Company News

ProJect Pharmaceutics is excited to open newly expanded lab space, now home to our most recent acquisition: the Orbitrap Exploris 240 LC-MS – a cutting edge, high-resolution platform capturing complex molecular insights and delivering deeper analytical clarity for complex formulation challenges. Curious what next-level analytics can do for your project?

The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has started to gain increased interest and applications in the biopharmaceutical industry. MAM can, by applying only one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection (Yang et al., Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control, MABS 2023, Vol. 15, No. 1, 2197668). These days, LC-MS is rapidly emerging as a preferred technology for Multiple-Attribute Analysis (MAA), especially for complex biologics. By consolidating into a single, information-rich run what previously required multiple chromatographic methods (RP, IEX, HIC, R-CE-SDS, etc.), LC-MS provides detailed molecular insights, enabling monitoring of critical quality attributes of complex therapeutic proteins. Several literatures (i.a. Rathore et al., The role of mass spectrometry in the characterization of biologic protein products, Expert Rev Proteomics, 2018, 15(5), 431-49) have divided the role of MS in the characterization of biologics into the following main areas: product identity testing, characterization, comparability assessment, adulteration analysis, demonstration of critical quality attribute consistency during product development, and in PK/PD studies. A trend today, a potential regulatory standard for quality control (QC) testing tomorrow? ProJect Pharmaceutics is already leading the way with next-generation technology on board!

ProJect Pharmaceutics is a CRO specialized in formulation and lyophilization process development for injectable drug products. Our newest team member, the Orbitrap Exploris 240 LC-MS (by Thermo Fisher), has moved into our expanded laboratory space, enabling next-level analytics for formulation and process development of injectable drug products, such as:

• mAb and ADC characterization
• Native DAR determination by SEC-MS
• Drug-load-distribution by PepMap
• Detection of degradation (fragments, side chain modifications, hydrolysis)
• Analysis of mAb glycosylation
• Impurity analysis (e.g. HCP)

Partner with us to unlock faster, deeper, and more precise analytical insights.

Since 2010, ProJect Pharmaceutics CRO has stood for high-level formulation and process development for injectable parenterals. Today, we proudly look back on 15 successful years. We are truly grateful to our dedicated team, valued clients, and trusted partners who have been part of this journey. 

A sincere thank you to our partners and customers for your continued trust, loyalty, and collaboration. We are thrilled to reaching many more milestones together!

Munich, Germany, September 11, 2025 / — As a leading specialist in the formulation and process development of biologics and complex small molecules—particularly antibody-drug conjugates (ADCs) and virus-based therapeutics—the company ProJect Pharmaceutics views this collaboration as a significant step in accelerating its expansion. Founders Dr. Andreas Schütz and Mr. Klaus Hellerbrand will remain substantial co-investors and continue to serve as managing directors.

Renowned for its deep scientific expertise and proprietary know-how in pioneering biologic therapeutics such as ADCs, ProJect Pharmaceutics has a proven track record of overcoming critical challenges in formulation and lyophilization process development using cutting-edge technologies. Long-standing partnerships with global biopharma and innovative biotechnology companies underscore the company’s unique position in the biopharma services landscape.

Well positioned for substantial growth opportunities, ProJect Pharmaceutics aims to expand its international customer base, leverage its expertise to broaden service offerings into adjacent areas, and pursue external growth opportunities. The company’s overarching goal remains to strengthen its leadership as a specialized innovation partner in biologics formulation and development.

The decision to partner with Afinum reflects ProJect Pharmaceutics’s commitment to preserving the entrepreneurial culture and scientific excellence that have defined the company since its founding in 2010 in Martinsried near Munich, Germany. Afinum’s experience in the healthcare sector and its history of successful investments in founder-led companies provide a strong foundation for executing an ambitious growth strategy. Future initiatives will focus on expanding ProJect Pharmaceutics’ global commercial footprint, diversifying its offerings, and investing in organizational development through targeted acquisitions.

This new chapter is expected to further reinforce ProJect Pharmaceutics’ position in the biologics market and drive innovation through strategic collaboration.

