The process of bringing life-saving biotherapeutics to market is both time-consuming and complex. With over 35 years of experience, Richter BioLogics is renowned as a premier contract development and manufacturing organisation (CDMO), consistently delivering best-in-class services and maintaining an exceptional reputation within the industry.
Our core area of expertise and competence
Richter BioLogics is keeping pace with the growing demand for operational agility and manufacturing excellence, especially as customer pipelines become more diverse over time and new technologies emerge. In doing so, the company is meeting the needs of modern biopharmaceutical development and manufacturing. Our long experience as a CDMO speaks for itself, with a proven track record of completing over 1,000 successful GMP batches and supplying more than eight commercial products.
Your product is our dedication – let’s succeed together!
Richter BioLogics is a leading microbial CDMO founded in 1987 and headquartered in Hamburg, Germany. Our core expertise lies in the development and manufacturing of biologics using microbial expression systems. For nearly four decades, we have specialised in providing tailored, flexible and scalable solutions for biopharmaceutical companies.
We build on massive experience with countless projects, various microbial platforms and three high-level good manufacturing practice (GMP) facilities. The CDMO services we deliver support early-stage development through to process performance qualification (PPQ) and commercial GMP production for biotech companies and global pharma alike. This allows us to guide your products from gene to final release with high confidence.
Choosing Richter BioLogics is a strategic decision for several reasons. We offer a unique combination of specialised expertise in microbial manufacturing, end-to-end service! integration and a profound commitment to partnership.
Our model minimises risks associated with multiple technology transfers by managing projects from initial cell line development to final product release. This saves clients significant time and cost. Furthermore, our development and production facilities are GMP-certified and approved by major international regulatory bodies. This ensures your product meets global standards with all our sites. Our recent recognition in the CDM market, including winning the 2025 CDMO Leadership Award in the Biologic category in both the US and Europe, highlights our position as an industry leader and demonstrates the excellent partnerships we have with our customers.
Richter BioLogics is a medium-sized microbial CDMO. Our size uniquely enables us to deliver tailored solutions with an agility that many larger organisations may struggle to achieve. We are proud to collaborate with numerous leading big pharma companies, who greatly value and acknowledge our flexibility. Our portfolio also reflects a focus on late-stage and commercial products. Our teams are well experienced in successful PPQ execution to fully fulfil regulatory confidence.
This is the foundation for commercial production, ensuring long-term success and to meet expectations of authorities worldwide for biologics and advanced modalities.
This underscores our expertise and capability in guiding the complexities of advanced development phases and regulatory approvals.
Quality is in our DNA
At Richter BioLogics, quality is a principle integrated into every level of our organisation. This commitment to quality is upheld by our people, our systems and our strategies. All our processes are designed to be audit-ready and compliant with the highest international GMP standards. Our dedicated team of scientists, operators and project managers ensures that every project is executed with unwavering dedication to quality, safeguarding patient lives and supporting global health improvements.
Selecting the right CDMO. Richter BioLogics, your partner of choice
We are a trusted partner for clients with extraordinary experience
With over 35 years of proven excellence, our experience translates directly into client success. We have a deep understanding of the complexities of biopharmaceutical development and manufacturing. An extensive track record of more than 1,000 GMP batches manufactured allows us to anticipate challenges, streamline processes and navigate the regulatory landscape effectively.
Our expertise in microbial systems is particularly beneficial, as we leverage these platforms for their cost-effectiveness, rapid growth and high yields. This knowledge ensures that we guide our clients through every project phase up efficiently, without compromising on quality. We believe that transparency and open communication are the foundations of successful partnerships. Our approach is centred on our ‚Person in Plant‘ philosophy, which emphasises customer-centric thinking and hands-on engagement. From day one, clients gain full visibility into development and manufacturing processes. We integrate your project team with ours, fostering a culture of collaboration where senior executives and technical experts are actively involved. We work with our customers at eye level, ensuring a seamless and supportive journey towards your product’s success. Only a high awareness of the customer’s needs ensures that the services meet the customer’s expectations.
