We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
- How Can Life Sciences Navigate M&A In 2023?
- AAV Manufacturing Field: An Interactive Look
- The Global Market Landscape For Peptide Drug Conjugates
- A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
- The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
- Cashing In On Biopharma Collaboration
- Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
What’s In A “Biopharma” Name?
As exciting new modalities, hybrids, and conjugates blur therapeutic lines, let’s not forget what “bio” means, how biologic therapeutics are distinguished, and why they were delineated as such in the first place. Make sure you're not a BINO (Bio In Name Only) when you’re naming your “biotech.”
The FDA is laying the groundwork for standardized, cloud-based electronic submission standards via an initiative that leverages data automation and artificial intelligence. What will it mean to biopharma filers?
Novadip Biosciences CEO Denis Dufrane, M.D., Ph.D. got a crash course in biopharma leadership, but not before he left cell therapy research on his own timeframe. He sat down with Bioprocess Online to tell us what he learned.
DeciBio’s Antibody-Drug Conjugates 2023 Industry Survey points to progress in ADC development. Respondents anticipate lower regulatory, financial, and R&D barriers as the technology matures. Senior Life Science Expert Joe Daccache, Ph.D. gave us an insider's look at the numbers.
After losing his mother to pancreatic cancer, entrepreneur Alex Blyth launched an immuno-oncology company that’s developing a novel allogeneic cell therapy. The company, LIfT BioSciences, recently received a shot in the arm when it was accepted into Johnson & Johnson Innovation’s JLABS network.
The Global Market Landscape For Peptide Drug Conjugates
A peptide drug conjugate is a type of drug molecule that combines a peptide with another molecule, such as a small molecule drug or a protein, to create a new compound. New market research shares key factors and trends driving the market, as well as market segment insights.
The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.
A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.
Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.
Best Practices For Cell Culture Media Fingerprinting
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
Add Efficiency From Development To Validation With Design Of Experiments
A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.
Dispelling 4 Common Myths Of Data Quality Governance
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
Tackling Safety Issues Of Adjuvanted Vaccines
An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.
BIOPROCESSING WHITE PAPERS
Ensuring Resilience: How Life Science Is Reshaping Supply Chains In Response To COVID-19
Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.
How Dwell Volume And Extra-Column Volume Impact Method Transfer9/22/2022
Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
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.
Strengthening The Drug Manufacturing Supply Chain During Extraordinary Times9/9/2022
Learn more about a successful strategy for increasing supply security through improving the resilience of manufacturing operations.
Frontiers In Digital Bioprocessing: Modular Plant Automation And Cloud5/26/2022
As the biopharmaceutical industry is embracing digital transformation and thus evolves in its digital maturity, future-ready concepts will play a leading role in the shift toward bioprocessing 4.0.
Reducing Risk During CAR T Cell Therapy Development And Manufacture1/26/2022
It is essential to identify potential areas for optimization early in CAR T cell therapy development—particularly with respect to equipment, reagents, and analytics.
BIOPROCESSING APP NOTES & CASE STUDIES
- Comparing Standard Microbial Media From A Single Supplier
- Advanced Bioscience Laboratories Inc. (ABL) Scaled Up Lentiviral Production
- Process Development For AAV Vector Production In Suspension Cells
- Applying High Throughput Processes To Optimize AAV Titers
- Levers To Optimize The IVT Reaction For Increased mRNA Yield
BIOPROCESS ONLINE CONTENT COLLECTIONS
Bioprocess Online brings the latest takes on both the progress and the pitfalls of continuous manufacturing adoption in biopharma. Check out our complete and current take on continuous manufacturing in biopharmaceutical environments, all in one package, from seven of the leading minds on the topic.More Content Collections
FEATURED PRODUCTS AND SERVICES
- Mitigate Bioprocessing Limitations with a More Efficient and Sustainable Harvest Solution
- Development Of Protein A Continuous Chromatography
- Solving The Analytics Bottleneck In Cell Line Development
- Break Free From The Protein A Low-Productivity Paradigm
- Overcome The Hidden Complexities Of mRNA Process Development
- 03.28.23 -- Optimize Manufacturing Efficiency And Sourcing Strategies
- 03.27.23 -- Accelerate Your Vision Of BioPharma Digital Optimization
- 03.27.23 -- Tackling Safety Issues Of Adjuvanted Vaccines
- 03.24.23 -- Draft FDA Labeling Guidance Proposes More Clarity For Providers
- 03.23.23 -- Ensuring Success From Early Stage In The Biopharma Business