ARTICLES BY MATTHEW PILLAR

• ADCs: Leading With The Linker

  12/20/2024

  Leo Marx, Ph.D., the Medicinal Chemistry Project and Bioconjugation Manager at Debiopharm, shares his company's rationale for the company's ADC development decisions and why its linker technology is the tip of the spear for those that make the cut.

• Antibodies 2025: Venerable & Naked Or Complex & Multi-Specific?

  12/19/2024

  Antibodies are the biotherapeutic bulwark, the steadfast stalwart in not just oncology, but infectious and chronic inflammatory diseases as well. We consulted with a variety of antibody developers for insight into the challenges and opportunities antibody modalities face in the coming year and beyond.

• Inside Interius' Global Regulatory Strategy

  12/13/2024

  Interius BioTherapeutics' lentiviral gene therapy INT2104, which creates CAR T and CAR NK cells in vivo, headed to clinical trials in Australia where the company dosed a first patient with a B-cell malignancy. CEO Phil Johnson, M.D. gave us a look inside the company's global regulatory strategy.

• Internalizing Nanoparticle Therapeutic Development

  12/3/2024

  De facto approaches to treating immune-mediated diseases aren’t very kind to the immune system itself. COUR Pharmaceuticals is leveraging nanoparticles, a purpose-built platform and in-house expression systems to build antigen-specific therapies that treat the root cause of autoimmune diseases.

• How Cidara Got Its Molecule Back

  10/30/2024

  In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.

• Suppliers Pushing Novel Analytical Methods Testing Forward

  10/17/2024

  The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

• Outsourced Complex Protein Development Demands Special Considerations

  9/20/2024

  Complex protein therapeutic innovators are often orchestrating the work of three, four, or more outsourced manufacturing partners at once. What goes into their selection criteria? Experts from ADC and fusion protein sponsors weigh in, with bonus commentary from a CDMO process development specialist.

• The Peril Of Analytical Methods Transfer

  9/10/2024

  Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, manufacturing equipment or consumables change, and even process development personnel turnover place analytical decisions made early on under a microscope. 

• Complex Protein Development: Assay Early, Assay Often

  9/6/2024

  Experts from FyoniBio, SOTIO, and Vera Therapeutics weigh in with first-hand experience on how process decisions made very early on can influence – beneficially or detrimentally – the efficiency of upstream and even downstream operations in the development of novel protein therapeutics.

• The ADC Market Is Ripening For Disruption

  8/21/2024

  Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out.

• Are You Taking The HPCs In Your ADCs Seriously?

  8/16/2024

  The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.

• Are Bioprocess Equipment Standards A One-Sided Conversation?

  7/31/2024

  Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology

• BPSA's Single-Use Summit Celebrates Its "Stainless" Anniversary

  7/29/2024

  The Bio Process Systems Alliance (BPSA) is devoted to the advance of single-use technologies in biopharmaceutical manufacturing. At its 11th International Single-Use Summit, the explosive growth in single-use was on full display, and the sourcing, safety, sustainability, and application discussions on the agenda were comprehensive.

• Temperature & Containment Controls In ADC Manufacturing

  7/19/2024

  During a Bioprocess Online Live discussion with leaders from a couple of biotechs with Phase 1 ADC assets in the clinic, an audience member asked questions about OEB (occupational exposure bands) and managing the elevated temperatures required of ADC conjugation. We couldn't address them on the call, but here are some resources that might be helpful.

• Antibodies, Linkers, An Uber, And John Wick

  6/28/2024

  The challenges faced by ADC developers after a hundred-year history with the basic concept of the drug makes the recent billion-dollar bets on the modality look all the more dramatic. What gives? Where’s all this confidence coming from? It's not the antibody. It's not the payload. It's the linker.

• Scale And Sustainability In Single-Use Systems

  6/13/2024

  I had the opportunity to cover a lot of ground on considerations for single-use technologies in biopharmaceutical manufacturing with Mark Petrich, Ph.D. when he joined me as a guest expert on the Bioprocess Online Live event Single Use Technologies For Bioprocessing: An Essential Update. Here are some of his insights on single-use scale and lifecycle management.

• Where's The Case For Generative AI In Biopharmaceutical Manufacturing?

  6/12/2024

  The early use cases for AI in the biopharmaceutical industry—at least, the early public use cases—have largely come from R&D, and more specifically, target identification and molecular design. Where are the use cases in biologics manufacturing, supply chain management, QMS, and operations, and what’s holding us back?

• Bioprocessing Technology: You Are The Standard

  5/21/2024

  Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror. 

• 7 Bioprocess Intensification Strategies

  4/23/2024

  “Process intensification” is one of those big umbrella terms that unfairly implies a concept that comes with an instruction manual. It doesn’t. It isn’t prescriptive. It doesn’t have to start in a specific place, and it really never ends.

• Single Use In Biopharma: Beyond Savings & Sustainability

  4/17/2024

  SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.

• Eying Up The Era Of Topical Biologics

  3/19/2024

  Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies. 

• Doubling Down On Biopharma's Growing Skills Drought

  3/13/2024

  The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.

• Debra Weiss, RN: Big Impact In Small, Non-Profit Bio

  3/8/2024

  The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.

• U.S. Biotech Is In For A Protracted Divorce From China

  2/21/2024

  The U.S. imported $6.95 billion worth of pharmaceuticals from China in 2022. That was 8x the amount we imported in 2021. A proposed Act of Congress puts that supply, and U.S. biotech itself, in serious peril.

• 1 In 300 People In The U.S. Is Living With HIV. That's Not Okay With Jeff Galvin.

  2/12/2024

  By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.