Boutique end-to-end CDMO

BiondVax is pleased to offer our cGMP manufacturing facility, aseptic fill and finish suite, laboratories and experienced professionals for your CDMO services:

  • 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

BiondVax offers comprehensive CDMO services to support:

  • Pharmaceutical and biotech companies

  • Alternative protein food tech companies

  • Pilot, clinical and process development stages

GMP ready Manufacturing Suites

Our manufacturing suites include:

  • Clean rooms for upstream, downstream and aseptic fill and finish

  • Meet international GMP standards: Passed European QP (EMA) and Israeli MoH audits, including fill & finish, for Phase 3 clinical trial product

    DETAILS >

State-of-the-art Laboratories

Our Technical R&D and QC labs support:

  • Manufacturing process development & scale-up

  • Analytical methods development

  • In process controls and product release testing

    DETAILS >

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

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

  • Decades of accumulated knowledge in process development, analytical method development, QA and QC, targeting commercial scale economics and viability

    DETAILS >

BiondVax’s assets for your CDMO needs include:

  • GMP-ready production clean rooms (EMA and Israel MoH)

  • Aseptic fill and finish for clinical trials and pilot scale manufacturing

  • Ambr® 250, 2L and 5L fermentors for upstream process development & optimization

  • 30L and 300L fermentors for upstream GMP production

  • Downstream GMP production: Akta Process, BPG columns, Single Use Mixer

  • Analytic tools

  • Water for injection (WFI)

  • Media and buffer preparations

 

Aseptic Fill & Finish

  • Class B clean room divided with separate sterile entrance for high sterility activities

  • Pre-filled syringe (PFS) Filling & Stoppering Machine for filling injectable in syringes and plunger inserter

  • Sterile filling machine under class A conditions

  • Filling machine capacity of 2,400-3,600 units/hour

  • Passed European QP (EMA) audit

Formulation

Grade C clean rooms

Formulation process in Single Use Systems

Equipment Units Includes:

  • UF Akta ReadyFlux

  • Floor scale

  • Storage containers

  • Glycol cooling TCU

Passed European QP (EMA) audits

Upstream & Innoculation

Inoculation room contains biological hood and shaker incubator.

Highly equipped upstream room suitable for fermentation, harvest and crude IB’s extraction including chilled water, TCU, WFI POU’s

Equipment units include:

  • 300L single use fermentor suitable for bacteria, yeast, and fungal growth

  • Bucket and Disc bowl centrifuges

  • High pressure homogenizer

  • 650L single use mixers custom made BPC optimized for upstream continuous activities

  • Automated CIP skid designed to clean centrifuge and homogenizer

  • Storage containers

Passed European QP (EMA) audits

Downstream

Grade C clean rooms

Designed for continuous purification process, and with easy access to solutions storage

Equipment:

  • Akta Pilot and Akta Process

  • 2 Units 45cm BPG columns

  • Single Use Mixers – 650L and 200L

  • Floor scale

  • Suction Arms System

  • And more…

Passed European QP (EMA) audits

Media and Buffer Preparation

Grade C clean room suitable for buffer preparation

Easy to transfer buffer to upstream and downstream using wall passages in the room

Equipment include:

  • 50L to 1500L single use mixers

  • Powder transfer system

  • 200L and 500L storage containers

  • Suction arms system

Water for injection (WFI) production

USP/EP WFI grade

Cold and hot distribution loops

 

Technical R&D Laboratories

Process development laboratory for lab scale optimizations

Suitable for both Upstream and Downstream

Equipment include:

  • Ambr® 250, 2L and 5L fermentors for upstream process development & optimization

  • 30L fermentor for upstream GMP production

  • Akta Pure for protein purification

  • Sartorius TFF lab scale for concentration and diafiltration

  • HPLC

  • Chemical and biological hood

  • Large capacity and lab centrifuges

  • LOD scale (loss of drying)

Quality Control (QC) Laboratories

State-of-the-art laboratory for quality control tests

Equipped for cGMP facility routine tests and process samples

Analytic tests for:

  • Spectrophotometry for Total Protein Content (EP, USP compendial assay)

  • Immunochemical assay by BLI technology for In-vitro potency (quantitation) and affinity characterization

  • Particles size analysis

  • Product and process related impurities (SDS-PAGE, Western Blot, SEC-HPLC, RP-HPLC, CE-SDS + cIEF SEC)

  • Physicochemical methods for Identity assay, Purity, and Heterogeneity (SDS-PAGE, Western Blot, HPLC, CE-SDS + cIEF)

  • Host cell protein impurities (ELISA)

  • Endotoxins (Turbidity assay)

  • Bioburden (Membrane Filtration)

  • Sterility test

  • General tests for TOC, pH, Conductivity

Equipment:

  • OCTET R8

  • Simple Protein, Maurice (CE-SDS + cIEF)

  • HITACHI HPLC (FL)

  • HITACHI HPLC (UV)

  • PCR

  • GS-900 Imaging Densitometer

  • Nanodrop

  • Particles size LUM Lumisizer

  • and more…

 BiondVax’s facility also includes:

Control System – Building Management System (HVAC, Clean Rooms, Utilities, Freezers), in accordance with GAMP 5 and CFR part 11.

OFA system –  1.2Nm³/min in accordance with ISO 8573 class 2,3,2.

Oxygen System – Cylinder batteries distributing to clean rooms and labs

CO2 – Cylinders and distribution to labs

Chiller – Capacity of 190 T.R.

Glycol Chiller – 5KW cooling capacity

Liquid Waste System – 5000L collection vessels for direct chemical and biological waste

 

BiondVax’s People: Deep & Relevant Capabilities

  • Amir Reichman, CEO

    Senior leadership positions at GSK Vaccines, Belgium; Global pharmaceutical engineering & 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 BiondVax’s original 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, Head of Technical R&D

    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)

  • Zohar Gadri, Upstream Technical R&D 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, Downstream Technical R&D 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.

  • Merav Kamensky, Senior Manager 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.

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

    More than 20 years of biopharmaceutical R&D industry experience with expertise in the development of analytical methods.

    Ph.D. Pharmaceutical Sciences (Hebrew University of Jerusalem)

  • Dr. Tehila Sonnenfeld

    Dr. Tehila Sonnenfeld, Director of Production

    Over 15 years of extensive experience in aseptic production activities under GMP conditions.

    Ph.D. Biochemistry (Hebrew University of Jerusalem)

 

Our 1850m² GMP biologics manufacturing facility is based in Jerusalem’s southwestern outskirts in the Jerusalem BioPark on the Hadassah Ein Kerem Hospital University Campus.

> BiondVax CDMO brochure

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