Top News

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.

NIH Study Identifies Better Parameter to Predict Flu Vaccine Effectiveness

Apr 20, 2016

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

Biopharma News

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.

WHO Campaigns to Close Immunization Gap

Apr 28, 2016

MSD joined the WHO campaign in Africa, which is focused on staying polio free.

US National Science and Technology Council Promotes Advanced Manufacturing

Apr 25, 2016

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

Industry News

EMA Collaborates with Physicians

The agency holds a workshop to strengthen collaboration with healthcare providers.

Fresenius Kabi Recalls Sensorcaine-MPF Injection, USP

The company voluntarily recalls product due to particulate matter.

WHO Releases Report on Eliminating Malaria

WHO report highlights goal of eliminating malaria in 35 countries by 2030.

Supplier News

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.

Plasticell Receives Queen’s Award for Enterprise in Innovation 2016

Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research.

Walker Barrier Systems Products to be Rebranded as Extract Technology

Extract Technology’s portfolio will now include aseptic solutions, containment solutions, restricted access barriers, and mobile cleanrooms for the pharmaceutical, healthcare, biotech and chemical markets.

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

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.

Achieving Cost-Effective Bioprocesses

Experts in the field share some best practices for optimizing process economics in biomanufacturing.

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

Size-Exclusion Chromatography for Preparative Purification of Biomolecules

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

A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications

The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.

Videos

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Standards/Regulations

EMA Collaborates with Physicians

The agency holds a workshop to strengthen collaboration with healthcare providers.

Fresenius Kabi Recalls Sensorcaine-MPF Injection, USP

The company voluntarily recalls product due to particulate matter.

FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins

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

Analytics

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.

Size-Exclusion Chromatography for Preparative Purification of Biomolecules

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

Single-Use Systems

GE Healthcare Delivers Modular Biopharma Facility to China

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

Univercells Partners with Takeda to Develop Vaccine Manufacturing

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Automation of Single-Use Systems

The automation trend in single-use applications serves to increase process robustness and reduce variability.

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

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.

Vaccine Development Faces Urgency and Challenges

Global outbreaks energize vaccine R&D and drive production modernization.

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