Bioprocess Online

12/01/2022

When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

By Kayla Hannon, TFF Pharmaceuticals, Inc.

When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

11/29/2022

2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year.

This episode of the finds us getting the inside story from Umoja Chief Operating Officer David Fontana, whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS.

Fontana shares how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.

In partnership with Cytiva.

11/25/2022

There are more than 260 genes known to cause inherited retinal diseases, and Opus Genetics’ discovery and development work are leaving none of those stones unturned. The company’s genesis story is unique, though replicable and representative of a greater trend among emerging biopharmaceutical companies.

Featuring Ben Yerxa

There are more than 260 genes known to cause inherited retinal diseases, and Opus Genetics’ discovery and development work is leaving none of those stones unturned. The company’s genesis story is unique, though replicable and representative of a greater trend among emerging biopharmac...

11/23/2022

Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

By BioPhorum

Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

11/22/2022

is brought to you by Bioprocess Online in partnership with Cytiva. Check out this week’s episode featuring Nutcracker Therapeutics’ Chief Business Officer, Dr. Geoff Nosrati.

11/21/2022

In the entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “ ” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

By Dr. Tim Sandle

In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the....

11/18/2022

Computer-aided 3D modeling enables quick assessment of previously undiscovered protein binding sites and helps scientists at Gain Therapeutics marry them to the correct therapeutic molecules. Find out how the approach works, and its role in accelerating the company’s path to the clinic in Parkinson’s disease from Gain CEO Matthias Alder.

Computer-aided 3D modeling enables quick assessment of previously undiscovered protein binding sites and helps scientists at Gain Therapeutics marry them to the correct therapeutic molecules. Find out how the approach works, and its role in accelerating the company’s path to the clinic in P...

11/17/2022

The pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are seeing more patent activity now, and how should biotech companies mitigate patent risks? Attorneys from Neal Ge**er and Eisenberg share their insights.

By Kevin OConnor, Ph.D. and Michael Harlin

The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Ge**er Eisenberg share t...

11/16/2022

It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

By Lea Joos, The Government of Upper Bavaria

It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

11/16/2022

We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.

By Alexander Titus, Ph.D., Colossal Biosciences

We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.

11/16/2022

AviadoBio is building a pipeline of investigational gene therapies for neurodegenerative diseases. Its lead preclinical candidate is AVB-101 for GRN frontotemporal dementia (FTD-GRN). It’s an intra-thalamic gene supplementation therapy, and as it heads to clinical trials, it's being overseen by a ladder climber who's seen it all.

Featuring Lisa Deschamps

AviadoBio is building a pipeline of investigational gene therapies for neurodegenerative diseases. Its lead preclinical candidate is AVB-101 for GRN frontotemporal dementia (FTD-GRN). It’s an intra-thalamic gene supplementation therapy, and as it heads to clinical trials, it's being ove...

11/15/2022

You read, watch, listen, travel to conferences and events, and learn from all of it. But none of those is the leading information source for those seeking it. What medium do most biopharma leaders actively seek when it’s learning they’re yearning for? Conversation.

You read, you watch, you listen, you travel to conferences and events, and you learn from all of it, but none of those are the leading source of information for those who seek it. What medium do most biopharma leaders actively seek when it’s learning they’re yearning? Conversatio...

11/15/2022

are a scourge. They're vectors of multiple serious and debilitating diseases. Evolution has made them perfectly adept at attaching to their hosts — and potentially spreading those diseases virtually undetected — that ability owing to anti-inflammatory and anesthetic proteins in their saliva.

But the emerging Akari Therapeutics thinks there's a broad range of medicinal value in those proteins. They've painstakingly developed a recombinant version of one such tick saliva-derived protein, called , and put it to work in phase 3 trials to treat rare but deadly severe hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

On this week's episode of the , Akari President & CEO Rachelle Jacques tells us about the redeeming qualities of tick saliva and how her company is putting it to work.

In partnership with Cytiva.



https://www.bioprocessonline.com/doc/tick-derived-therapeutic-molecules-with-akari-therapeutics-rachelle-jacques-0001?utm_source=editorpost&utm_medium=link&utm_campaign=socialmedia

11/10/2022

Vaxxinity, small as it may be on the greater pharma landscape, is carving out positions as innovator, disruptor, and leader in what CEO Mei Mei Hu, J.D. refers to as the third biologic revolution.

Vaxxinity, small as it may be on the greater pharma landscape, is carving out positions as innovator, disruptor, and leader in what CEO Mei Mei Hu, J.D. refers to as the third biologic revolution. Here, she shares Vaxxinity's position on immunotherapeutic vaccines in the context of traditiona...

11/08/2022

Earlier this month, Surface Oncology shared that it will open the second stage of its monotherapy trial of SRF388, an antibody targeting IL-27, on the heels of a promising phase 2 data readout.