About ProJect Pharmaceutics GmbH

ProJect Pharmaceutics is one of the leading European service providers offering tailored pharmaceutical formulations and lyophilization processes for therapeutic proteins, peptides and other therapeutic compounds.

About Afinum Management GmbH

Since its founding in 2000, Afinum has been one of the leading private equity firms for medium-sized companies in the German-speaking region. With offices in Munich, Frankfurt, and Zurich, Afinum combines deep market knowledge in the DACH region with an international investor perspective and specializes in succession and growth investments within four technology-driven future verticals. Afinum partners with successful entrepreneurs to develop uniquely positioned companies to their full potential based on a trustful partnership approach. Autonomy and preservation of corporate culture and identity are of unique importance. This transaction marks the eleventh platform investment of the Afinum 9 fund and the second thematic investment in the Biopharma Services sector.

ProJect Pharmaceutics has extended its capabilities to conduct in-use stability studies. The current portfolio on in-use stability services was topped by the addition of several perfusor pumps, as well as the operation of a red-light laboratory (to handle light-sensitive substances). We have the necessary laboratories, technical equipment, consumables and expertise to replicate the conditions for a clinical trial so that the stability of a drug can be evaluated in real-life application scenarios. This enables us to conduct in-use stability studies for injectable drug products from as early as during formulation development to as late as ahead of clinical trials.

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. Expanding the offering of its service portfolio towards the French customer base, ProJect Pharmaceutics was engaged to apply at the French Ministère de L’Enseignement Supérieur, De La Recherche Et De L’Innovation for eligibility to join the French tax credit for research program (Credit d’Impôt Recherche, CIR). After successful approval for the previous years, we are proud to have again received the renewal of CIR application through 2025. We are delighted to continue to offer such big benefit to our French customers once they enter into a collaboration with ProJect Pharmaceutics.

ProJect Pharmaceutics was granted a US patent on a novel formulation which effectively stabilizes the anti-cancer drug Bendamustine and other N-mustard cancer drugs like Chlorambucil, Melphalan, Melflufen, etc. in liquid state at room temperature for up to 24 months.

LIQUID PHARMACEUTICAL FORMULATION
US-Patent No: 11,752,135
US-Application No: 17/042,795

Contact us for:
– Details of the formulation and stability data under various conditions
– Technical assistance to ensure further development and GMP manufacturing

Are you looking for a CRO that quantifies the excipients in your formulation? Particularly for high concentrated protein formulations, a deep understanding of the Donnan effect in your specific formulation is of significant importance. We at ProJect Pharmaceutics have at your disposal the expertise, as well as state-of-the art chromatographic and spectroscopic analysis methods, for quantifying a wide range of excipients. Whether it´s to determine excipient concentrations in the final manufactured drug product or for in-process control measurements, we can quantify the following excipients: Sugars and sugar alcohols, all amino acids, detergents, buffer substances, antioxidants (reduced and oxidized forms), inorganic components. This service is made available to all our clients from now on as part of a project.

ProJect Pharmaceutics is a contract research and development organization (CRO) specialized in formulation and process development for parenteral drug products. To support our client base and next generation customers alongside their formulation development needs, the company does posts on LinkedIn on a regular basis highlighting i.e. common problems we solve for our clients, tips and tricks to overcome formulation challenges, new service offerings, general news to the company, success stories and case studies. You are invited to join our community. We would love to welcome you following the company on LinkedIn.

Do you know the molar extinction coefficient of your (biologics) drug product? According to ICHQ6 the molar extinction coefficient needs to be experimentally determined for drug products. Here at ProJect Pharmaceutics, we are able to determine the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass. This service is made available to all our clients from now on as part of a project.

ProJect Pharmaceutics is proud to have contributed with its services, expertise and knowledge to develop a lyophilized i.v. injection formulation for one of its clients’ drug products which was approved by the U.S. Food and Drug Administration (FDA). Goal of the development was to move from an oral administration of the drug to an injectable one, for patients that are temporarily unable to take oral therapy thus enabling non-interruption of those patients’ therapy with the respective drug product. We congratulate our client by heart for this important achievement.