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Biologics CDMO Partner

Mabion S.A. and Celon Pharma S.A. plan to initiate collaboration in the development of ADC products

Mabion and SyVento plan to begin cooperation in the field of on aseptic fill and finish of drug products

Mabion secured bridge financing after Q3 2025 and targets break-even by the end of 2026

The new Management Board of Mabion presents the Strategy for 2025–2030

Leading european biologics CDMO Mabion, releases first batch of Novalgen’s next-generation T-cell engager, NVG-222 for first in-human clinical trials

Mabion and WPD Pharmaceuticals Initiate Collaboration on Analytical Method Development for WPD-401

Sartorius and Mabion announce strategic cooperation to advance biopharmaceutical development

Mabion to fulfill CDMO orders for a new client – IBMP

Mabion’s high cost discipline and intensification of business development activities in 3Q 2024

Changes in the composition of Mabion S.A.’s Board of Directors.

Mabion’s solid results and balance sheet in Q2’24, first CDMO orders signed and readiness to acquire more

Mabion will complete CDMO orders worth about PLN 5.5 million for a new UK client

Mabion expands collaboration with Novavax to include analytical work for new product – combined influenza vaccine and COVID

Growing pipeline of submitted bids and another period of solid results and operating cash flow for Mabion in Q1 2024

Very good results and successful implementation of Mabion Strategy in 2023

Nigel Stapleton to support Mabion’s sales growth in role of Business Development Director for Europe

Marty Henehan will strengthen Mabion’s sales operations as Vice President of Business Development for North America

Mabion presents ESG Strategy for 2024-2027

Following a very good period of Q1–Q3, Mabion raises expectations for the full year results in 2023

Changes in the composition of the Management Board of Mabion S.A.

Third consecutive quarter of very strong results,high profitability and consistent transformation towards CDMO

Mabion with agreement to buy new bioreactors, diversifies technology and opens to new customers

Mabion with a quarter of record results. Implementation of activities announced in the Strategy

Mabion announces Strategy for 2023-2027 and summarizes very good Q4 and full year 2022

Mabion expands collaboration with Novavax for vaccine antigen for COVID-19 variant Omicron

Mabion with tenth order under Novavax partnership

Mabion has received ODD status from the FDA for the drug MabionCD20 in the indication of autoimmune hemolytic anemia

Mabion has signed a loan agreement with the EBRD for $15 million (about PLN 66 million)

Mabion has secured approval from the FDA to designate MabionCD20 as an orphan drug for the indication of membranous nephropathy

Mabion’s Article about RFP process named one of the Top 10 Industry Insights of 2025 by Outsourced Pharma

As biologics continue to demonstrate their versatility across the pharma landscape, biotechs are looking for capable CDMOs that can bring these therapies to market to provide innovative treatment to patients with chronic diseases. Amid the vast discussion around how best to assess a CDMO’s offerings and determine whether they are equipped to fulfill a drug program’s needs, the importance of optimizing the request for proposal (RFP) is often omitted. Generally, an RFP describes the immediate needs of the proposed project, the services needed from the CDMO, projected timeline, and budget, all of which is used by a CDMO to generate a cost proposal for services to be rendered. Depending on the needs and knowledge of the sponsor, it might also detail specific technologies and key data points to be procured.

Declaration of the objectives and scope of the European Biotech Act

The European Commission has announced the European Biotech Act, a major policy initiative aimed at strengthening the EU’s competitiveness in health biotechnology and biopharmaceutical innovation. The move responds to a growing gap between Europe’s strong scientific base and its weaker industrial and financial performance in biotech. Health biotechnology employs more than 900,000 people in the EU, around 75% of them in the health sector, and contributes close to €40 billion annually to the European economy. Despite this, the EU attracts only about 7% of global venture capital investment in health biotech, while its share of global commercial clinical trials has declined from 22% to 12% over the past decade. The Biotech Act is designed to address these challenges by reducing regulatory complexity, accelerating development timelines, and improving access to investment capital for biotech companies operating in Europe.

AI Comes of Age in Biologic Drug Discovery

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, such as stability, specificity, and manufacturability. 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 biopharmaceutical innovation will unfold.

Mabion’s Tech Transfer Team wins Biologics CDMO Excellence Europe 2025

We are incredibly proud to share that Mabion has been named Tech Transfer Team of the Year at the Biologics CDMO Excellence Europe 2025 Awards! This recognition is especially meaningful because it comes directly from our industry peers.

