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Join Our Team Find out how to explore a career with us. General Management. Human Resources. Contract Staffing Services. Our Capabilities. Talent Acquisition When it comes to learning best practices in talent acquisition, you could not have come to a better place. Talent Retention Employee retention should be at the forefront of every company's radar. Bond Consulting is committed to helping small businesses address their employee.
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This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts. With a rise in bioprocessing demand, the market for cell culture media has also seen a surge in the last few years.
In the first part of this two-part article, we looked at how dependent the U. Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.
Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry. This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so. This article examines five common mistakes you'll want to avoid when dealing with OEE.
Vacuum decay is a test method provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products. Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply.
Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling. With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S. Read about recent enhancements that are helping keep up with these increasing demands.
Non-sterile pharmaceutical products are subject to microbiological examination prior to release and during stability testing. Process validation is one of the most commonly cited Inspectional Observations issued by the FDA. This ebook is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. Get more pharma manufacturing insight with our FREE newsletter sign me up.
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More Featured Editorial. Is The U. A Brief History Of Parenteral Process Validation — How We Got Here Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. Are We Adequately Assessing U. More From Our Expert Columnists. An Introduction To Vacuum Decay Leak Testing Vacuum decay is a test method provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products.
Water Activity Measurements And Microbial Contamination In Pharmaceutical Products Non-sterile pharmaceutical products are subject to microbiological examination prior to release and during stability testing.
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