The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.
- U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report
- Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers
- Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk
- Valentine’s Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go
- What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know
- FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?
- The 10 Phases Of An Effective CAPA
U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report
Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers
Implementing online water bioburden analyzer (OWBA) technology often includes laboratory microorganism challenge testing to verify that the instrument is suitable for its intended use. This requires the end user to select microorganisms for testing and successfully create quantifiable suspensions of these microorganisms for OWBA analysis. While this would seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.
Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk
The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to high levels of nitrosamine impurities have once again put the spotlight on sourcing strategies and the globalization of the pharmaceutical supply chain. Learn how the Johari Window model can help minimize risk and shrink the unknown risks inherent in any complex manufacturing supply chain.
Valentine’s Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go
We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?
What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know
Rates of investment in the microbiome category are increasing as both venture capital firms like Seventure and pharmaceutical companies like Johnson & Johnson and Takeda make significant investments and establish partnerships with a variety of start-ups that are commercializing novel offerings in the microbiome space.
FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?
At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.
The 10 Phases Of An Effective CAPA
Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.
New FDA Draft Guidance: Qualification Process For Drug Development Tools
The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.
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Considerations When Cleaning Your Tablet Presses & Tablet Tooling
Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Dirty tools cause tableting and product quality-related problems, such as sticking & picking. Keeping tools clean also decreases premature tool, turret and cam wear, and reduces the risk of product cross-contamination. While most cleaning methods can achieve similar results, utilizing an automated cleaning system, such as an ultrasonic wash with rinse and dryer, can ensure tooling is properly cleaned and dried consistently with limited handling and potential for damage. A warm air-drying process is ideal for preventing moisture and corrosion by pushing warm air through areas, such as key slots, punch cups, and die bores, that may not be dried properly with a traditional towel or cloth.
Steps Ahead: Planning For Future Equipment Surpluses From The Point Of Procurement
Planning and preparation are the keys to success in any enterprise, and making plans for the possibility of equipment liquidation from the time of procurement is no exception. There are clear advantages to planning for your facility’s future, especially if it includes the opportunity for cost savings or a new way to look at purchasing budgets.
Five Reasons To Consider Outsourcing Analytical Testing
Leveraging external experts for analytical input provides a cost-effective route to the latest instrumentation, robust and precise measurement, and reliable data interpretation.
Toxic Treatments: Controlling Exposure Risks In ADC Manufacturing
The potency and effectiveness of the ADCs are dependent upon engineered nanoparticles (ENPs), but little is known about the environmental and human health hazards posed by ENPs.
Inspecting On The Edge – Understanding Punch Tip Wear
Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.
Accelerate Process Development With High-Throughput, Single-Use, Fully Automated Bioreactors
Biopharma R&D teams everywhere face the same dilemma in the development of biologics and vaccines: Increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Frequent expert guests Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook. Download this wide-ranging resource and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas, and a whole lot more.More Content Collections
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Global Forum on Neuroscience and Neurological Disorders
March 2 - 4, 2020
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March 2 - 4, 2020
Gene Therapy for Blood Disorders
March 3 - 5, 2020
March 3, 2020
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program
March 4 - 4, 2020
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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
March 10 - 10, 2020
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Cleanroom Microbiology – A Foundational Introduction
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Regulatory GCP Inspections: Preparation, Participation & Follow-up
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Drug Substance Quality Risk Management: A Practical Approach to Identify Critical Quality Attributes and Critical Process Parameters
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