Biologics - Pharmaceutical Technology

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Biologics

Biotech Industry Forms International Council

July 10, 2014

New International Council on Biotechnology Associations advocates biotechnology growth.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA Licenses First US Facility for Cell-Culture Influenza Vaccines

June 16, 2014

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

Outsourcing Trends in Biopharmaceutical Manufacturing

February 1, 2014

Pharmaceutical Technology

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

Will CMOs Provide Sufficient Capacity for Growing Biologics Demand

January 31, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody Fragments

January 2, 2014

Pharmaceutical Technology

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

The Impact of Biosimilars on the Innovator Market

December 4, 2013
Pharmaceutical Technology

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

The Importance of Characterization in Biosimilars Development

September 2, 2013

Pharmaceutical Technology

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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