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Antibody-Drug Conjugates: Increasing Investment In R&D And Partnerhip

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.

EDITOR'S DESK

A Personal Case For Drug Repurposing
Amidst the dealmaking and spectacle of the 41st Annual JP Morgan Healthcare Conference, a bright and personal light was cast on the value of a different kind of collaboration: drug repurposing. There’s a deep vein of patient benefit sitting on pharmacy shelves, and Michael Fajgenbaum, M.D. wants to tap it.

60 Minutes To IND Success

On 1/24/23, Daniela Drago, Ph.D. and Kati Abraham will join us for the discussion, IND Success: Navigate Through The Regulatory Gray, and I hope you do, too. We’ll talk through reasons for clinical holds, offer tips for avoiding and addressing them, and share best practices on ensuring smooth submissions on your journey from development to the clinic.

Big Bio Breeds Startup Leadership

Richard Francis’ arrival at Purespring in 2021 was indicative of a longer-term trend in the biopharma space that’s inciting a bit of a talent exodus from Big Pharma to emerging bio. While he's now returning to his big pharma generics roots, here's what he looked for in a startup leadership opportunity.

Snake Oil Or Slippery CEO?

Nader Pourhassan was just charged with a whole bunch of crimes. At the nucleus of the charges sits Pourhassan’s overzealous—and as it turns out, illegal—oversell of leronlimab, the monoclonal antibody he hyped as an HIV and COVID-19 therapeutic panacea when he was CEO at Cytodyn.

Inside The Altavant/Enzyvant Self-Made Merger

Prior to their merger, Enzyvant and Altavant didn’t have much in common beyond their suffix and their CEO. That CEO is Bill Symonds, Pharm.D., the architect of the merger whose history with the "vants" runs deep. Here, Dr. Symonds shares the company’s strategy and the implications of the combination.

GUEST COLUMNISTS

How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?
Considerations For Microbial Enumeration Methods When Working With CDMOs
In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.
Frequent Deficiencies In GMP Inspections, Part 3
Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?
Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
Considerations For Sterility Test Methods When Working With CDMOs
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.

BIOPROCESSING WHITE PAPERS

Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions
During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

Envisioning The Future Of Analytical Development For Gene Therapies
10/13/2021

Explore how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.
Expediting Early-Phase Development Of Small Molecules: An Integrated Approach
11/1/2022

Small molecule APIs and drug products are more complex and potent than ever. Explore key strategies for efficiently advancing small molecules from API to pre-clinical data and clinical supply.
Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst
8/3/2021

How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.
Analytical Power Tools Open Upstream Bioprocessing Bottlenecks
10/5/2021

Researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.
Choosing Optimal Harvesting Solutions
5/24/2021

Although some harvesting reagents are more common than others, each can impact cell recovery, viability, and functionality. Here, we highlight commonly used harvesting reagents and their advantages.

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BIOPROCESSING APP NOTES & CASE STUDIES

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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.