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BioPharm International
January 07, 2020
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Top BioPharm International News Stories of 2019

FDA Challenges USP Standards for Biologics

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
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FDA Approves First Vaccine for Dengue Disease

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
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World’s First Malaria Vaccine Launched in Malawi

The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.
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AstraZeneca Announces Organizational Changes

Company to focus on innovation, growth, and productivity with creation of new units.
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Bristol-Myers Squibb to Acquire Celgene in $74-Billion Deal

Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
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NIIMBL Announces New Projects and Funding for Biopharma Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.
/ read more /



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Danaher to Acquire GE’s Biopharma Business

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
/ read more /


GSK, Merck KGaA Partner in $4.2-Billion Cancer Immunotherapy Deal

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
/ read more /


Catalent to Acquire Paragon Bioservices for $1.2 Billion

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
/ read more /


Thermo Fisher Scientific to Acquire Brammer Bio

A $1.7-billion acquisition of CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
/ read more /


Top BioPharm International Feature Stories of 2019

A Look at the Affinity Chromatography Landscape

New ligands are being developed to meet the separation and purification needs of next-gen biologics.
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Design Considerations for a Commercial Cell and Gene Therapy Facility

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
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Understanding Leaching from Stoppers into Lyophilized Drugs

Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.
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Taking Therapeutic Antibodies to the Next Level

This article explores the challenges and potential of next-generation therapeutic antibodies.
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Industrializing Cell and Gene Therapies

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.
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Analysis of Residual Impurities in Continuous Manufacturing

Real-time monitoring of product- and process-related impurities remains a challenge.
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Can Nanotechnology Deliver Big Drug Benefits?

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?
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Formulating Biologic Drugs for Sterile Fill/Finish

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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Catching Up Downstream

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.
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Process Validation Sets the Stage for Ongoing Manufacturing Quality

A properly designed validation program will detect variation and ensure control based on process risk.
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Supply Chain Challenges for Single-Use Systems

Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.
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Modeling the Degradation of mAb Therapeutics

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
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Streamlining Upstream Processing: A Good Place to Start

As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
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Considering Alternative Dosage Forms in Biologics

Optimizing the patient experience and technological advances can positively impact adherence.
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Technology Redefines Continuous Processing Efficiency

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.
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ON DEMAND WEBCASTS

Optimizing SEC for Analysis of Antibodies and Antibody–Drug Conjugates
On Demand
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Events

SMi Group’s 12th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2020

January 15–16, 2020

SMi’s 9th Annual Pharmaceutical Microbiology Conference

January 20–21, 2020

RNA Therapeutics Conference and Focus Day

February 18–20, 2020

more events

eBook

Regulatory Sourcebook and Reference, December 2019

In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.

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