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Top News

Takeda Launches Medicines Access Strategy in Regions with High Unmet Medical Needs

Aug 26, 2016

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

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.

Biopharma News

Competition and Drug Pricing

Aug 30, 2016

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

Takeda Launches Medicines Access Strategy in Regions with High Unmet Medical Needs

Aug 26, 2016

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

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.

Standards/Regulations

Efforts Accelerate to Streamline Postapproval Change Process

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

PDA Issues Call to Action for Faster Postapproval Changes

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

Compounding Pharmacy Warned Over a Variety of Violations

FDA issued a warning letter to College Pharmacy for multiple violations.

Industry News

Competition and Drug Pricing

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

CPhI’s Pre-Connect Congress Outlines Pharma Trends

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

Compounding Pharmacy Warned Over a Variety of Violations

FDA issued a warning letter to College Pharmacy for multiple violations.

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

Modeling Bioreactor Performance

Model effectiveness is determined by the quality and composition of the data inputs.

Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology

Advances in cell culture media technology have helped achieve safer biologics.

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.

Downstream Processing

Process Chromatography Selection for Downstream Processing Applications

Industry experts discuss best practices for selecting a separation technology.

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.

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

Implementing a Dual Approach to Protein Characterization

Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.

Modeling Bioreactor Performance

Model effectiveness is determined by the quality and composition of the data inputs.

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

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

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

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

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

Process Chromatography Selection for Downstream Processing Applications

Industry experts discuss best practices for selecting a separation technology.

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.

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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