Recently, USP held a bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products that are also used for potency. This article recaps the key insights from the workshop.
- Your How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems
- FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
- How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
- 2022 Outsourcing Trends In Biopharmaceutical Manufacturing
- The Coming Wave Of Radio(bio)pharmaceuticals
EDITOR'S DESK
-
IPSCs For Democratized Cell Therapy
Dr. Daniel Teper and his team at Cytovia Therapeutics have developed a unique combination of candidates designed to improve access to safe and affordable "off-the-shelf" cell therapies. Founded just four years ago, the company is preparing multiple clinical trials of IPSC-derived therapies, which Dr. Teper says lend to a consistent, scalable manufacturing process.
By way of its business strategy, Context Therapeutics willfully embraces difficult breast, ovarian, and endometrial oncology development projects. That’s what creates differentiation and value in a therapeutic area that’s desperately lacking both, says VC-turned-CEO Martin Lehr.
Ring Therapeutics is building a first-of-its-kind viral vector platform based on a commensal virus that flies under the immune system’s radar. If its odds-beating CEO is any indication of its success, the company just might beat the immunogenicity challenge.
Dr. Jessica Grossman’s life’s work has been dedicated to women’s health, maternal health, family health, and inspiring the advance of female leadership in life sciences. She’s paving that path in her current role as CEO at IgGenix, which is pioneering genomically-engineered antibodies for the treatment of severe allergies.
SparingVision CEO Stephane Boissel took the reins of a fledgling, single-asset gene therapy company born of academic research and quickly built a well-funded startup with a deepening pipeline of ocular disease candidates. He told the Business of Biotech how it happened.
GUEST COLUMNISTS
-
FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
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.
-
Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
-
FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
-
How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
-
2022 Outsourcing Trends In Biopharmaceutical Manufacturing
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
-
FDA Publishes Guidance For Biopharma Container And Carton Label Design
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
-
How To Test Master Cell Banks As A Starting Material For Gene Therapies
BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.
-
Assessing Extractables & Leachables In Parenteral Drug Products
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.
BIOPROCESSING WHITE PAPERS
-
Orchestration For Remote Access And Monitoring Of Bioprocess Unit Operations
Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore future-ready, flexible, deployable, and reconfigurable elements that enable connectivity among equipment.
-
Monoclonal Antibody Manufacturing: Build Or Outsource?2/19/2021
The standardization of biologics manufacturing processes has given product developers multiple viable options for producing monoclonal antibodies (mAbs), including building an in-house mAb production system or partnering with a contract biologics manufacturer.
-
Developing Effective Procedures In Drug Manufacturing11/10/2021
This paper explores the change management, risk management, and knowledge management processes and how they integrate with one another to help you construct proper procedures for your organization.
-
Product Development For Oral Solid Dose Using Continuous Manufacturing10/30/2020
A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.
-
Explore Protein Function Using Surface Plasmon Resonance (SPR)5/20/2021
We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.
-
A Guide To Pharmaceutical Quality Management6/16/2022
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
BIOPROCESSING APP NOTES & CASE STUDIES
- Have CDMO Selection Criteria Changed Over the Past Five Years?
- Optimizing Feed Strategies: A Scalable Process
- Jumpstart Cell & Gene Therapy Commercialization With SUT Learning
- Overcoming Method Transfer Challenges Between Your Lab And Contract Organization
- Quantification Of A Hybrid Purifier Value In mAb Manufacturing Process
BIOPROCESS ONLINE CONTENT COLLECTIONS

From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- A Mixed-Mode Approach - Alternative To A Three-Step mAb Purification Process
- Addressing Upstream Cell Culture Challenges As A Community
- Use Of Mass Spectrometry To Assist in Biopharmaceutical Process Development
- Viral Safety Of Biologics: What's Changing With The ICH Q5A Revision?
- Controlling Essential Amino Acid Levels In CHO Cell Cultures
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 07.01.22 -- mAb Manufacturing: Overcoming Platform Inefficiencies
- 06.30.22 -- Simplify And Accelerate The Development Pathway For APIs With Low Solubility
- 06.30.22 -- Calculating Process Control ROI For Improved Costs And Timelines
- 06.29.22 -- Clinical Supply Optimization And Comparator Local Sourcing Strategies
- 06.29.22 -- FDA Guidance For Biopharma Container Labels & Carton Labeling Design