Top News

Removing Troublesome Solubilizing Excipients from Injectables

May 19, 2016

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

NIH to Launch Large-Scale HIV Vaccine Trial

May 18, 2016

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen

Pfizer to Acquire Anacor

May 16, 2016

Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.

Biopharma News

Sanofi Makes Changes to Executive Committee

May 23, 2016

Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.

Celgene and Agios Collaborate on Metabolic Immuno-Oncology

May 19, 2016

Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.

FDA Approves Atezolizumab

May 19, 2016

Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.

Industry News

NIH to Launch Large-Scale HIV Vaccine Trial

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen

EMA Publishes Annual Report

The agency detailed its 2015 achievements in an annual report.

Well Care Compounding Pharmacy Issues Recall

The company recalls products due to sterility concerns.

Supplier News

Althea Patents Method to Crystallize Proteins

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

AAPS Announces 2016 Award Winners

The awards were presented at the AAPS Biotechnology Conference and included awards for ligand binding, innovation in biotechnology, and graduate student symposiums.

Pelican BioThermal Enters Into Partnerships in South America

The company has partnered with NatBio and BioThermal Solutions to offer cold chain logistics support in South America.

Upstream Processing

Applications of Microfluidics in Bioprocessing

Microchannels show potential benefits for inertial cell sorting and for introducing genetic material into cells.

Platform Approach Speeds Process Development

A modular cell-culture platform demonstrates accelerated process development.

Continuous Processing for the Production of Biopharmaceuticals

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

Downstream Processing

MilliporeSigma Expands California GMP Facility

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

The Importance of Buffers in Downstream Processing

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Continuous Processing for the Production of Biopharmaceuticals

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

Formulation

Removing Troublesome Solubilizing Excipients from Injectables

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Althea Patents Method to Crystallize Proteins

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Lessons Learned Accelerate Vaccine Development

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

CPhI Biopharma News

Market Opportunities to be Explored at CPhI Japan

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

Ompi Presents Alternative Sterilization Method for Biologics

The process provides an alternative to the sterilization of cartridges and vials with ethylene oxide (EtO).

Peer-Review Research

A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Size-Exclusion Chromatography for Preparative Purification of Biomolecules

The authors provide application data to support the use of SEC beyond small-scale operations.

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Standards/Regulations

EMA Publishes Annual Report

The agency detailed its 2015 achievements in an annual report.

FDA Issues Biomarker Qualification Guidance

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

FDA Warns of Serious Side Effects Associated with Fluoroquinolone Drugs

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Analytics

An Integrated Approach to Ensure the Viral Safety of Biotherapeutics

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

FDA Releases Data Integrity Guidance

The agency published guidance on data integrity as it is relates to CGMP compliance.

Single-Use Systems

MilliporeSigma Expands California GMP Facility

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Qualification and Validation of Single-Use Shipping Systems

The authors provide their perspectives on shipping validation.

GE Healthcare Delivers Modular Biopharma Facility to China

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

mAb Development

Seattle Genetics Presents New Antibody-Drug Conjugate Data at AACR

Linker technology and drug combinations play an important role in the efficacy of ADCs.

Using Site-Specific Conjugation for Homogenous Bioconjugates

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

Continuous Processing for the Production of Biopharmaceuticals

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

Vaccine Development

MilliporeSigma Expands California GMP Facility

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

NIH Study Identifies Better Parameter to Predict Flu Vaccine Effectiveness

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.

Anti-Vaccine Movement Rears Its Ugly Head Again

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

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