Top News

Clinical Development Success Rates Examined in New BIO Report

May 25, 2016

In the largest-ever report of its kind, drugs entering clinical development in Phase I were found to have only a 1 in 10 chance of FDA approval.

EMA Accepts Sandoz’s Regulatory Filing for Biosimilar Rituximab

May 25, 2016

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

FDA Accepts Samsung Bioepis' BLA for Remicade Biosimilar

May 24, 2016

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

Biopharma News

Jazz Pharmaceuticals Acquires Celator

May 31, 2016

Jazz will acquire Celator for approximately $1.5 billion.

EU Grants Approval to Remicade Biosimilar Flixabi

May 31, 2016

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

FDA Accepts Samsung Bioepis' BLA for Remicade Biosimilar

May 24, 2016

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

Industry News

FDA Issues Warning Letter to API Manufacturer

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

USGS Study Indicates Pharmaceuticals are Widespread in Small Streams in the Southeast US

The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.

AAPS Grants Five Graduate Student Fellowships

The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.

Supplier News

Evercyte and VTU Launch Recombinant Media Supplement

The companies have launched VEGF 165, their first joint product for cell culture applications.

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.

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 Accepts Sandoz’s Regulatory Filing for Biosimilar Rituximab

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

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.

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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