A sound scientific approach can be taken for running experiments and qualification of microbiological methods. This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection, specificity, and quantification.
- The US Drug Pricing System Needs to Be Fixed
- FDA’s Longtime Approach To New Chemical Entity Designations Now Codified
- The “Resiliency Roadmap” — Next Steps For FDA Inspections
- From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs
- Qualification Considerations For A “Factory-in-a-Box”
- Patenting Antibodies: The 4 Tactics To Use In 2021
- What Do Artificial Intelligence And Continuous Validation Have In Common?
The US Drug Pricing System Needs to Be Fixed
Reforms to the U.S. drug pricing environment are required, but to improve patients’ health outcomes, reforms must be grounded in a comprehensive understanding of the current drug pricing system. Otherwise, policymakers will make things worse, not better.
FDA’s Longtime Approach To New Chemical Entity Designations Now Codified
New chemical entity (NCE) designations are extremely important to small molecule pharmaceutical developers: they provide a five-year exclusivity period assuring no competition to a new drug product from generics, with or without patent protection. Recently, President Biden signed into law the Ensuring Innovation Act to clarify when a new drug may be granted NCE status.
The “Resiliency Roadmap” — Next Steps For FDA Inspections
More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.
From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs
The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.
Qualification Considerations For A “Factory-in-a-Box”
The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
Patenting Antibodies: The 4 Tactics To Use In 2021
With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.
What Do Artificial Intelligence And Continuous Validation Have In Common?
Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.
Outlook: Biotech In 2021 & Beyond
Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.
PHARMA ONLINE WHITE PAPERS
Understanding And Controlling Raw Material Variation In Cell Culture Media
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
Is Your Partner Prepared For Your Scale-Up Challenges?6/26/2019
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, it is critical you find a partner that can help you overcome the challenges.
Evaluating A Chemical Fume Hood For Containment Of Solids, Liquids, And Vapors Using ASHRAE 110, HAM, And ISPE Methods10/22/2019
Originally designed around 350 years ago to contain accidents and prevent bad odors in the laboratory, the fume hood has become a device that can routinely produce control levels of vapors down to the part-per-billion level. In this study, Flow Sciences chose to meld existing techniques centered around ASHRAE 110 with widely-accepted particulate containment measurement techniques. The Flow Sciences fume hood, when used in conjunction with good lab practices, is capable of providing workers with the protection they need for applications using solids, liquids and gases.
Standardizing Vein-To-Vein Logistics To Reach More Patients2/24/2020
Collaboration is key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.
The Importance Of An Integrated Informatics Solution For Life Science Organizations4/21/2021
Over the last few decades, replacement of outdated paper-based data management systems has been identified as a means to accelerate this process. While the implementation of electronic systems led to reduced cycle times and compliance risk, issues remain with systems existing in departmental silos and non-standardization of data across the drug development continuum. To satisfy the requirement of drug development companies for efficient data and technology transfer, standardization of data and technology transfer across the entire pharmaceutical product lifecycle is needed.
Critical Factors For Large Molecule Fill/Finish Manufacturing10/1/2019
The industry has entered a new drug development era with the explosion of the biologics market. Large molecules require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing changes in the manufacturing process.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat “human error” in the workplace.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.