Enhance Your Research With Biologics Contract Manufacturing & Production Services

Seamlessly transition your biologics from preclinical formulation development to commercial product release with our biologics manufacturing and production services. Our trusted and individualized approach transforms your biologic from an innovative concept to an impactful reality while maintaining CGMP guidelines. Collaborate with our dedicated team of scientists, committed to upholding the quality, consistency, and integrity of your cell and viral banks.

Realize the full potential of your research with our precision antibody, protein, and vaccine manufacturing capabilities.

 

Cell Banking

Explore our comprehensive range of cell banking services. From Master Cell Banks (MCBs) to Working Cell Banks (WCBs), Research Cell Banks (RCBs), and End-of-Production Cell Banks (EoPCBs), our facilities ensure top-quality, compliant, and reliable cell line preservation.

 

Antisera Production

Select from monoclonal and polyclonal antisera production with customized immunization protocols. Our range includes SPF rodents to large animals, ensuring CGMP-compliant services tailored for your specific needs.

 

Monoclonal Antibody Production

We now offer contract monoclonal antibody production services including bispecific antibodies and Fc-fusion proteins through our partnership with Wheeler Bio offering the benefits of their Portable CMC® platform to all our customers.

 

Vaccine Manufacturing

Accelerate your vaccine development projects with the help of our CGMP-compliant biologics contract manufacturing capabilities. Benefit from our over 20 years of vaccine manufacturing experience to carry your vaccine into commercialization.

 

Fast-track your cell and gene therapy project with comprehensive services

Our streamlined approach to biologics contract manufacturing blends a shared quality system with rapid internal technical transfer and team collaboration to bypass program bottlenecks. Experience our synergized workflow and enjoy a seamless experience to help propel your cell and gene therapy research from discovery to commercialization.

Together, our team has supported the development of 10 FDA-approved cell and gene therapies and, in the past year, has conducted over 900 studies in the field.

Harness the power of cell and gene therapy with our multidisciplinary panel of experts. Explore our wide range of biologics manufacturing services and realize the full potential of your research. With our extensive scientific and regulatory background, we’ll guide you at every step of your journey and foster collaborative problem-solving along the way.

Plasmid DNA Manufacturing Services

Customize your plasmids and perform cell and gene therapy research at any scale without compromising quality.

Custom Cloning

Streamline your research with our simple three-step custom cloning process.

Viral Vector Manufacturing

Transform your viral vector research into a patient-ready product with flexible scalability and ease.

Viral Vector Packaging Services

Breach new frontiers in viral vector-based gene therapy research with our dedicated team of AAV and lentivirus packaging specialists.

Cell Therapy Manufacturing Services

Swiftly scale up your cell production while meeting CGMP guidelines.

Plasmid and Viral Vector Products

Leverage our innovative biologics manufacturing processes and enhance your gene discovery programs.

Learn More About our CDMO Solutions

Harness the Charles River advantage to conduct high-quality biologics manufacturing

Discover the Charles River Laboratories advantage, where decades of experience and capabilities converge to drive your project forward.

  • Expertise and Capabilities: With industry-leading expertise and state-of-the-art technologies we can support every stage of your biologics manufacturing journey.
  • Maximize Resources: Our streamlined manufacturing process allows you to efficiently scale up your biologics production.
  • Fast Time to Market: With our ready-to-go and cutting-edge biologics manufacturing equipment, you can accelerate your product's journey to market.
  • Reduced Risk: Our biologics contract manufacturing services ensure CGMP-compliance of your pharmaceuticals. Every step in our process is fortified by rigorous quality control measures, guaranteeing unparalleled product excellence.
  • Communication and Collaboration: Our dedicated team of experts, who prioritize clear communication and in-depth teamwork, is ready to collaborate closely with you.

Speak with a Biologics Manufacturing Expert

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Expert Roundtable: Lentiviral Vector Manufacturing
This roundtable discussion draws together acknowledged experts from the fields of LVV design, manufacture, and regulation to examine the key current trends in the space and point the way to future success.
Watch On Demand

Frequently Asked Questions (FAQs) About Biologics Contract Manufacturing

  • What are some key considerations when selecting a CDMO?

    Choosing the right Contract Development Manufacturing Organization (CDMO) involves a careful balance of quality, cost, capacity, timeliness, location, technology, expertise, and good communication. Ultimately, the best CDMO for your project will depend on your project goals, so it is important to carefully consider each of the above criteria to ensure your needs are met throughout the entire process.

  • What types of biologics does Charles River produce?

    Most CDMOs have the tools and expertise to produce a wide range of biologics for different therapeutic and research purposes. At Charles River Laboratories, our driven team of specialists is dedicated to assisting your biologics manufacturing endeavors. From high-quality antibodies to recombinant proteins, vaccines, viral vectors, custom DNA constructs, therapeutic oligonucleotides, and modified cells, join us as we expand the horizons of biomedical research and explore unprecedented opportunities.

  • What are some challenges of biologics contract manufacturing?

    Unlike traditional pharmaceutical manufacturing, which typically involves the chemical synthesis of small-molecule drugs , biologics manufacturing exploits the sophisticated biological processes of living organisms to produce large and intricate macromolecules. This is complicated by the use of different cell types and organisms, whose growth and production require maintenance under precisely controlled conditions. Moreover, the sensitivity of biologics to manipulation and conditions like pH and temperature make it challenging to maintain their purity and quality throughout the manufacturing and storage process. Finally, the layers of complexity associated with biological processes also impart challenges of scalability, which can delay commercialization.

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