Top News

IMS Health Holdings and Quintiles to Combine

May 03, 2016

The companies have agreed to an all-stock merger of equals transaction anticipated to close in the second half of 2016.

AbbVie to Acquire Stemcentrx

Apr 28, 2016

AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.

NIH Suspends Research in Sterile Production Facilities

Apr 20, 2016

NIH decided to suspend research after the facilities were found not in compliance with CGMP practices.

Biopharma News

WAVE and Pfizer to Collaborate on the Development of Nucleic Acid Therapies

May 05, 2016

Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.

MilliporeSigma Expands California GMP Facility

May 04, 2016

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

Sanofi Collaborates with Duke University and Massachusetts General Hospital

May 03, 2016

The collaborations have the goal of creating new tools that will help predict how people with Type 2 diabetes adhere to their medication.

Industry News

Report Shows Increase in Capacity in Cell and Gene Therapy Manufacturing in the UK

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

CPhI China Returns to the Shanghai New International Exhibition Center

CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.

EMA Approves Gazyvaro for Treatment of White Blood Cell Cancer

The agency extends the indication of the drug in combination with bendamustine.

Supplier News

Entegris Introduces Gamma-Stable Single-Use Bags

The company’s Aramus bags are made of an innovative material that is unlike that of the material currently used in commercial single-use bags.

IMS Health Holdings and Quintiles to Combine

The companies have agreed to an all-stock merger of equals transaction anticipated to close in the second half of 2016.

MilliporeSigma Introduces Multi-Use Disposable Sterile Connectors at INTERPHEX

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

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

Lessons Learned Accelerate Vaccine Development

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

US Regulators Permit Kannalife Sciences to Import Cannabidiol for Feasibility Studies

The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

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

Federal Judge Enters Order of Permanent Injunction Against Compounding Pharmacy Owner

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

Reporting Quality Metrics to FDA

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

EMA Approves Gazyvaro for Treatment of White Blood Cell Cancer

The agency extends the indication of the drug in combination with bendamustine.

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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