CDMO

Boutique end-to-end CDMO

Serving pharmaceutical, biotech, and alternative protein food tech companies with pilot and clinical process development and manufacturing 

  • Aseptic Filling

  • Upstream process development

  • Downstream process development

  • Process scale-up, upstream and downstream

  • Analytical method development

  • Media and buffer preparations

  • Production for Clinical Phase I/II/III

  • GMP batch manufacturing up to pilot scale

  • Pharmaceutical and biotech companies

  • Alternative protein food tech companies

  • Pilot, clinical and process development stages

Scinai offers comprehensive CDMO services to support:

cGMP Manufacturing

Manufacturing suites include clean rooms for:

  • Upstream fermentation

  • Downstream purification

  • Media and buffer prep

  • Automatic aseptic filling to vials and PFS

  • Labeling and visual inspection

  • Site designed to meet EMA and FDA GMP standards

  • Previously passed European QP (EMA) and Israeli MoH audits for Phase 3 clinical trial product

State-of-the-art laboratories

Technical R&D and QC labs support:

  • Manufacturing process development & scale-up

  • Analytical methods development

  • In process controls and product release testing

Deep Pharma Experience

In-house expertise includes:

  • 20 years of recombinant protein process development from bench to Phase 3

  • cGMP manufacturing from preclinical through Phase 3 clinical trials

  • Startup and big pharma leadership in USA, Israel, Europe, China, and Singapore

  • Proven development and manufacturing success

  • cGMP production

  • Upstream process development and scale-up

  • Downstream process development and scale-up

  • Analytical method development and quality (QA & QC)

  • Aseptic filling

Scinai’s People: Deep & Relevant Capabilities

  • Amir Reichman, CEO

    Senior leadership positions at GSK Vaccines, Belgium; Global pharmaceutical engineering and supply chain leadership, including large capital expenditure projects building vaccines manufacturing sites in Belgium, Italy, Germany, Hungary and USA.

  • Dr. Tamar Ben-Yedidia, CSO

    Co-invented and guided a recombinant protein vaccine candidate through 8 clinical trials including pivotal Phase 3 in 12,000+ participants.

    PhD (Weizmann Institute of Science).

  • Elad Mark, COO

    An executive leader and principal process engineer with over 15 consecutive years of biotechnology industry experience encompassing diverse project stages including feasibility studies, conceptual and detailed design, commissioning, qualification, and process validation.

    Built manufacturing sites for recombinant protein in China and mABs for Novartis Singapore.

  • Dr. Dalit Fischer, CTO

    Previously Director of Biological Processes at NanoSpun Technologies Ltd. and CTO at VAYU Sense AG, specializing in improving bio-based fermentation processes with an AI-based controller. Dalit also led the Natural Biotechnology Systems Department at Sigma Aldrich for eight years.

    PhD Molecular Genetics and Microbiology (Hadassah Medical School, Hebrew University of Jerusalem)

  • Dr. Tehila Sonnenfeld, PhD, Director of Production

    Extensive experience in aseptic production under GMP conditions.

    PhD Biochemistry (Hebrew University of Jerusalem)

  • Dr. Oded Ovadia, Director of Analytical Methods & Preclinical Trials

    Extensive biopharmaceutical R&D industry experience with expertise in analytical development of biosimilar and innovative biomolecules.

    PhD Pharmaceutical Sciences (Hebrew University of Jerusalem)

  • Merav Kamensky, Head of Quality Control

    Experience as a laboratory researcher at the University of Waterloo, Canada and in the biopharmaceutical industry including positions at Abic Biological Laboratories, Teva, and InSight Biopharmaceuticals.

    Led QC chemistry and biochemistry analytical operations at SciVac Therapeutics (VBI.) under cGMP conditions and supported FDA and Israel MoH audits.

  • Zohar Gadri, Technical R&D Upstream Process Team Leader

    Science-based approach with more than 20 years experience with cell culture, fermentation development and optimization processes, from academic research to cGMP Phase 3 production.

    Comprehensive understanding specifically related to fermentation and clarification techniques like inoculation, fermentation, depth filtration, various types of centrifuges and related analytical processes.

  • Barry Cohen, Technical R&D Downstream Process Team Leader

    Science-based approach with more than 15 years experience in protein development, from academic research to cGMP Phase 3 production.

    Comprehensive understanding of downstream production processes in bulk biological manufacturing (bulk drug substance), with proven expertise in purification techniques including chromatography and ultra-filtration processes.

  • Maxim Leykin, Head of Engineering

    Years of engineering project management and maintenance leadership with Omrix, Intel, and SodaStream.

  • Alona Tal, Quality Assurance Senior Manager

  • Dr. Naama Adi Hen, Quality Assurance Senior Manager

  • Navah Figov, Technical R&D Downstream Process Team Leader

    Expertise in downstream process including both developing purification and scale-up processes for GMP pharmaceutical manufacturing.

Tell me more about Scinai’s Boutique CDMO!