Dec 6-7, 2021
Parsippany, NJ Hilton

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Exhibitor List As Of September 24, 2021

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Hamari Chemicals USA
Heraeus Precious Metals GmbH
HitGen Ltd

Hamari Chemicals USA, Booth Space 36 [ company website ]

Hamari Chemicals, Ltd. is a global provider of custom chemical manufacturing to the pharmaceutical industry. We have extensive experience in the synthesis and production of active pharmaceutical ingredients (APIs) and advanced chemical intermediates. Our core strengths include, synthesis of amino acid derivatives, small molecules, heterocycles, peptides, chiral intermediates, and performing transition metal mediated coupling reactions on the commercial scale. Whether your project is at the discovery stage, pre-clinical stage, clinical stage, or ready for commercial production we have the experience and expertise to help your company through the API development process.

Helsinn, Booth Space 80 [ company website ]

Helsinn is a leading Swiss CMO located in Biasca, Switzerland with over 30 years of experience in chemical development and cGMP manufacturing. Helsinn serves small to large biotech and pharmaceutical clients, supporting analytical and process development, manufacturing scale-up, optimization, registration and validation for mid to late stage clinical and commercial compounds. While focusing on synthetic NCEs, Helsinn performs a wide variety of services and chemical syntheses (see those called out below).

In addition to advanced intermediates and traditional small molecules, Helsinn has developed deep experience and strong competency in high containment manufacturing. Biasca possesses world class segregated facilities capable of handling highly potent, highly active, cytotoxic and other bulk drug substances that require specialized expertise, and appropriate containment equipment. Helsinn has over 15 years of experience with HPAIs (or HPAPIs) and the recent expansion of the new CYTO facility now offers fully segregated development and manufacturing for this special class of compounds. Helsinn offers comprehensive CMC services including regulatory and pharmaceutical support for all API needs. The production plants have a very successful global audit and inspection record with partners and regulatory agencies alike. Helsinn has been inspected by the FDA, Swiss Medic, PMDA, and the Korean agency. Helsinn’s most recent audit and PAI was April 2014 by the FDA with no 483 observations. Production scales range from hundreds of grams up to tens of tons for APIs in fully dedicated cGMP plants. Capabilities and Helsinn services are customized according to client needs on an exclusive basis.

Helsinn services Include, but not limited to:

  • Clinical and commercial manufacturing
  • CMC update and annual review
  • Registration and process validation
  • Batch record translation
  • Route optimization
  • Define all specifications & develop methods
  • Supply chain management & sourcing
  • Reference standards
  • Ongoing stability
  • Risk assessment

Heraeus Precious Metals GmbH, Booth Space 42 [ company website ]

Heraeus has more than 25 years experience in the development and production of high potency oncology APIs. Today, Heraeus offers a unique variety of technical expertise in its state-of-the-art facilities, from chemistry to fermentation processes. Regular inspections by the U.S. FDA as well as other authorities support Heraeus’ main objective of delivering high quality Contract Development and Manufacturing services.

Heraeus is a globally active precious metal and technology Group based in Hanau, near Frankfurt, and with deep roots in Germany. The company has been family-owned for 160 years. In 2010, on the strength of more than 12,900 employees in more than 120 companies, Heraeus generated product revenues of €4.1 billion and precious metals trading revenue of €17.9 billion.

HitGen Ltd, Booth table 27 [ company website ]

HitGen Ltd, a life science company based in Chengdu in SW China, has established a unique platform for early drug discovery research. Our DNA encoded libraries, containing over 0.75 billion drug-like compounds with immense diversity based upon many hundreds of distinct scaffolds, can be accessed by our partners to find novel hits and leads for even the more challenging protein classes. HitGen has established strong capabilities in protein expression, purification and conjugation, in-vitro screening and affinity selection, phenotypic target ID, chemical library design & synthesis and medicinal chemistry optimisation to facilitate rapid project progression and aims to be a leading provider in progressing projects from target to leads stage. Our geographical location and company ethos enable us to deliver clear value for our customers and collaboration partners.