Monoclonal antibodies

AI drug discovery is rapidly reshaping how large-molecule therapeutics are conceived, moving the industry from empirical screening toward intentional, computational design. Recent advances show that artificial intelligence can now propose entirely new antibody structures with levels of precision and functionality approaching those required for real medicines. These technologies increasingly account not only for target binding but also for properties critical to development. As a result, biological targets once considered difficult or impractical for large-molecule drugs are coming back into strategic focus. While clinical adoption will still require rigorous validation and safety testing, the trajectory suggests a fundamental shift in how biopharma innovation will unfold.

AI Comes of Age in Biologic Drug Discovery

The FDA breakthrough decision removes clinical efficacy studies from the biosimilar pathway in suitable cases, underscoring a smarter, evidence-based regulatory approach.

FDA Grants First Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilar

Many lifesaving biopharmaceuticals are suffering from a slump in venture funding. Novel recombinant protein based therapeutics, but also biosimilars are needed to fill the gaps in unmet patient needs. At Mabion we understand how to advance promising biosimilars and novel biotherapeutics to the clinic and from there to patients. Unfortunately, many promising biopharmaceutical innovations spanning novel recombinant protein therapeutics to biosimilars are being held back in the current, limiting funding climate, depriving patients from access to advanced therapies. Yet the urgency to close gaps in unmet patient care has never been greater. That is why we are launching the “Unlocking the Future of Therapeutics” competition a unique opportunity to support and accelerate biologics development and scale up for an oncology-targeted therapeutic. We are offering €500,000 credit in development services to support an exceptional therapeutic project. This can be a novel therapeutic, but might also be a biosimilar drug which expands patients access to lifesaving care. We have partnered with respected academic experts focused on cancer research to select the most promising candidate.

Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs

Cumulative incidence of P. falciparum blood-stage infection during a 6-month malaria season (irrespective of symptoms being present) after a single IV infusion of 10 mg kg−1 of CIS43LS (n = 110), 40 mg kg−1 of CIS43LS (n = 110) or placebo (n = 110). P. falciparum infections were detected by 18S qRT–PCR analysis of DBS collected during scheduled trial visits and unscheduled illness visits when malaria was suspected. DBS were collected before the administration of CIS43LS or placebo on day 0 and then on days 1, 3, 7, 14, 21 and 28 and every 2 weeks thereafter for a total of 24 weeks (day 168). Only DBS collected between days 21 and 168 were included. Estimates of the cumulative risk of infection are plotted along with the 95% CIs (shaded areas).

Single-Dose Monoclonal Antibody Therapy Offers Durable Protection Against Malaria

Worldwide preclinical and clinical R&D pipeline activity

Biopharma Drug Development Gaps Strategy

Mabion photo for Contract Pharma Magazine

Mabion’s Fill & Finish services in Contract Pharma Magazine

Lecanemab to treat Alzheimer's disease

Lecanemab approved by EMA in early Alzheimer’s after re-evaluation

Gastric cancer treatment

Zolbetuximab demonstrates significant benefit in gastric cancer and receives approval in the EU

Lecanemab slows Alzheimer's disease progression.

Lecanemab, a breakthrough Alzheimer’s drug, rejected by EMA