Top News

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.

Catalent to Acquire Cook Pharmica for $950 Million

Sep 19, 2017

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

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

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.

Merck KGaA Opens New Life Sciences Center

Oct 16, 2017

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

FDA Expands Approval for J&J’s Psoriasis Biologic

Oct 16, 2017

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

Industry News

EMA Publishes Brexit Plan

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

Merck KGaA Opens New Life Sciences Center

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

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.

Supplier News

DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit

DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.

Temperature-Controlled Shipping Service Solution

Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.

Batavia Biosciences Expands Viral Vector Facilities

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

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

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.

GSK’s Shingles Vaccine Approved in Canada

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

SGS and Bavarian Nordic Form Vaccine Pact

The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.

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