Mabion named finalist in four categories at the Life Science Sales & Marketing Awards 2025

Mabion’s marketing and scientific excellence earned four finalist spots at the Life Science Sales and Marketing Awards 2025. We’re proud to announce Mabion’s selection as a finalist. The “Unlocking the Future of Therapeutics” contest leads the way in Campaign of the Year. Individual honours go to Paulina Toboła for Support Professional of the Year. In addition, Jakub Knurek is also shortlisted for Marketing Professional of the Year and the One to Watch Award.

Mabion Awards €500,000 CDMO Services to WPD Pharmaceuticals for Breakthrough ADC Project

Mabion announced today that WPD Pharmaceuticals has been selected by the expert jury as the winner of its “Unlocking the Future of Therapeutics” innovation contest. WPD Pharmaceuticals will receive up to €500,000 in service credits for Mabion’s biologics development and manufacturing services with which it can accelerate the development of the next-generation antibody-drug conjugate (ADC) program in oncology.

They understood how the immune system is kept in check: The 2025 Nobel prize in physiology or medicine

This year’s Nobel prize in physiology or medicine was awarded to researchers who discovered regulatory T cells (Tregs), whose role is to suppress the excessive immune response. Their discovery paves the way for innovative therapies, including antibody-drug conjugates that modulate the activity of immune system to fight cancer.

Mabion is a Biologics CDMO Leadership Award Europe Finalist

Mabion has been honored as a 2025 CDMO Leadership Awards Europe winner in the Biologics category, marking a significant recognition of our scientific and operational excellence. This year’s edition of the awards represents the first European celebration of CDMO achievement, hosted at CPHI Frankfurt.

Jakub Knurek became a finalist of the CPHI Pharma Awards in the Future Leader category

Jakub Knurek, a Marketing Specialist at Mabion S.A., has been named a finalist in the Future Leader category of the CPHI Pharma Awards 2025, to be awarded at CPHI Frankfurt on 28 October. The award recognizes rising talents in pharma, biopharma, academia, or research settings, with at least five years of relevant experience and a maximum age of 35 by the ceremony date.

Mabion Participates in Groundbreaking Clinical Trial of Self-Regulating Immunotherapy

The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA).

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

For the first time in history, the FDA has granted an exemption from the requirement to conduct Clinical Efficacy Studies of biosimilar drugs containing monoclonal antibodies, signaling a fundamental shift toward evidence-based approval pathways. This exemption underscores the growing confidence in a regulatory approach based on high quality scientific research, recognizing that robust comparative data can sufficiently demonstrate biosimilarity. The removal of the requirement for Clinical Efficacy Studies represents a historic milestone for the biopharmaceutical sector, reducing the duplication of clinical knowledge already established for reference products.

Biologics CDMO Market – Mabion Approach to Establishing Cooperation

The CDMO industry for biologics continues to grow, offering complex solutions for the biopharmaceutical industry. Mabion’s winning formula? You will find the answer in a conversation between Nigel Stapleton and Marty Henehan.

Reprogramming Cancer Cells: A New Paradigm in Colon Cancer Reversion Therapy

Cancer Reversion Therapy is groundbreaking new strategy instead aims to reprogram tumor cells back into normal cells, potentially overcoming drug resistance and side effects associated with cell-killing therapies. Research demonstrates that inhibiting a few key genetic “switches” can induce malignant colon cells to differentiate into benign intestinal cells, effectively reversing their cancerous state.

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

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.

Melanoma Immunotherapy Enhance by Immunity Activation

By reintroducing the Interleukin-4 into IFN-I–dominant, inflammation-deficient tumors, scientists successfully reinvigorated T cell–driven tumor rejection. Whether introduced directly or delivered via engineered T cells in ACT, IL-4 helped reshape the immune landscape, boosting effector T cells and improving survival in mouse models.

Single-Dose Monoclonal Antibody Therapy Offers Durable Protection Against Malaria

Monoclonal antibody CIS43LS reduced the cumulative incidence of infection by 87.4% at 40 mg/kg during the 6-month qRT-PCR monitoring period. This Phase 2 trial evaluated its efficacy in 330 adults in Mali during a 6-month high-transmission season.CIS43LS is a human IgG1 monoclonal antibody targeting the circumsporozoite protein of Plasmodium falciparum, designed to confer long-acting protection with a single intravenous dose.