Services and expertise
Richter BioLogics specialises in delivering world-class CDMO services across the whole value chain. Our primary goal is to bring our clients‘ live-saving therapies to market successfully and in a reasonable time to improve the lives and health of people. This is why our offerings are designed to be flexible, and can be tailored into working packages that suit your project’s specific stage and requirements. Our services include:
Complete and tailored development
We can start from the initial gene sequence and manage the entire process through to production and release. This includes strain development, upstream and downstream process development, and process characterisation and analytical development.
Technology transfers
We are experts at transitioning existing client processes into our facilities. We have implemented controlled structures and harmonised procedures across all our sites. This approach is designed to streamline our processes company-wide and allows for straight tech transfers, or process development for maximised yields. This is true from cell line development to commercial manufacturing.
Clinical trial support
Our capacities fit your requirements. We adapt to your needs and provide GMP-compliant materials for all phases of clinical trials.
Performance of PPQ
In preparation to market supply we execute PPQ to verify the process is stable, reproducible and compliant with regulatory requirements. We are experts in PPQ campaigns for many customers of various sizes. With more than 12 years‘ experience in PPQ, we deliver the quality standards needed.
Commercial market supply
Our facilities are equipped for reliable, large-scale and commercial manufacturing. As the portfolio of our client products reflects a remarkable focus on late-stage and commercial products, our expertise and capability in navigating the complexities of advanced development phases and regulatory approvals is underscored.
These core services are supplemented by comprehensive project management and robust regulatory support.
From clinical to commercial production – we deliver fast, scalable and reliable!
Facilities: Richter BioLogics' manufacturing facilities equipped to support every client project
Our commitment to taking our clients needs seriously has led us to implement proactive measures to ensure steady and sustainable growth. To meet growing market demands, we have strategically expanded our production capabilities. Our operations are spread across three production sites, including a new 10,000sqm state-of-the-art multipurpose facility with huge warehouse capacity. The multipurpose facilities possess manufacturing licences for proteins, vaccines and DNA. At Richter BioLogics, we have experience with several production technologies including methanol
feeding for Pichia expression, enzymatic and chemical PEGylation, low-shear cell lysis, and cell attenuation.
Key features of our facilities are:
Flexible production lines
We operate multiple multipurpose production lines of which all are GMP-certified. Fermenter capacities include two 300L and two 1,500L. This allows for seamless scaling from clinical to commercial production. We utilise 100% oxygen aeration technology to support high-cell-density fermentation, maximising product yield. The installed equipment is well suited for biopharma production (eg, preparative high performance liquid chromatography, large refolding vessels).
Advanced analytical labs
‚Knowing your molecule‘ is more than a slogan – it’s our operational discipline. Our QC facilities contain best-in-class equipment. We perform innovative in-house analytical techniques to ensure rigorous quality control throughout the manufacturing process. This also includes bioassays and liquid chromatography-mass spectrometry. We adapt to your programme and implement a targeted analytical panel for identity, content, potency, purity and impurity profiles for each product. We combine deep scientific expertise with an agile operational model to accelerate development, derisk scale-up and ensure regulatory-conform outcomes from day one.
The purpose is to release safe, high quality drug substances with confidence.
Expanded development labs
We have significantly expanded our lab and development areas to support process development (PD), characterisation and optimisation activities. The PD department ensures that the transition from scratch to batch is swift and smooth.
Our highly skilled PD teams support your projects with fermentation development (E coli, Corynex*, yeast, cell-free systems and others) and is also equipped for biosafety level 2 work.
These capabilities ensure we can deliver fast, scalable and reliable manufacturing solutions as needed.
We ensure a seamless transition from clinical to commercial manufacturing
We ensure a seamless transition by design. Our implementation of controlled, harmonised processes across our sites minimises variability and friction during scale-up.
The availability of multiple production scales (300L and 1,500L) allows projects to transition smoothly from smaller clinical batches to larger commercial volumes within the same quality system and operational framework. This approach avoids the common pitfalls of major technology transfers between different vendors or sites, ensuring consistency and efficiency.
