synbias pharma

About Synbias Pharma
Group overview

Established in 1995, Synbias Pharma is a pharmaceutical company focused on Active Pharmaceutical Ingredients (APIs), Custom Synthesis and Fermentation projects, Finished dosage forms development. The headquarters are located in Schaffhausen, Switzerland with manufacturing and R&D sites in Germany, Ukraine and the Czech Republic.

The main specialization is APIs for cancer therapy including:

  • Anthracyclines

  • Nucleosides

  • Plant alkaloids

  • Taxanes

  • Synthetic anticancer API

Synbias Pharma is a leading global API supplier of anthracycline antibiotics with 30-50% share of the world market.

Synbias Pharma is a privately-owned company.

Key facts
  • 1995

    Foundation of Synbias Pharma Ltd in Donetsk Ukraine

  • 1998

    Launch of Doxorubicin production

  • 2001

    Start of Epirubicin manufacturing

  • 2004

    First EMA inspection

  • 2007

    First US FDA inspection access to regulated markets

  • 2007

    Launch of fermentation plant (Daunorubicin production)

  • 2010

    Synbias dominates world market of Doxorubicin and Epirubicin

  • 2012

    PMDA Inspection

  • 2012

    Foundation of Synbias Pharma AG in Schaffhausen

  • 2013

    Acquisition of the plant in Mannheim

  • 2016

    Foundation of the R&D center in České Budějovice, Czech Republic

Products and Services
Product list
Anthracyclines
  • Doxorubicin Hydrochloride

  • Epirubicin Hydrochloride

  • Idarubicin Hydrochloride

  • Valrubicin

  • Pirarubicin

Plant Alkaloids
  • Vinorelbine Bitartate

  • Irinotecan Hydrochloride

  • Topotecan Hydrochloride

Nucleosides
  • Cladribine

  • Nelarabine

  • Clofarabine

  • Fludarabine

  • Decitabine

  • Pentostatin

Taxanes
  • Docetaxel

Alkilators
  • Bendamustine

  • Carmustine

Antineoplastic and Immunomodulating Agents
  • Ixabepilone

  • Everolimus

Custom Synthesis & Contract Manufacturing

Synbias Pharma is an expert contract manufacturing partner and custom synthesis services provider for pharmaceutical companies worldwide. We manufacture intermediates and Active Pharmaceutical Ingredients according to the quality requirements of our customers and provide comprehensive support during registration. Our team has significant experience in route development, optimization, scale-up pilot and commercial scale chemistry for GMP and non-GMP productions.

Our custom synthesis and contract manufacturing services include:

  • Literature, patent, database searches

  • Route selection

  • Process development and optimization

  • Identification and synthesis of proposed impurities or metabolites

  • Analytical method development and validation

  • Synthesis and purification of analytical reference standards

  • Reference standard qualification

  • Product release testing /product retain

  • ICH stability studies

  • Drug master file generation and regulatory support activities

Finished dosage forms development

We can work with you to overcome even the most complex challenges, ranging from improving patient compliance to expanding indications. The Synbias Pharma team can support novel formulation and generic development.

TECHNOLOGIES & CAPABILITIES
Strain improvement

Our program starts either from existing technology or from a wild strain and includes improvement of strains capability with the aim to either increase the yield of the target product or improve the impurity profile of the strain. The researches have over 15 years experiences with strain improvement, mainly streptomyces and fungi.

Strain improvement methods include application of random mutation by selected mutagens and/or genome shuffling/ protoplast fusion as a principle approach for new strain preparation, random screening, metabolism re-modelling methods (use of antibiotic re-modelling compounds, use of rare earth elements, and metabolic pressure,) and selection of metabolite resistant strains.

The program includes optimization and stability testing of new candidate strains as well as media and process optimization. Shake-flask and 1 l fermenters data are used as starting point to test and develop fermentation process. Processes are further optimized in lab scale 20 liter fermenters with the aim to optimize physical and chemical parameters for growth and production of target product. Production of both the main product and impurities are controlled during the whole optimization process to support later downstream operations.

Strain improvement processes are optimized by using of DOE.

Microbial screening

Activation of cryptic silent biosynthetic pathways is explored in a screening for the ability to synthesize specific metabolites. Our researchers have conducted successful microbial screening programs using both commercial or propriety culture collections as sources of potential producers.

Finished dosage forms development

We are providing complete formulation development from early pre-formulation to a robust formulation solution in solid dosage forms (tablets, capsules, granules). Since the majority of new APIs are poorly water soluble or even water-insoluble our major task is to formulate mainly water insoluble API. Our researchers have long term international recognized experience in formulation of water insoluble APIs, such as e.g. cyclosporine, tacrolimus. We can apply different approaches from a simple direct compression/mixing method through solid dispersion up to delivery system.

  • UPLC-MS, GC-MS

  • 3 UPLCs

  • 10 HPLCs

  • 2 GCs

  • ICP-OES spectrometer

  • Preparative HPLC

  • XRD diffractometer

  • TOC analyzer

  • Particle size analyzer

  • Dissolution testing system

  • 6 Environmental Test Chambers

Full analytical service is provided by in-house analytical laboratory. DOE is a standard part of our finished dosage form development program.

API Production

Synbias Pharma is specialised in the production of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) as well as in the synthesis of cytotoxic compounds. All activities are under full compliance with the worldwide valid cGMP regulations. We can provide our customers with the development of a manufacturing process for New Chemical Entities (NCE) and/or the supply of the drug substance for all phases of a product’s life cycle, beginning from material for the first clinical studies up to the commercial supply. We assure the highest quality of our APIs to enable you to run a most effective process for the production of your drug products with a consistent outstanding quality.

Pilot Plant

For ensuring a professional process development and smooth upscaling of a process for a highly potent API we operate a pilot plant applying state-of-the-art containment technologies. It consists of several reaction vessels (10 – 250 l) to run a broad range of organic reactions in the range of -15°C up to 140°C. The equipment enables us to execute distillations at reduced pressure, extractions and crystallizations to obtain the pure product. The crystalline products are isolated in closed Nutsch filters with containment discharging systems. The final API is handled in a glove box.

The containment technology of the pilot plant allows us to process material up to an OEL class < 1 µg/m3.

Commercial Plant

Our commercial plant in Mannheim, Germany is designed based on a containment concept utilizing closed systems and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access control. This puts us in a position to handle high potent compounds and cytotoxic material in a safe way. The manufacturing of highly potent APIs with an OEL < 1 µg/m3 is daily business in this plant.

A variety of reaction vessels (100 l – 1000 l, stainless steel and glass lined) enables us to perform a vast collection of chemical synthesis from -70°C up to 140°C. Distillation processes, extractions and crystallizations are used for the purification of the final products. For challenging purification tasks a commercial high pressure chromato­graphy system with dedicated columns is installed.

After crystallization of the final product the crystals are isolated in closed Nutsch filters with containment discharging systems. Final product is handled in glove boxes.

The productivity of the production lines ranges per batch from several hundred grams up to the multi kg scope depending on the process. The plant is appropriate for sophisticated multi step manufacturing of HPAPIs.

All activities in the plant are designed to be in full compliance with cGMP.

Quality System

Synbias implemented a Quality System to ensure product quality and patient safety throughout the entire life cycle of our products and targets all relevant stages of material management, process development, scale up, commercial API manufacturing and quality control.

Our Quality System is designed to fulfill Swissmedic, cGMP, FDA and customer requirements. It was developed in cooperation with Synbias Pharma Ltd with more than 12-years experience in the field of GMP compliant API manufacturing and successful GMP and FDA inspection history.

Our management will be happy to answer your questions.

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