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June 21, 2017

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Multivariate Analysis (MVA) to optimize analysis processes and product quality

The final product quality is influenced by everything that happens during manufacturing, each process step, ingredient, condition of the equipment and even small changes in the environment itself can lead to variations in product quality. The univariate specifications used for characterization of raw materials cannot fully describe quality or influence on the final product, and this allows for problems to go undetected . By developing multivariate models to identify each potential cause of variability, and by adding process analytics, drug manufacturers can establish quality systems that will save time and money. The Unscrambler makes it possible.

	Industry News

Bristol-Myers Squibb to Sell Manufacturing Facility in Ireland to SK Biotek

BIO Elects New Chair

Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance

Valeant Appoints Senior Vice President, Head of Investor Relations and Communications

FDA Accepts Amgen's Supplemental Biologics License Application to Expand Indication for Xgeva to Include Multiple Myeloma Patients

Therachon Receives EMA, FDA Orphan Drug Designation for TA-46 for Achondroplasia

	Featured Articles

ICH M9: Biopharmaceutics Classification SystemBiowaivers ICH M9: Biopharmaceutics Classification SystemBiowaivers The International Conference on Harmonization (ICH) M9: Biopharmaceutics Classification System-based... read more »

The BIOne Benchtop Single-Use Bioreactor System For Mammalian Cell Growth And Recombinant Protein Production As A Robust Model For Bioprocess Development The BIOne Benchtop Single-Use Bioreactor System For Mammalian Cell Growth And Recombinant Protein Production As A Robust Model For Bioprocess Development Distek has developed a benchtop scale SUB system for mammalian cell growth and recombinant protein ... read more »

	Featured Video

Webinar: Harnessing Emerging Technologies to Obtain the Best Chemical Information from Pharmaceutical Products
Webinar: Harnessing Emerging Technologies to Obtain the Best Chemical Information from Pharmaceutical Products
Extraneous material, such as micro-particles, found in the manufacturing stream of biopharmaceuticals must be identified and the root cause must be ... read more »

Webinar: Effective Compressed Gas Contamination Monitoring: Particles and Microbials
Webinar: Effective Compressed Gas Contamination Monitoring: Particles and Microbials
Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of ... read more »

	Featured Products

i-Series Integrated HPLC Systems
read more »

	Featured Whitepaper

Single-Use Powder Transfer for Biopharm Manufacturing
Single-Use Powder Transfer for Biopharm Manufacturing
ILC Dover’s EZ BioPac® system was designed specifically for powder handling in the biopharmaceutical industry. EZ BioPac® vessels feature a large-diameter, open-funnel top for easier and quicker ... read more »

Basic low TOC vials may not always be the best choice
Basic low TOC vials may not always be the best choice
Did you know there are other low-TOC vial options that might be better for your specialty application needs? This Application Note can help you select a vial to provide superior TOC recovery with ... read more »

	Events

Webinar: Public-Private Partnerships -- A Safe Zone for Pre-Competitive Collaboration
Webinar – 06/20/2017
Register today for free! In the run up to the 15th Annual Pharmaceutical IT Congress, Oxford Global are delighted to invite you to participate in a... event details »

Webinar: Application of Multiparticulate Technologies for Drug Delivery
Webinar – 06/21/2017
Multiparticulates are a versatile group of dosage forms applicable to a broad range of drug delivery problem statements. Multiparticulates are highly ... event details »

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