Shortly before that release, the caught up with Surface's CSO Vito Palombella and CEO Robert Ross in the company's Cambridge, MA HQ.

We discussed the first-of-its-kind target, the company's "product versus platform" strategy and how it fits in the industry's current "platform" vibe, the finer points of building and maintaining a startup bio culture, the difference between that Bob Ross and the Rob Ross, M.D., and a whole lot more.

In partnership with Cytiva.

11/01/2022

MIT-born startup Elicio Therapeutics' novel Amphiphile Technology Platform is designed to directly engage the lymphatic system in the deployment and delivery of therapeutic payloads.

The caught up with Chief Scientific Officer Peter C. DeMuth, Ph.D., Ph.D. at Elicio HQ in Boston to learn how the platform works, and how it's driving rapid clinical progress for the company's robust pipeline of therapeutic vaccines in , as a cell therapy amplifier in liquid and solid tumor indications, and in prophylactic vaccines for infectious diseases like COVID-19.

Dr. DeMuth also shares his journey as a young scientific founder, how he's managed the transition from academic scientist to the C-suite, and how he leans into his scientific training to make a killer home brew.

In partnership with Cytiva.

10/28/2022

The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a guide to adopting that vision.

By BioPhorum

The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a...

10/28/2022

When Sarah Howell joined Arecor as COO in 2011, she brought with her many years of drug development experience — and commercial success — honed at big pharma companies including GSK, UCB, and BTG. What she didn’t bring with her was experience in the C-suite. Her time in the big leagues had been spent on another C-level: CMC. Now she's CEO. Here's what she learned during the transition.

Sarah Howell, Ph.D. joined Arecor as COO back in 2011. She brought drug development experience—and commercial success—honed at big pharmas including GSK, UCB, and BTG. What she didn’t bring with her was experience in the C-suite. Hers had had been spent on another C-level:....

10/27/2022

A look at NIIMBL's commitment to nurturing the skilled workforce the industry desperately needs now — and will need even more as it moves into the development and production of increasingly complex ATMPs and multi-modal therapeutics.

Turning academic interest in biology into careers in biopharma: A look at NIIMBL's commitment to nurturing the skilled workforce the industry desperately needs now—and will need even more as it moves into the development and production of increasingly complex ATMPs and multi-modal thera...

10/25/2022

Anat Binur, Ph.D., is CEO and Co-Founder at Ukko, where she's leading an effort to reverse-engineer the proteins that induce an immune response in people who suffer from food allergies.

The effort at Ukko is deeply rooted in and the company leverages artificial intelligence to analyze proteins taken directly from patients' blood in an effort to determine the specific attributes of the proteins that trigger an immune response. Then, it applies a unique combination of compute power and biology to identify and understand the changes it wants to engineer and predict the best possible designs.

Learn how Ukko fosters a culture of IT and biology collaboration and what lured this dynamic entrepreneur into biopharma on this episode of the .

In partnership with Cytiva.

10/25/2022

For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.

By Dr. Tim Sandle, Ph.D.



For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.

10/21/2022

NIIMBL Director Kelvin H. Lee, Ph.D. illustrated the power of consortia and public/private partnerships in advancing next-generation approaches to ATMP manufacturing and demonstrated how the Institute isn’t just talking — it’s building.

NIIMBL Director Kelvin H. Lee, Ph.D. illustrated the power of consortia and public/private partnerships in advancing next-generation approaches to ATMP manufacturing, and demonstrated how the Institute isn’t just talking — it’s building.

10/18/2022

In a particularly candid , 4BIO Capital Managing Partner Dmitry 'Dima' Kuzmin and Ray Therapeutics, Inc. Co-Founder & CEO Paul Bresge share the recipe for a successful relationship between firm and startup.

Bresge offers insight into VC engagement strategy and pitch, and Kuzmin dishes on what investors look for in terms of "fundability" and what throws red flags, such as — perhaps ironically — a CEO like Bresge who has a deep and incredibly personal connection to the indication he's pursuing. In real and tangible terms, the pair also discuss what constitutes a material, cultural match.

In partnership with Cytiva.

10/14/2022

In conference event programming, in the trade press, and in water cooler conversation we’re making too many generalizations — which in turn create misperceptions — about the so-called biopharmaceutical manufacturing “capacity” crunch.

In conference event programming, in the trade press, and in water cooler conversation we’re making too many generalizations—which in turn create misperceptions—about the so-called biopharmaceutical manufacturing “capacity” crunch.

10/14/2022

Check out for a discussion on the application of process analytical technologies in biopharma manufacturing featuring Paul Testa, Kyowa Kirin, Barrett Fallentine, Pharmatech Associates, and our own Matthew Pillar.

Supported by Sartorius.