Top News

Roche to Acquire Foundation Medicine for $2.4 Billion

Jun 20, 2018

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Sanofi Completes $4.8-Billion Ablynx Acquisition

Jun 20, 2018

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

Bayer Completes Monsanto Acquisition for $63 Billion

Jun 13, 2018

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.

BioPharm eBooks

Outsourcing Resources 2018 eBook
An annual review of the market for outsourced contract services, regulatory topics, manufacturing, development, and supply chain issues. 
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Biopharma News

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

Jun 22, 2018

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Roche to Acquire Foundation Medicine for $2.4 Billion

Jun 20, 2018

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Sanofi Completes $4.8-Billion Ablynx Acquisition

Jun 20, 2018

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

Industry News

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

EMA Modernizes Orphan Drug Process

The agency launched a secure online portal for orphan drug designation applications.

FDA Publishes User Fee Guidance

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

Supplier News

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Gilead Sciences, Hookipa in $410-Million Partnership for HIV, Hepatitis B Immunotherapies

The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.

Upstream Processing

Transcriptomics and the Production of Recombinant Therapeutics

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Bioreactor Monitoring: More to Measure than Glucose In, mAb Out

This article discusses affinity capture for tier determination and surveys a broad collection of commonly and less commonly used assays to analyze cell culture media.

Managing Uncertainty in Continuous Biomanufacturing

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Downstream Processing

Challenges in Cell Harvesting Prompt Enhancements

Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.

Putting Viral Clearance Capabilities to the Test

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

Managing Uncertainty in Continuous Biomanufacturing

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Standards/Regulations

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

Understanding Validation and Technical Transfer, Part 2

A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.

Sponsored Videos

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QbD and PAT in Biopharmaceutical Development
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Cell and Gene Therapies

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.

Fujifilm Opens Collaboration Center

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

Analytics

Transcriptomics and the Production of Recombinant Therapeutics

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Bioreactor Monitoring: More to Measure than Glucose In, mAb Out

This article discusses affinity capture for tier determination and surveys a broad collection of commonly and less commonly used assays to analyze cell culture media.

Wyatt Technology Announces Executive Team Changes

Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.

Formulation

Transcriptomics and the Production of Recombinant Therapeutics

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Automation Trend in Fill/Finish Reduces Contamination Risk

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.

Anti-methamphetamine Antibody Moves to Clinic

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Single-Use Systems

WuXi Biologics to Build US Biologics Production Facility

WuXi Biologics will invest $60 million to establish a biologics production facility in Massachusetts.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.

Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

mAb Development

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

GE Speeds Up Production of Viral Vector-Based Therapeutics

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

Amgen to Build Next-Generation Biomanufacturing Plant

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

Vaccine Development

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Research Shows Promise for Syphilis Vaccine

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

New Research Hub Tackles Access to Vaccines

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

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