Manufacturing, Monoclonal Antibodies

Vaccinex will present new biomarker data from the Phase 1b/2 SIGNAL-AD trial of pepinemab — a humanized IgG4 monoclonal antibody targeting Semaphorin 4D — at AAIC 2026 in London on July 13, showing that SEMA4D blockade regulates glial biomarkers associated with disease progression in early Alzheimer's disease, while outlining plans for an enlarged Phase 2b SIGNAL-AD2 study.

Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.

During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss how advances in radiopharmaceutical manufacturing, cancer biology, and specialty logistics are enabling the expansion of targeted radiopharmaceutical therapies into larger patient populations and broader oncology indications.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

As the ADC market races toward a projected $32 billion valuation, manufacturers face a precision imperative, as integrated CDMO partnerships, advanced analytics, and emerging technologies like AI and continuous manufacturing may hold the key to unlocking the next wave of oncology breakthroughs.

Risk-based ADC cleaning validation must integrate degradation profiling, HBEL-aligned analytical methods, and dual large/small molecule strategies for facility safety, according to STERIS technical services director, Paul Lopolito.

The SK bioscience–Gates MRI agreement highlights how scalable mAbs could broaden infant RSV prevention beyond high-income markets.

Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

Abzena’s antibody platform enables Orion to streamline biologics development, showcasing trends in scalable, risk-reduced manufacturing for the industry.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

Under the agreement, Shilpa will undertake development and commercial supply for a novel checkpoint inhibitor for immuno-oncology indications.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

Bora said it will be involved in stages ranging from chemistry, manufacturing, and controls strategy through to clinical development.

The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.

Lonza’s Synnafix has licensed its ADC technology to BigHat Biosciences, which will combine it with its ML design platform to generate newly designed ADCs.

The best strategy is to use a combination of complementary methods.

Syngene has launched a new protein production platform that offers faster production with lower risk.

Lonza has made a deal with Acumen Pharmaceuticals to manufacture sabirnetug, a mAb that will soon be entering Phase II development for treating Alzheimer’s disease.

ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion.