Quality and

Sustainability

for Drug Manufacturing

Aralez Bio’s process uses low cost and readily available starting materials, thereby lowering costs and de-risking the supply chain. In addition, it uses water as the solvent, produces no byproducts, and delivers the high selectivity levels that are hallmarks of enzymatic processes.

These characteristics in turn lead to the highest purity products while also reducing waste and shortening manufacturing time.

ISO 9001:2015 Certified

Quality is Critical to Your Success

As a provider of API starting materials, we know that you demand compounds of the highest quality. We serve some of the largest pharmaceutical and biotech companies in the world and are committed to building a lasting relationship with our partners.

Our Quality Management System is ISO 9001:2015 Certified by DEKRA, Certificate No. 112522. DEKRA has been active in the field of safety for almost 100 years and is among the top one percent of sustainable businesses.

With our ISO certification, our company has improved customer satisfaction by understanding their needs, reducing errors, and developing higher standards in general. We strive to consistently provide products that meet customer and regulatory requirements.

High Purity

Aralez offers highly pure noncanonical amino acids for use in pharmaceutical, biopharma, nutraceutical, diagnostics, food, and agricultural industries. With our proprietary enzymatic platform, we are able to synthesize amino acids up to 99.9% purity as measured by HPLC and NMR.

Aralez Bio Quality Policy

Our Quality Policy is as follows:

Understand customer expectations and provide products that meet their requirements
Provide superior service to our customers and maintain cooperative relationships with our suppliers
Supply high quality non-canonical amino acids and derivatives
Increase the availability of non-canonical amino acids that are novel and can be supplied economically at scale while minimizing the impact to the environment compared to traditional chemical synthesis
Create a rewarding and safe working environment for our employees
Promote employee commitment to quality and continuous improvement
Use a quality management system to train and guide employees to achieve the quality standards outlined in the quality manual
Be recognized for efforts in sustainability as a mark of good citizenship in accordance with high ethical standards

The Biocatalysis Advantage

The demand for cost-efficient, sustainable, and reliable syntheses for commercial chemicals has never been higher.

We believe that biocatalysis is the solution to this growing need.

Lower Costs

Enzymes are easy and inexpensive to manufacture via fermentation, requiring only abundant natural ingredients to culture cells.
By virtue of their role in Nature, enzymes were evolved to transform molecules commonly found in the environment. Bioengineers can therefore repurpose enzymes to convert natural starting materials into high quality, high value products.
Enzymes reduce the cost of manufacturing and improve process sustainability by operating under much gentler conditions than traditional industrial syntheses. Enzymes do not require high pressures or temperatures, saving energy and obviating the need for highly specialized equipment or processes.

Taken together, enzymes present a robust and cost-effective approach to industrial chemical synthesis.

Fewer Steps, Reduced Waste

Enzymes are renowned for their ability to selectively perform chemical reactions.
Unlike traditional chemical methods that require protection and deprotection steps to prevent off-target reactions, enzymes can suppress undesirable reactions and selectively create products in a single step.
These characteristics enable the highest purity while also reducing waste and shortening manufacturing time.