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FDA Seeks Public Comment On Quality Metrics Reporting Program
3/17/2022
The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.
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Key Considerations For cGMP Building Conversions
3/16/2022
As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.
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Single-Use Technologies: A Game Changer For Expanding mAb Production
3/4/2022
A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.
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Restoration Of Immune Balance With Anish Suri, Ph.D., President And CSO At Cue Biopharma
3/2/2022
Cue Biopharma's Anish Suri, Ph.D., explains why the clinical-stage biopharma is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body to transform the treatment of cancer.
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The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition
3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
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Factory/Site Acceptance Testing & Commissioning Responsibilities
2/22/2022
Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.
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REGENXBIO's Nina Hunter, Ph.D. Details The Accelerated Approval Pathway For Gene Therapies
2/16/2022
REGENXBIO's VP of Regulatory and Science Policy, Nina Hunter, Ph.D., shares potential solutions to gene therapies' regulatory roadblocks and why the accelerated approval pathway is so pertinent.
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MIT, BioMarin Collaborate To Weigh DNA Cargo In AAV Vectors
2/15/2022
To realize the full potential of AAV-based therapies, it is necessary to eliminate impurities in the manufacturing process that decrease the efficacy of treatments and increase their cost. A collaboration between MIT and BioMarin developed a way to quantify the light capsids in preparations of AAV-based vectors.
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Data Management: 5 Best Practices For Emerging Biotechs
2/14/2022
Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.
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Pharmaceutical Quality Compliance In 2022: Data Is Paramount
2/11/2022
Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.