CDMO SERVICES FOR VIRAL VECTORS & VACCINES

Process Development

Whether you are a biopharmaceutical company, academic research institution, or clinical-stage biotech startup, our process development expertise can accelerate your journey towards developing safe, effective, and commercially viable viral vector-based therapeutics.

IN A NUTSHELL

Expert Process Development for Viral Vectors and Vaccines

We specialize in process development for viral vectors, focusing on lentiviral, AAV, adenoviral vectors, and poxviruses like MVA. Our expertise ensures efficient, scalable production for cell and gene therapy and vaccine development. We guide clients through every stage, from vector design and optimization to upstream/downstream development, purification, and analytical characterization. Utilizing cutting-edge technologies and best practices, we deliver tailored solutions to meet each project's unique needs and regulatory requirements.

SERVICE OVERVIEW

End-to-End Expertise

Vector Design and Optimization

We collaborate closely with our clients to design and engineer viral vectors with enhanced transduction efficiency, specificity, and safety profiles. Our expertise in molecular biology and genetic engineering enables us to optimize vector constructs for maximum therapeutic efficacy. This includes, for instance, our in-house developed DirectedLuck^® transposase system for the stable integration of packaging genes for the development of efficient producer cell lines.

Upstream Process Development (USP)

We employ cutting-edge cell culture technologies and bioprocess optimization strategies to develop scalable and high-yielding production processes. By optimizing parameters, such as cell line selection, media formulation, and bioreactor conditions, we ensure efficient vector production while minimizing production costs and timelines. In the upstream process, we utilize a range of bioreactor systems to facilitate the efficient growth and production of viral vectors. Our capabilities include the use of wave bioreactors, orbital shaken bioreactors, and stirred tank bioreactors, which allows for precise control over key parameters such as pH, temperature, and dissolved oxygen levels. These bioreactors are optimized for scalability and enable seamless transition from small-scale research to large-scale production.

Downstream Process Development (DSP)

Our downstream process development services focus on the purification and concentration of viral vectors to achieve high purity and potency. Filtration is one of the fundamental steps in DSP since it facilitates the removal of cellular debris, host cell proteins, and other impurities while retaining the viral vector particles. Our advanced filtration technologies, including depth filtration and tangential flow filtration (TFF), enable efficient clarification and concentration of the viral vector harvest.

We leverage the ÄKTA pure^TM system, a state-of-the-art chromatography platform, for protein purification and viral vector purification. This system offers high-resolution separation and purification capabilities, allowing for the removal of impurities and contaminants while preserving vector integrity and functionality. Our chromatographic methods, such as affinity chromatography and ion exchange chromatography, selectively capture and separate viral vectors from contaminants to ensure superior product quality and safety.

Analytical Characterization

Quality control and analytical testing are integral components of our process development workflow. We utilize a comprehensive suite of analytical techniques, including ddPCR and qPCR, ELISA, SDS-PAGE, next-generation-sequencing (NGS), and DLS-based particle measurements as well as sophisticated cellular assays, to assess vector integrity, purity, and potency at various stages of development. Detailed information about our comprehensive analytical methods can be found here: Quality Analytics.

Regulatory Support

We understand the complex regulatory landscape surrounding viral vector-based therapeutics and provide comprehensive support to facilitate regulatory submissions and approvals. Our team assists clients in compiling regulatory documentation, conducting risk assessments, and navigating regulatory requirements to ensure compliance with global regulatory agencies.

Infographic Title Placeholder

End-to-End Services

Downstream Process Development

Reliable Downstream Processes and Confirmation for the Purification of Recombinant Proteins.

The development of downstream processes is at the heart of every PBG manufacturing project. By combining different filtration and chromatography techniques, we develop customized processes that are tailor-made for each product. This allows us to ensure the highest possible product purity for our customers while simultaneously maximizing process yield. With over 25 years of experience in protein purification, our expertise covers a wide range of antibody formats (e.g. IgG1, IgG4, bispecific and multispecific antibodies), as well as the production of glycoproteins and multimeric glycoproteins. This enables us to ensure the development of robust and state-of-the-art market processes.

Upstream Process Development

Robust and Efficient Mam Upstream Process Development-1 malianCellProduction Processes for Bioreactors of Varying Scales

Process development for fed-batch and intensified fed-batch cultivation modes for a variety of recombinant protein formats (e.g. IgG, bi- and multi-specific, fusion)
Investigation of perfusion setup at small- and lab-scale (1-5L using ATF® technology or 0.2L to 100L using rocked motion bioreactors, with integrated perfusion membrane)
Focus on product quality, performance, manufacturability and yield
Tech transfer and subsequent process optimization of existing processes
State-of-the-art bioreactor technologies from 15 ml to 250 L scaleState-of-the-art seed train development including N-1 perfusion
Cell harvest platform procedure for max. step yield

Formulation Development

Determination of the Most Suitable Formulation for Your Product Using HTPD (High Throughput Development)

ProBioGen has developed a formulation plate in which the components and pH of various additives in different main buffer systems are tested for the stability of your product in order to find the most suitable conditions for your product. We can offer you process development and formulation development in one company.

We are able to supply a formulation development package in which initially around 90 different formulation conditions are tested, from which the top 3 candidates are taken to the in-house stability study (formulation assessment).