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FDA Updates Guidance For Investigating OOS Test Results
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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Overcome Potency Assay Development Challenges In Gene Therapies
4/22/2022
In gene therapy development and manufacturing, developing and validating appropriate potency assays that reflect the mechanism of action acceptable to regulators is a process fraught with challenges. The FDA advocates the use of a matrix approach, and this article shares best practices of this approach.
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Pivoting to Allogeneic CAR-T Therapies with Celyad Oncology’s CMO, Dr. Charlie Morris
4/13/2022
Celyad Oncology’s CMO, Dr. Charlie Morris, shares the benefits and challenges of the allogeneic approach versus the autologous approach and why a non-gene edited shRNA approach may result in better efficacy and safety for CAR-T therapies.
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Rocket Pharmaceuticals CEO Dr. Gaurav Shah On FDA's Clinical Holds On Gene Therapy Trials
3/30/2022
In a new episode from Cell & Gene: The Podcast, Rocket Pharmaceuticals CEO Dr. Gaurav Shah offers his take on why gene therapy developers have been plagued by clinical holds, whether the FDA’s adeno-associated virus (AAV)-focused CTGTAC meeting's takeaways will hold up throughout 2022, and more. Listen now and subscribe so you never miss an episode!
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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.