The molecules and products we specialise in
Our competences are microbial expression systems. They offer cost-effectiveness, are robust, grow fast and provide high yields for certain products. Our specialisation is in microbial expression systems like E coli and Pichia pastoris (Komagataella phaffii). We leverage these systems for their robustness, cost effectiveness and rapid development timelines, which are often advantageous compared to mammalian systems. Our expertise extends to integrating cutting-edge technologies to broaden our capabilities. This includes the Corynex® system, a Gram-positive bacterial platform, and cell-free protein synthesis (CFPS), which offers an alternative route for producing certain proteins.
For plasmid DNA (pDNA) production, Richter BioLogics specifically designed an advanced, in-house process called pART platform process. The primary benefits of the pART platform are its ability to deliver consistently high yields and exceptional purity. It works with almost any plasmid construct.
We have a strong track record with a variety of complex molecules. The broad product portfolio includes:
- Recombinant proteins and peptides: this is a core competency, representing over 60% of the biologics we produce. They include secreted, periplasmic and insoluble proteins. Molecules include peptides, enzymes, cytokines, scaffolds, fragment antigen-binding, single-chain variable fragment, single-domain antibodies, antibodies, variable heavy domain of heavy chain (VHH)/nanobodies and more
- Antibody-like molecules: we are pioneers in the production of molecules like VHH/nanobodies. Here, we built on our experience with several client projects and developed an easy-to-adapt process development toolbox
- Bacterial vaccines: we have extensive experience in developing and manufacturing various bacterial vaccine types (eg, live, attenuated vaccines, inactivated vaccines) and of different bacterial strains
- pDNA: we offer an excellent platform process called pART for high-yield, high-purity pDNA delivered in short timelines. This platform is versatile, supporting the production of both cGMP material and other quality-grade pDNA. The pDNA is suitable as an active pharmaceutical ingredient or as a starting material for cell and gene therapies and mRNA vaccines.
Over the years, Richter BioLogics established generic procedures and implemented analytical testing methods and proprietary production processes in-house. This guarantees our clients the best possible outcome for their product, time-savings and cost-effectiveness. This deep-rooted expertise, also with complex and hard-to-manufacture products, positions us as a preferred partner for biologics well suited for microbial production.
Richter BioLogics' global regulatory compliance record
Our commitment to quality is validated by our extensive regulatory credentials. Our GMP-certified facilities have been successfully inspected and approved by key global regulatory bodies. These include, but are not limited to:
- US Food and Drug Administration
- European Medicines Agency
- Japan’s Pharmaceuticals and Medical Devices Agency
- Brazil’s National Health Surveillance Agency
- Health Canada
- South Korea’s Ministry of Food and Drug Safety.
This widespread regulatory acceptance provides our clients with the assurance that their product will meet the stringent requirements of multiple major markets, all from a single manufacturing partner.
The customer in focus
Being customer-centric means we place our clients‘ product success at the heart of everything we do. We understand that choosing a CDMO is about finding a true partner. Our customer-centric approach manifests in several ways:
- Tailored solutions: we do not offer one-size-fits-all services. We work with our clients to create customised working packages that align with the project’s specific needs and goals
- Flexibility: we design our services to be flexible, allowing us to adapt to evolving project needs and accelerate timelines whenever possible
- We can provide fast-tracked projects: A recent project highlights our ability to execute complex projects with speed and precision. A client required a nanobody product for clinical trials under an aggressive timeline.
By implementing an innovative and highly efficient platform process, our team delivered GMP-compliant material within just six months from the initial cell bank production. This achievement demonstrates our commitment to meeting critical client milestones while upholding the highest standards of quality and regulatory compliance
- Proactive communication: we maintain clear and open lines of communication via experienced project managers. They are dedicated to individual projects and ensure clients are informed and involved at every stage
- Unwavering support: our teams provide dedicated support, and clients have access to experts across various departments. Senior leadership is actively engaged in client projects.
Ultimately, our goal is to function as an extension of your own team, working collaboratively to bring your life-saving therapy to market. Our strong industry reputation as a leader in microbial biologics manufacturing allows us to attract top-tier talent. We provide these highly motivated professionals with a healthy, dynamic and inspiring workplace that encourages innovation and excellence. By investing in our people and fostering a collaborative environment, we ensure that the most skilled and dedicated experts are working to advance your products effectively. This commitment to talent is a core component of our promise to deliver superior outcomes for our partners.