborate on Antimicrobial Research

The companies will embark on a joint antimicrobial research project, with the intent to discover antibiotic combinations that target resistance.

CiToxLAB Acquires Bioanalysis Facility in Montreal

The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.

SCHOTT Opens Facility in China

SCHOTT began production of glass ampoules, vials, and cartridges at a new facility at the SCHOTT Xinkang headquarters in Zhejiang, China.

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

Development of Purification for Challenging Fc-Fusion Proteins

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

Harvest of Human Mesenchymal Stem Cells from Microcarriers

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Bioburden Control in the Biopharmaceutical Industry

Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.

Standards/Regulations

REMS Guidance Published

FDA published guidance on the format and content of REMS documents.

FDA Releases Guidance on Resolving Issues with the Agency

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

FDA Publishes Antiviral Guidance

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

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

Optimizing Protein Aggregate Analysis by SEC

A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.

Control Viral Contaminants with Effective Testing

Detecting viral contaminants in biologic-based medicines—and identifying their source—requires a holistic testing approach.

Accelerating Genetic Medicine R&D Using Microfluidics

This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.

Formulation

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.

Ajinomoto Althea Adds High Potency Capabilities

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Accelerating Genetic Medicine R&D Using Microfluidics

This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.

Single-Use Systems

Singular Developments Advance TFF Technology

Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.

Process Chromatography: Continuous Optimization

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

Larger Peristaltic Pumps Allow Scale-Up for Biopharm Projects

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

mAb Development

NJII and Rutgers University to Form the New Jersey Continuous Manufacturing Institute

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

ProBioGen and Chiome in Antibody Manufacturing Deal

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

BARDA Funds Ebola Vaccine and Drug Development

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.

Vaccine Development

Lilly and CureVac Partner on mRNA Cancer Vaccines in $2.73-Billion Deal

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

DCPrime and Apceth Biopharma Collaborate on Cancer Vaccines

The two companies announced their collaboration for the production and development of cancer vaccines.

Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

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