Jon O’Connell

4 Centralized Comparator Sourcing Models To Fortify Supply Chains <p>A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.</p>

In clinical trials, we obsess over how we're getting the investigational drug to the patient.

What about the comparator?

Managing Extractables And Leachables In HPAPI Manufacturing <p>These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.</p>

Two things are happening at once.
1. More ADCs are moving through pipelines than ever before.
2. More companies are using SUT.
That calls for extra vigilance, especially further downstream.
Those polymer tubes can leach harmful contaminants into exceptionally-low-AET product.

Price of first malaria vaccine to be slashed by more than half Drugmakers Bharat Biotech and GSK have committed to reduce the price to less than $5 per dose in endemic countries by 2028.

The price of the world’s first malaria vaccine, RTS,S, will be reduced by more than half — to less than $5 per dose in endemic countries by 2028, according to a commitment by drugmakers Bharat Biotech and GSK on Wednesday. www.devex.com/news/price-o...

Beginner gardener checking in from the eastern side of Zone 6, and I expect cracking will be especially tough to mitigate this year.

Ask The Pros — The Latest In Downstream HCP Mitigation <p>Two downstream biologics processing experts address some of the field&#39;s complex, nagging questions about mitigating host cell proteins.</p>

The biggest impediment to disrupting HCP/mAb binding during protein A chromatography?

Not a lack of science. It might be lousy cooperation.

One scientist tells us that IP considerations complicate a more robust understanding of buffer etc., to mitigate.

www.bioprocessonline.com/doc/ask-the-...

Some of you never read "If You Give a Mouse a Cookie," and it shows.

FDA named its new AI tool meant to accelerate the review process after a cartoon character who freezes everything she touches. I’m assuming this is a coincidence.

Live updates: HHS will cut 10,000 jobs as part of a major restructuring plan Canadian Prime Minister Mark Carney said Wednesday that U.S. President Donald Trump’s auto tariffs are a “direct attack” on his country and that the trade war is hurting Americans, noting that American consumer confidence is at a multi-year low.

BREAKING: The United States' top health agency announces it will cut 10,000 jobs as part of a major restructuring plan.

Using Digital Shadows To Reinforce Downstream Modeling <p>This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.</p>

This week, I learned about digital shadows 😶‍🌫️ the stepping stones between digital models and fully-functioning digital twins.

Lund's Daniel Espinoza writes about it for Bioprocess Online.

Automating Digital Twins Implementation In Downstream Bioprocessing <p>One researcher describes a case study in which they simply pressed play on a set of six pre-programmed experiments and returned hours later to a complete data set.</p>

One scientist makes his plea for downstream bioprocessing hardware developers to build in open protocols.

Why Aren't QC Labs Automated? Blame Sample Container Variability <p>Members of the Laboratory Automation Plug and Play group speak up about the factors they see holding back quality control labs from achieving more robust automation.</p>

Apple and charging cables convinced me that brand lock-in is the only reason we can't standardize. But maybe that's true only for phones.

For pharma companies standardizing sample containers as they try to automate, Takeda's Adam Wolf offers another reason.

Recertifying new equipment is no fun.

Children stop being small after roughly nine to 10 years. Bummer. You almost made it.

Count On Data Integrity Auditors Making These 10 Requests <p>Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.</p>

One day, the data auditors will come.

When they do, they won't just be looking at site-wide systems. They might dig into specific applications or even your vendors' systems. 🔍

Dr. Eva Kelly at ERA Sciences shares her list of the top 10 requests data integrity auditors are likely to make.

Bayer's Supply Network-Centric Approach To Digitalization <p>Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here&#39;s how one company is approaching the monumental task.</p>

Digitalization implementation step 1: Get off paper

Chris Grail at Bayer suggests a process-by-process approach asking which ones can move away from paper records.

Inevitably, some processes will remain paper-based, but a digital archiving system can help ensure compliance.

How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS <p>The company&rsquo;s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.</p>

Atsena Therapeutics wants to overcome the limitations of AAV gene therapy for subretinal applications. It developed a novel capsid that's really good at targeting photoreceptors and spreads beyond the injection site.

Read more about it on Cell & Gene.

Solving The Leukopak Supply Chain Issue With Cryopreservation <p>Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.</p>

Dozens of factors determine whether allogeneic cell therapy makes it from the donor ➡️ processing facility ➡️ patient.

Temperature control is a big one. Broader use of cryopreservation could clean up many of the issues, says starting material expert Jenny Chain.

Read more on Bioprocess Online.

USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli <p>Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP&#39;s General Chapter &lt;509&gt; aims to remedy that.</p>

Impurities — one of the biggest drawbacks of using biological cell lines to make therapeutic proteins.

With the risk of immunogenicity and even oncogenicity, it's important to know about any host cell proteins or host cell DNA and get it out.

USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli <p>Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP&#39;s General Chapter &lt;509&gt; aims to remedy that.</p>

Detecting, characterizing, and quantifying residual DNA in biologics is a common practice, but industry has always lacked a documentary standard — one that will help them meet regulator expectations.

So the USP stepped in to define best practices and put them in a General Chapter.

Embracing An Economic Model For Agile Process Development <p>If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?</p>

Wise CMC leads see the potential for a surge in AI-generated drug candidates and start planning now.

Irwin Hirsh, a knowledge management pioneer, developed a lifetime-value-based model that cans the waterfall method in favor of one based on risk and queuing.

Read about it on Bioprocess Online.