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Top News

Pfizer to Acquire Medivation

Aug 22, 2016

Pfizer will acquire Medivation for approximately $14 billion.

The CRISPR Patent Debate

Aug 19, 2016

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

US Life Sciences CEOs Upbeat About Industry’s Prospects

Aug 15, 2016

A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.

Biopharma News

AMRI Licenses CRISPR from the Broad Institute

Aug 24, 2016

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

Pfizer to Acquire Medivation

Aug 22, 2016

Pfizer will acquire Medivation for approximately $14 billion.

Casebia Therapeutics Begins Operations

Aug 19, 2016

The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.

Standards/Regulations

The CRISPR Patent Debate

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

Public Health Organizations Pen Letter to House and Senate Committees

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

Zhejiang Medicine Receives FDA Warning Letter

The Chinese facility was cited for data integrity violations.

Industry News

Sagent Pharmaceuticals Issues Nationwide Recall

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

The CRISPR Patent Debate

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

South Tees Bio-Incubator Launches in the UK

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

Supplier News

Zenith Technologies Expands US Presence

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

Agilent Plans Expansion of Oligo Manufacturing Capacity

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

Irvine Scientific Launches BalanCD HEK293 System for Large-Scale Expression of Proteins and Viral Vectors

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

Protein Aggregation Studies

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

By Lisa Newey-Keane

The use of orthogonal methods to SEC is discussed; examples show how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation Matrix

By Hui Xiang, Derek Chan, Ronald Bates

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

By Ciaran Murphy

Resonant mass measurement can be used to detect and quantify the formation of protein subvisible particles and to detect and quantify any silicone droplets in a formulation.

Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates

By Mark Cornell Manning, Ryan R. Manning, Ryan E. Holcomb, Charles S. Henry, Glenn A. Wilson

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Upstream Processing

Alnylam Moves Forward on Multi-Product RNAi Facility

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

Portable Device Delivers Biopharmaceuticals on Demand

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

Novo Nordisk Expands Insulin Manufacturing Facility in Denmark

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Downstream Processing

Protein Impurities Pose Challenges

Multiple methods are required for detecting and removing protein impurities.

Portable Device Delivers Biopharmaceuticals on Demand

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

Avitide Plants Flag at Former Merck Location

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

BioPharm eBooks

Outsourcing Resources
Mergers and acquisitions, the emergence of biosimiliars and cell therapies, complex supply chains, and increased regulatory scrutiny are a few factors shaping practices in the contact services market. The editors of BioPharm International examine recent trends, activities, and prospects for contract services on the scientific and business fronts in this special ebook issue.  
View ebook

 

 

Videos

Sponsored Videos

 

Sponsor's E-Books

 

Fundamental UHPLC Workflows for Biotherapeutic Characterization
The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this e-book, experts explain recent advances in UHPLC, and the basics of glycan analysis. View E-Book

 

 

Analytics

Analysis of Glycosylation in Biosimilars

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

Protein Impurities Pose Challenges

Multiple methods are required for detecting and removing protein impurities.

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

Formulation

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

Are Oral Peptide Drugs on the Horizon?

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

Forced Degradation Studies for Biopharmaceuticals

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Single-Use Systems

The Flexibility of Small-Scale Single-Use Bioreactor Solutions

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

Integrating Single-Use Systems in Biopharma Manufacturing

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

Bioprocessing Technology Marches On

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

mAb Development

Generating a Fully Processed Antibody

The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.

Novartis Expands Biologics Production in France

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

Vaccine Development

Funding for Zika Vaccine Hinders Development

Zika vaccine development is hindered by technical challenges and funding shortfalls.

NIH-Backed Yellow Fever Vaccine Trial Announced

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

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