Bioprocess Online for bioanalytics, biopurification, bioproduction

4 Focus Areas To Modernize Your Cleaning Validation Strategy

The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.

EDITOR'S DESK

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.

From Racecars To Regenerative Medicine

Find out what inspired a mechanical engineer, a U.S. Marine veteran, and a racecar driver to launch a regenerative medicine company manufacturing perinatal tissue allografts and get its products to market at breakneck speed.

GUEST COLUMNISTS

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.
New Approaches For Drug Substance Freezing And Storage
The latest in drug substance-refrigeration technology gives the biopharmaceutical industry options for freezing and storing liquid DS. Here are some insights for optimizing setups based on application, facility, and budget.

BIOPROCESSING WHITE PAPERS

Trends In Single-Use Mixing Technologies
Here we present an overview of the current mixing technology landscape driven by the need for versatile biomanufacturing platforms with increased productivity.

Manufacturing Strategies For mRNA Vaccines And Therapeutics
2/19/2021

mRNA has emerged as a promising modality for a wide range of therapeutics and vaccines and could become the break-through technology of this century. This technology will not only revolutionize the field of vaccine development by allowing a rapid response to disease outbreaks, it will also help to address diseases of unmet medical need with gene therapy approaches or cancer treatments. Learn more with our white paper.
Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer
10/14/2021

Development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.
How Dwell Volume And Extra-Column Volume Impact Method Transfer
9/22/2022

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.
Ultrafiltration Devices And Plates Offer Higher-Throughput Options For Cloning And PCR Workflows
9/13/2021

Standard techniques often involve multiple purification steps, each associated with significant product losses, therefore requiring large amounts of starting DNA to guarantee sufficient vector and insert material to complete subsequent ligation and transformation steps. In this paper, we describe the use of these ultrafiltration devices in various steps of the cloning workflow that can provide a more streamlined process and compare them against traditional methods of subcloning PCR-generated fragments.
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.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.