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Services

Biosynth Carbosynth offers a range of services to pharmaceutical and diagnostic industries includig custom synthesis, large-scale manufacturing, API manufacturing, CDMO services, sourcing and others. More detailed information on each service offered is outlined below.

For all inquiries on services, please contact us here.

 

Custom Synthesis

Biosynth Carbosynth provide custom synthesis solutions tailored to meet your needs. Our synthetic laboratories operate from modern facilities based in the United Kingdom, Switzerland, Slovakia and China.

 

Custom synthesis box_3

We specialise in the following chemistries:

  • Functionalised carbohydrate building blocks and derivatives
  • Oligosaccharide synthesis
  • Nucleosides, dinucleotides and analogues
  • Heterocyclic chemistry
  • Novel enzyme substrates
  • Natural product synthesis
  • Impurities and metabolites
  • Protein conjugation, biotin and click linkers
  • Fluorination, phosphorylation and sulphation chemistry
  • High purity complex products
  • Synthetic route development
  • Regulated materials

 

 

Our scientists are predominantly Ph.D-qualified and have extensive industry experience in carbohydrates, imino sugars, glycosylations, nucleosidations and medicinal chemistry. Our state-of-the-art laboratories are equipped with  modern preparative and analytical equipment. 

 

Terms of service

  • Small-scale to bulk quantities
  • Experienced chemists, predominantly Ph.D.-qualified
  • Timeliness
  • Confidentiality
  • ISO-certified quality management system - ISO 9001:2015.

 High quality, on-time delivery and confidentiality are at the core of our service.

 

Large-scale manufacture

We manufacture a variety of product types that are applicable for pharmaceutical, diagnostic, analytical and research purposes from small-scale to large-scale. Our team of highly experienced chemists and technicians enable versatility in the quantities of products that can be manufactured.

 

Product Applications 

  • Carbohydrate-based drugsServices - Large Scale Manufacturing
  • Carbohydrate-based detergents
  • Antiviral nucleoside analogues
  • Substrates for detection of enzymatic activity
  • Food and environmental analytical compounds
  • Cosmetic ingredients
  • Nutraceutical ingredients

 

Our service

  • Prompt and efficient production flow
  • Consistent supply
  • High-quality assurance – ISO 9001:2015 compliant and cGMP (Swiss plant)
  • Third party supplier selection

 

 

Services - Manufacturing in Europe

Manufacturing in Europe

We have two manufacturing sites in Europe which are based in Staad, Switzerland and Bratislava, Slovakia.

The facilities are modern with reactors up to 3000 L and equipped with cutting-edge instrumentation to support our production and analytical processes. The site in Switzerland is GMP compliant and has a GMP pilot plant for medium size production (1 – 10 kg batch size) and a GMP production plant with up to 3000 L reactors for bulk batch sizes.

 Scale: up to 5 Mt

 Compliance with:

 - GMP
 - PMDA
 - ISO 9001:2015

 

 

 

Services - Manufacturing in China

 Manufacturing in China

Our multi-purpose plant was built in 2015 in Jinan, China and is part of the CarboTang Biotech Joint Venture between Biosynth Carbosynth Group and Shengquan Group.

This large-scale manufacturing plant is multi-purpose and flexible with separate chemical and pharma halls, which are built and equipped according to a GMP-like standard (no GMP accreditation).

The plant is constructed to meet EU regulation, including Directive 2011/62/EU, US FDA, CFDA and is compliant with ISO9001:2015 and ISO14001:2015 quality standards.

Scale: from 100s kg to 10 Mt

  

 

 

 

 

 

API manufacturing

Our state-of-the-art GMP-compliant plant in Switzerland performs pilot and production runs in 100 L reactors as well as small scale API manufacturing.

We are a GMP, PMDA and ISO 9001:2015 compliant company. We perform in-process and final control of each API in our Swiss quality control laboratory as we have all modern analytical equipment available in-house. All procedures are validated.

 The route from your need to cGMP product includes strategic and tactical considerations.

  

Quality control and quality assurance

Services - QA and QC

 All our analytical equipment for quality control is of the highest standard, certified and available in-house so we can perform in-process and final control of products.

The quality assurance continuously adapts processes to the requirements of the market and ensures consistent compliance at all stages of the supply chain, from production to delivery and beyond. Our QA team supervise the quality and performance of all business and manufacturing processes.

We operate a company-wide quality management system and perform regular internal audits. Special attention is given to compliance issues, particularly to API manufacturing, testing and handling, change control requirements, method and process validation, controlled substance handling and documentation. 

 

 

CDMO services

 We help pharmaceutical companies to compress time-to-market by providing integrated contract development and manufacturing services. Our expertise in carbohydrate and nucleoside chemistry is unrivalled on a global scale, and we can design efficient and effective processes to produce your carbohydrate or nucleoside-based pharmaceutical ingredients.

Our modern and versatile facilities allow us to be flexible and customise projects to your requirements. We have a GMP-certified plant for the production of APIs based in Switzerland, with qualified clean room labs, production and filling facilities.

 

 Our CDMO services include:

  •  Process development
  •  Analytical development
  •  Route scouting
  •  Pilot manufacturing
  •  Scale-up
  •  Management of outsourcing activities
  •  Quality assurance
  •  Regulatory support

 

Custom filling and packaging

 We can custom fill any required amount and in any required container. APIs and highly toxic materials are handled in containment with Clean Room Class 8. Our filling and packaging capabilities are featured by:

  •  Handling within ISO 144644-certified Clean Room Class 8
  •  Packing under inert conditions (nitrogen)
  •  Packing within a glove box or an automated, qualified solids dosage system
  •  Permitted to manufacture, store, ship and sell controlled substances

  

Logistics and warehousing

Our warehouses are strategically located on three continents; in Europe we stock products in Switzerland, the United Kingdom and Slovakia. In Asia we have warehouse capacities in two locations in China: Suzhou and Jinan. In the USA, we have our warehouse in San Diego.

Our warehouses are temperature controlled and equipped with all necessary permits for the handling of highly regulated material. We also have clean rooms to handle special packaging requirements.

 Services - Warehousing

 

Sourcing

We have extensive experience and a vast database of suppliers all around the world. Many of our trusted suppliers are also capable of taking on outsourced work from us if required to help fulfil client demands and timelines.

We have sourcing experts based in Suzhou in China to meet demands for fine chemicals beyond our catalogue range and to mitigate the risk of sourcing in China. Our facilities in Suzhou enable competitive and efficient outsourcing services, focusing on quality and professional management.

Our suppliers are carefully selected, audited and we also perform quality control of products in-house.

 


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