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Smart Biologics Development and Manufacturing, and SMARTag™ Technology: For ADCs, Bioconjugates, and ADVASEPT® Aseptic Filling

Min Park

August 10, 2016

3 Min Read

Catalent-logo_CMYK-300x91.jpgFrom drug and biologic development to delivery technologies and supply solutions, Catalent is the catalyst for your success. With 80+ years of experience, we have the deepest expertise, broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and improved results. Catalent is your strategic partner for biologic drug development and manufacturing success.

SMARTag™ technology offers a new toolkit to optimize antibody–drug conjugates (ADCs) and bioconjugates. It allows site-specific, programmable drug placement using proprietary cytotoxin-linkers and conjugation chemistry in an efficient and scalable process. The result is improved ADC consistency, superior linker stability, and compatibility with any cell-based expression system.

Biomanufacturing Center of Excellence — Increasing Flexibility and Manufacturing Scale for Customized Solutions: Our state-of-the-art biologics manufacturing facility uses single-use systems and offers flexibility and scale to support your growth. We offer a broad range of integrated, process development, and analytical services to solve your most difficult development and biologics manufacturing challenges, including

  • Process development with flexible CGMP (10–1,000L) and nonCGMP (<250 L) experience

  • Colocated analytical laboratory to support method development, in-process, release, and stability testing

  • Tailored process development for any mammalian cell line

  • Solutions for difficult-to-express proteins. Catalent provides expanded GPEx® cell line engineering capacity for biosimilars, integrated development for challenging biologics, and single-use technologies to reduce cross-contamination risks.

GPEx Technology — Proven Development of High-Performance Production Cell Lines: This proprietary technology is based on a pseudotyped, high-performance vector that generates highly stable cell lines in a wide range of mammalian host cells, including CHO-S, CHO-K1, CHO-DG44, HEK293, and CAP. Nearly any cDNA (monoclonal antibodies (MAbs) and multigenic applications) can be packaged into the GPEx retrovector and used to transduce your mammalian cell line. Manufacturing can take place at our Madison, WI, site or efficiently transferred to your facility. GPEx technology offers:

  • Reliability: Productivity is 50–100+ pg/cell/day, final titers to 7 g/L in fed-batch bioreactor systems, stability demonstrated to 100 generations, without need for selectable markers

  • Efficiency: From cDNA to 100s of milligrams of protein from early cell pool, rapid production of a master cell bank, stable pools from the outset; removes stability testing from the critical path

  • Proven Technology: 40% of marketed biosimilar MAbs use GPEx technology; seven products marketed commercially and two in phase 3 trials; 460+ different antibodies/antibody fusions; 50+ different recombinant proteins; 30+ on-going clinical trials; 40+ current clients/80+ active projects.

ADVASEPT ® Advanced Aseptic Liquid Injectable Filling: This technology for parenteral products provides a glass-free, primary packaging solution that reduces and even eliminates some of the most pressing concerns associated with traditional glass vials.

ADVASEPT technology eliminates glass particulates and surface delamination, reduces foreign particulates by orders of magnitude, and decreases protein surface interactions, breakages, and transit weight.

ADVASEPT Vial is proven as a container for biologics. The innovative platform leverages blow-fill-seal and automated stopper insertion to minimize variables and production footprint.

ADVASEPT® Lock is a stopper-less, Luer-locking vial for needleless withdrawal of liquids for safe and efficient administration.

A Broad Range of Integrated Development Services: Catalent Biologics has the unique technologies, deep expertise, and a proven track record of global regulatory and commercialization experience to solve your most difficult programs. Services include formulation development, custom bioassay development/management, pharmacokinetics/pharmacodynamic and immunogenicity, assay qualification, biosafety testing, viral clearance and stability studies, biostructural characterization, and clinical supply and cold chain. Catalent Biologics — smart technologies, tailored solutions, and better treatments. To learn more, visit catalentbiologics.com.

Min Park is at Catalent Pharma Solutions; 1-732-208-6374; [email protected].

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