Top News

FDA Issues Quality Metrics Draft Guidance Document for Comment

Jul 27, 2015

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

Teva Withdraws Mylan Offer, Agrees to Acquire Allergan’s Generics Business

Jul 26, 2015

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

EMA Releases Positive Opinion for GSK’s Malaria Vaccine

Jul 23, 2015

GSK’s malaria candidate vaccine for the prevention of malaria in young children received a positive opinion from EMA.

Biopharma News

New Humira Formulation May Extend Patent Life of Blockbuster

Jul 27, 2015

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

Manufacturers Do Not Report 10% of Adverse Events to FDA within Allotted Time

Jul 27, 2015

A new study published in JAMA Internal Medicine found that manufacturers do not report a portion of adverse events to FDA within the federally mandated time frame of 15 days.

Teva Withdraws Mylan Offer, Agrees to Acquire Allergan’s Generics Business

Jul 26, 2015

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

Industry News

New Humira Formulation May Extend Patent Life of Blockbuster

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

FDA Issues Quality Metrics Draft Guidance Document for Comment

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

Supplier News

World Courier Facility Receives UK Distribution Authorisation

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

CSafe Adds Service Center for Controlled-Temperature Shipping in Switzerland

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Shimadzu Scientific Instruments Names Katsuaki Kaito as President

Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.

Peer-Review Research

Endotoxin Test Concerns of Biologics: The Role of Endotoxin as a Quality Indicator in Biologic Manufacturing Processes

Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.

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

This article demonstrates how resonant mass measurement can be used not only to detect and quantify the formation of protein subvisible particles in a critically important size range but also to detect and quantify any silicone droplets in the formulation.

Advanced Liquid Particle Counters to Measure Aggregated Proteins

Liquid particle counters are ideal for protein aggregation studies.

Upstream Processing

Catalent Licenses Excelimmune’s Antibody Combination Therapy Platform

Catalent licenses Excelimmune’s antibody combination therapy platform to enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biogen Plans Biologics Manufacturing Facility in Switzerland

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

GSK Plans Increase in Antibiotic Production in Singapore

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Downstream Processing

3M Launches Production-Scale Sizes of its Upstream Purifiers

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

Using Single-Use Technologies in Downstream Processing

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

Natrix Introduces New Disposable mAb Purification Column

The new column features Natrix’s signature macroporous hydrogel.

Formulation

New Humira Formulation May Extend Patent Life of Blockbuster

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

Catalent Adds Platform for Antibody Combination Therapies

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Capsugel Completes New Spray-Dried Dispersion Manufacturing Facility

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Analytics

Robust Optimization, Simulation, and Effective Design Space

Approaches to the generation of process models, optimization techniques, and application of a design space are explored.

Endotoxin Test Concerns of Biologics: The Role of Endotoxin as a Quality Indicator in Biologic Manufacturing Processes

Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.

Another In-House Operation Gets Outsourced

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Videos

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CPhI Biopharma News

2015 CPhI Pharma Awards

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.

Experts Join CPhI Panel

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

Standards/Regulations

FDA Issues Quality Metrics Draft Guidance Document for Comment

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

FDA Issues Guidance on Analytics and Method Validation

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

Single-Use Systems

Bioreactor Harnesses Single-Use Process

Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.

Using Single-Use Technologies in Downstream Processing

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

Risk Assessment and Mitigation in Biopharmaceutical Manufacturing

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

mAb Development

BARDA Taps Emergent BioSolutions for the Manufacture of Ebola mAbs

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

Catalent Adds Platform for Antibody Combination Therapies

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Using mAbs to Access Undruggable Targets

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

Vaccine Development

EMA Releases Positive Opinion for GSK’s Malaria Vaccine

GSK’s malaria candidate vaccine for the prevention of malaria in young children received a positive opinion from EMA.

GSK Ships Flu Vaccine

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

EMA Clarifies HPV Vaccine Safety Profile

The European Medicines Agency reviews the safety of human papillomavirus vaccines.