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Life Sciences eBook: Best Practices for FDA Compliance
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving Good Manufacturing Practice Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
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Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
CDER and Biotech Quality Assessment
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.
FDA Releases Guidance Documents on Risk Information and IND Applications
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.
Amgen Announces Humira Biosimilar Clinical Studies Success
Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.
CDER Discusses Drug Shortage Prevention
FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.
The Medicines Company Acquires Annovation BioPharma
The Medicines Company announced that it acquired all the remaining equity of Annovation Biopharma, including its novel anesthetic ABP-700.
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Developing a Comprehensive Tool Kit for Microbial Identification
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Enhancing Quality and Process Efficiency using Continuous Manufacturing Technology for Drug Substance and Drug Product
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Pharma Supply Chain Security: Are You in Control?
Live webcast: February 25, 2015 at 11AM ET
In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
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 www.pharmtech.com/security |
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Fundamentals of Spray-Dried Dispersion Technology
Live broadcast on: March 19th, 2015 at 11AM ET
Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Attend this webinar to learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.
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Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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Pharmaceutical Technology presents its Process Analytical Technology resource guide combo
A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects
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| 2015 Biopharmaceutical Benchmarking Survey |
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