Top News
Bayer Completes Monsanto Acquisition for $63 Billion
Jun 13, 2018
Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.
Bayer Gets US Approval for $66-Billion Acquisition of Monsanto
May 30, 2018
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.
Novartis Acquires AveXis for $8.7 Billion
May 16, 2018
The acquisition is expected to strengthen Novartis’ gene therapy pipeline.
BioPharm eBooks
Outsourcing Resources 2018 eBook
An annual review of the market for outsourced contract services, regulatory topics, manufacturing, development, and supply chain issues.
View ebook
Biopharma News
Celltrion Resubmits to FDA Its Proposed Biosimilar to Roche’s Herceptin
Jun 20, 2018
The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.
Alexion, Complement Partner to Treat Neurodegenerative Disorders
Jun 13, 2018
Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.
WuXi Biologics to Build US Biologics Production Facility
Jun 13, 2018
WuXi Biologics will invest $60 million to establish a biologics production facility in Massachusetts.
Industry News
Congress Presses FDA to Do More to Combat Drug Shortages
Legislators have requested that FDA do more to prevent drug shortages.
New Immunotherapy Method Brings Complete Regression of Hard-to-Treat Breast Cancer
Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.
FDA Commissioner Outlines Agency's Efforts for Patient-Focused Drug Development
FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
Supplier News
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.
Sartorius Stedim Biotech and Siemens Collaborate on Automation
Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.
Vetter Launches Use-Centered Approach to Improve Injections
Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.
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.
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Sponsored eBooks
QbD and PAT in Biopharmaceutical Development
In this eBook, learn how the adoption of QbD and Process Analytical Technology (PAT) as well as Design of Experiments techniques help biopharmaceutical companies improve efficiency and accelerate time to market.
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Cell and Gene Therapies
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.
GE and CCRM Partner with DiscGenics on New Cell Therapy
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
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
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.
Wuxi Biologics to Install Large-Scale Single-Use Bioreactor
The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.
Vaccine Development
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.
WHO Vaccinates Against Ebola with Merck & Co.'s Experimental Vaccine
World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.
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Outsourcing
Vetter Launches Use-Centered Approach to Improve Injections
Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.
Rentschler Fill Solutions Announces Agreement for US-Market Drug
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
CMOs Expand Manufacturing Capacities
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
Current Issue
Transcriptomics and the Production of Recombinant Therapeutics
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
Let the Learning Commence
By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.
Meeting the Challenge of Patient-Centered Clinical Trials
Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model’s impact.
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.
CPhI Biopharma News
China’s Pharma Growth Potential to Drive Attendance at CPhI China
Internationalization and regulatory reform are driving growth and investment China.
Serialization Expert Rick Seibert Presents at CPhI North America 2018
Serialization technology and implementation expert Rick Seibert will present an insight briefing on recent serialization challenges at CPhI North America in Philadelphia, PA.
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