Modalities & Services
Comprehensive Solutions for Advanced Therapy Medical Products
As a leading biopharmaceutical CDMO, Recipharm Advanced Bio specializes in developing and manufacturing advanced therapy medical products (ATMPs). We offer a wide range of capabilities, services, and modality expertise to meet our clients’ diverse needs. Our integrated approach ensures seamless progression from early development through commercial production, delivering high-quality, scalable solutions for complex biologics.
Supporting the Diverse Advanced Therapy Pipeline
Recipharm Advanced Bio is equipped to handle a variety of advanced therapy modalities, each supported by specialized expertise and state-of-the-art facilities.
xRNA Therapies
Our xRNA therapy capabilities encompass the development and manufacturing of various RNA-based treatments, including:
Efficient production processes for prophylactic and therapeutic vaccines
Precision manufacturing for applications such as protein replacement and cancer immunotherapy
Advanced solutions for RNA constructs capable of self-replication, enhancing therapeutic efficacy
Expertise in producing stable, circular RNA molecules for innovative therapeutic approaches
Through our partnership with Hongene Biotech integrating Hongene’s cutting-edge sgRNA synthesis technology with Recipharm Advanced Bio’s comprehensive manufacturing services, we provide next generation production of guide RNA for gene editing applications
Our end-to-end xRNA services include plasmid and lipid nanoparticle manufacturing, ensuring high-purity RNA products tailored to your therapeutic’s needs.
Viruses & viral vector therapies
We offer extensive experience in the development and manufacturing of viral-based therapies, including:
Production of viral vectors for gene delivery applications
Manufacturing of viruses engineered to target and destroy cancer cells selectively
Development of vaccines utilizing viral vectors to elicit robust immune responses
Our viral vector services are designed to meet the complex requirements of these advanced therapies, ensuring safety, efficacy, and regulatory compliance.
Microbial products
Recipharm Advanced Bio is at the forefront of microbiome-based therapeutic development, offering:
Expertise in cultivating and formulating derived bacteria for therapeutic use
History of monoseptic processes for single-organism injectable bacteria products
Our capabilities in bacterial and microbiome therapies support the development of innovative treatments targeting infectious and chronic diseases, as well as various other health conditions.
Recombinant protein vaccines
Recipharm Advanced Bio, renowned for its expertise in cell culture and downstream purification of recombinant protein vaccines, is the trusted manufacturing partner for multiple non-profit organizations.
Upstream and downstream process optimization for mammalian, insect, and microbial processes
Flexible batch sizes and rapid response
Our recombinant protein vaccine expertise is supporting the advancement of human health around the world.
Comprehensive Program Support
To support the development and commercialization of advanced therapies, Recipharm Advanced Bio offers a comprehensive suite of services tailored to your project’s needs.
Drug Product & Process Development
Recipharm Advanced Bio offers industry-leading process development services to support global clients across all clinical phases and regulatory environments. Our comprehensive development services encompass process and formulation development, ensuring a seamless transition from laboratory to market.
Process Development
Our approach to process development focuses on optimizing scale, productivity, product profile, and cost efficiency for your biologic project. With deep scientific expertise and decades of experience, our team collaborates with clients to design tailored, phase-appropriate strategies that accelerate development and streamline regulatory pathways. Our laboratories are equipped for high-throughput univariate, multivariate, and design-of-experiment (DoE) studies, enabling robust process optimization while ensuring scalability to GMP manufacturing.
Our systematic methodology ensures that each process is reliable, scalable, and tailored to meet the specific needs of your ATMP project. We prioritize robust process development to facilitate efficient manufacturing and regulatory approval.
Key services include:
Systematic development of cell culture and fermentation processes to maximize yield and product quality
Efficient purification strategies to ensure high purity and recovery of the biologic product
Comprehensive studies including process parameter failure modes and effect analysis, scale-down model qualification, and definition of critical process parameters
Phase-appropriate tech transfer services to ensure smooth transition from development to manufacturing
Drug Product Development
Our specialized drug product development services are designed to create stable and effective products suitable for clinical and commercial use. We focus on developing processes that maintain the integrity and efficacy of the payload throughout its shelf life and administration.
Our drug product development team works closely with clients to tailor solutions that meet each biologic product’s unique requirements. This ensures the product’s successful progression from clinical development to commercialization.
Services include:
Identifying optimal formulation conditions to enhance product stability and performance
Developing freeze-drying processes for products requiring enhanced stability
Conducting rigorous stability testing under various conditions to ensure product robustness
Creating and validating analytical methods to assess product quality and potency accurately
Advanced Therapies Manufacturing
Recipharm Advanced Bio provides advanced therapeutic GMP manufacturing services from our multi-product facilities, which feature state-of-the-art equipment for animal cell-derived viral and microbial products.
Our manufacturing capabilities support various biologic modalities, including:
Our focus on process robustness and consistency ensures product quality, purity, and efficacy throughout manufacturing.
Sterile Fill-Finish
We offer comprehensive sterile fill and finish services to meet your advanced therapy product manufacturing needs.
Our state-of-the-art facilities and experienced team ensure the highest standards of sterility and quality for your products.
Services include:
High-capacity, high-speed filling lines can handle various batch sizes
Advanced freeze-drying capabilities to enhance product stability
Quality Systems & Compliance
Recipharm Advanced Bio has a long history of delivering regulatory excellence for customers worldwide. We manufacture in accordance with stringent cGMP standards, and our facilities are routinely audited by agencies worldwide, ensuring the highest level of regulatory compliance. Additionally, our expert team provides CMC guidance, helping clients navigate regulatory pathways, optimize process scalability, and accelerate market entry. Honesty and transparency are at the core of our values, ensuring open communication, risk mitigation, and proactive regulatory alignment as your program progresses.
Smart and efficient regulatory CMC strategies for each unique program
Expert regulatory writing and submission support to ensure compliance, streamline approval processes, and facilitate successful IND filings
Open book access to records, data, SOPs, and reference biological product (RBP)-generated documents
Veeva quality management system and robust digital quality management
Analytical Services
Robust analytical capabilities are fundamental to the success of any biologic program. Recipharm Advanced Bio offers a comprehensive suite of in-house and outsourced analytical services that support every stage of development and manufacturing—from raw materials through final product release. Our assays are phase-appropriate, regulatory-aligned, and designed to ensure identity, purity, potency, safety, and stability across a wide range of modalities.
Advanced Therapies Development & Manufacturing Resources
Advancing Your Program Together
Your program isn’t just another project—it’s a breakthrough in the making. At Recipharm Advanced Bio, we bring deep scientific expertise, innovative thinking, and a problem-solving mindset to every partnership. Whether scaling a complex process, navigating regulatory pathways, or optimizing for commercial success, we’re here to collaborate, adapt, and deliver with excellence.
Let’s push the boundaries of possibility together and bring transformative therapies to patients faster.