"Should we build out an internal group of scientific expertise or delegate work to external vendors?," is a question that this author has faced in his career. He shares key considerations building protein science teams.
- The 2 Factors Driving A Surge In Aptamer Use In Drug Discovery
- Here's How USP mAb Standards Support Fast-Evolving Platform Approaches
- Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing
- FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors
- Best Practices For Raw Material And Supplier Management For Cell & Gene Therapy Manufacturing
- All You Need To Know About Contamination Control Strategies, Part 2
- Part 2: What You Should Expect from A High-Functioning CDMO
Anatomy Of A Biopharma VC Deal
Why does a venture capitalist choose to fund a biopharma company? What prompts them to choose not to? And why should (or shouldn't) a biopharma company take a VC's money?
A recent clinical study of an eyedrop formulated with Grifols’ Immunoglobulin-based Flebogamma DIF offers cause for optimism among multiple stakeholders. It could become the first-approved topically administered biologic therapy for dry eye disease.
Mapping the adeno-associated virus (AAV) therapeutic space gives us a glimpse into indication priorities for gene therapy, and a look at whose got their fingers in which partners’ pots. Check out this interactive graphic from DeciBio Principal Carl Schoellhammer, Ph.D. It's not only instructive, its kind of therapeutic to play with.
How does a biopharma business that’s potentially years away from its first shot at therapeutic sales revenue thrive in a high-inflation, high-interest, supply-constrained business environment?
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.”
Here's How USP mAb Standards Support Fast-Evolving Platform Approaches
Industry-accepted reference materials give drug manufacturers a competitive edge. Data shows that first-in-class mAbs hold a market lead over later entrants. This article discusses the benefits of using well-characterized reference materials instead of spending time and resources to develop them from scratch.
Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing
During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.
FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors
An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.
Best Practices For Raw Material And Supplier Management For Cell & Gene Therapy Manufacturing
One aspect of the complex cell and gene therapy manufacturing process is often neglected or underestimated: the sources and quality of the materials used. Employ this article's best practices and strategies for ensuring supply continuity and the phase-appropriate qualification of materials.
All You Need To Know About Contamination Control Strategies, Part 2
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.
Part 2: What You Should Expect from A High-Functioning CDMO
In their second article of this two-part series, the authors detail how to make the partnership between the cell and gene therapy company and CDMO mutually successful.
Let’s Explore Packaging For Aseptic Manufacturing
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
Optimizing Digitalization To Accelerate Your R&D
Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.
BIOPROCESSING WHITE PAPERS
How Dwell Volume And Extra-Column Volume Impact Method Transfer
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.
Addressing The Challenge Of Scalability In Viral Vectors8/10/2021
Learn more about a wide range of solutions to facilitate the delivery of gene therapy by addressing the challenges related to viral vector manufacture and scale-up.
How Controlled Freezing Becomes Reality2/17/2022
Controlling the freezing behavior of bulk drug substance is the ultimate goal in biopharma manufacturing. This study demonstrates the impact of ice front growth speed on scalability of freezing protein solutions.
Understanding Perfusion Terminology6/7/2021
To evaluate whether a perfusion application will work in a production process, standardized terminology is critical. This white paper explains key terms that are essential for understanding the process.
Biosafety Testing And Quality Control Requirements For Lentiviral Vectors9/26/2022
Learn more about manufacturing principles of LV vectors, and testing requirement regulatory considerations with a particular focus on the replication competent virus assay and infectious titer assay.
Organoids: Ideal Model Systems For Disease And Drug Screening?6/22/2021
Successful organoid formation is dependent on many factors, all of which are crucial in fulfilling the potential of this powerful new tool for personalized medicine.
BIOPROCESSING APP NOTES & CASE STUDIES
BIOPROCESS ONLINE CONTENT COLLECTIONS
Biopharmaceutical supply chain strategies can be profoundly bespoke, but best practices like redundancy and quality risk management offer a starting point. The ideas in this collection of recent articles from Bioprocess Online can help shore up your own network in defense of the next upset.More Content Collections
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- Streamlining Viral Vector Development And Manufacturing For Gene Therapies
- Learn About The Development Of Protein A Continuous Chromatography
- Transformative Power Of Insights In BioPharma Development
- Overcoming Manufacturing Challenges For Advanced Medicines
- 06.01.23 -- Get Up To Speed In Your UF/DF
- 05.31.23 -- Suppliers Ready To Serve Your Purification Services Needs
- 05.31.23 -- The Generic Sterile Injectables Market Will Double In Value By 2032
- 05.30.23 -- Improving The Speed, Efficiency, And Outcome Of Your Project Through Fit-For-Purpose Quality Management
- 05.26.23 -- Increasing Oral Bioavailability With Solid Form Options