Wednesday, February 4, 2026

Why Regeneron selected Amazon RDS Customized for Oracle to deploy COTS and GxP functions on AWS


It is a visitor submit by Prerak Raghuvanshi, Principal IT Engineer at Regeneron Prescription drugs, in partnership with AWS.

Regeneron, a number one biotechnology firm, successfully harnesses conventional on-premises options with a complicated database structure to bolster important commercial-off-the-shelf (COTS) and GxP enterprise functions. The corporate strategically aligns with vendor suggestions tailor-made to accredited use instances, thereby guaranteeing optimum efficiency and compliance for his or her lab administration, medical, and manufacturing programs. In selecting a database engine for these enterprise functions and SAS-based options, Regeneron navigates a centered choice course of. Regardless of going through some vendor-imposed constraints, their devoted database engineering staff excels in sustaining excessive requirements and implementing modern options inside these parameters. This method underscores Regeneron’s dedication to leveraging cutting-edge know-how whereas adhering to business requirements and greatest practices.

As a part of Regeneron’s cloud-first technique, the database engineering staff has adopted Amazon Relational Database Service (Amazon RDS) as their most popular possibility for migrating or deploying varied COTS and GxP functions on AWS. This method helps them decrease operational overhead, optimize prices, and improve availability. For legacy COTS and GxP functions that want customization of the database, underlying server, and working system configurations, which aren’t supported on RDS for Oracle, they make the most of Amazon RDS Customized as the usual answer.

The database engineering staff at Regeneron applied a number one manufacturing COTS software on Amazon RDS Customized for Oracle to streamline operational overheads within the manufacturing course of. This allowed Regeneron to automate important database administration duties, offering database directors the pliability to customise each the database atmosphere and working system to exactly match the distinctive wants of their functions. The automation of backups and different operational duties not solely reinforce information safety and improved resilience in opposition to potential failures but additionally enormously simplified deployment complexities historically related to on-premises programs. Moreover, the scalability provided by RDS Customized ensures that Regeneron’s database infrastructure can optimally adapt to their ongoing enterprise development, showcasing their dedication to innovation and operational excellence.

On this submit, we spotlight why Regeneron selected to make use of Amazon RDS Customized for Oracle to deploy COTS and GxP functions on AWS. This choice underscores their dedication to advancing from a legacy structure to a sturdy, scalable, and resilient managed service. By doing so, Regeneron not solely enhances their backend database infrastructure but additionally ensures adherence to GxP procedures, demonstrating their dedication to operational excellence and regulatory compliance.

Key options of RDS Customized for Oracle

Regeneron wanted to deploy a producing planning and scheduling software to assist complicated bio-pharma manufacturing processes. This software include vendor supplied customized database scripts to create logical construction and varies by software. Many of those scripts must be run with elevated privileges similar to ‘SYSDBA’ within the database and create varied software particular object buildings.

RDS Customized for Oracle offers added flexibility emigrate legacy on-premises COTS functions to the cloud by enabling specialised customizations to each the underlying database and working system. This managed service is especially helpful for Oracle business specialised functions in sectors like healthcare and life sciences, combining the advantages of database automation with the customization capabilities wanted for complicated enterprise workload

Some key advantages of RDS Customized embody the power to automate most of the identical administrative duties as Amazon RDS, similar to lifecycle administration of databases, automated backups and point-in-time restoration (PITR), absolutely managed learn replicas, monitoring the well being of RDS Customized DB cases, and observing adjustments to the infrastructure, OS, and database processes. Additionally, extra advantages which can be particular to RDS Customized are the aptitude to configure third-party functions, set up customized patches, achieve elevated privileges to put in legacy functions, in addition to the power to create your personal customized automation.

Answer overview

The next diagram exhibits the important thing elements of the RDS Customized structure. The RDS Customized DB occasion resides in a digital personal cloud (VPC) and consists of the EC2 occasion, occasion endpoint, OS put in on the EC2 occasion, and Amazon Elastic Block Retailer (Amazon EBS) for any extra file programs.

With RDS Customized, it’s important to use your personal database media. This service mannequin is called Deliver Your Personal Media (BYOM). To get began, you could create a customized engine model (CEV), which is a binary quantity snapshot of a database engine and a selected Amazon Machine Picture (AMI). For Oracle databases, the method includes storing the required set up information and patches in an Amazon Easy Storage Service (Amazon S3) bucket. RDS Customized then makes use of these information together with the AMI to create the CEV. When the CEV is prepared, you possibly can create an RDS Customized for Oracle DB occasion, which shall be primarily based on the CEV you supplied. To get began with CEV creation, consult with Working with customized engine variations for Amazon RDS Customized for Oracle.

RDS Customized has exterior automation and monitoring software program that communicates with brokers on the DB occasion and different elements throughout the RDS Customized atmosphere. This software program is chargeable for accumulating metrics, performing backups, sending notifications, performing computerized occasion restoration, and resolving points with the underlying EC2 occasion. You’ll be able to pause automation mode when performing customizations to forestall unintended interference with RDS Customized automation. RDS Customized offers full entry to the host so that you can make adjustments. So long as the adjustments don’t intervene with RDS Customized automation, the host shall be throughout the assist perimeter; in any other case, will probably be outdoors the assist perimeter. You’ll be notified when a bunch is outdoors the assist perimeter.

Utility structure

Regeneron used Amazon RDS Customized for Oracle to deploy a producing planning and scheduling software that wanted admin rights on the database server. The first database occasion is deployed in a single Availability Zone (AZ), and one other standby occasion is configured in a distinct AZ. Oracle Information Guard synchronizes the first and standby cases in real-time. Customers entry the appliance utilizing Amazon AppStream 2.0. AWS Direct Join is getting used to supply a personal community connection between Regeneron’s company community and AWS.

Challenges and classes realized

This was Regeneron’s first RDS Customized deployment. Throughout configuration and testing, they realized fairly just a few issues that they’re excited to share with the neighborhood. RDS Customized for Oracle offers elevated privileges (similar to SYSDBA) to entry the database and carry out customized installations on the RDS Customized host, which allowed them to fulfill their particular software necessities. In the course of the course of, they needed to study a brand new solution to apply modifications and customizations on the host by turning off the automation, making adjustments, after which turning it again on. For extra details about frequent upkeep greatest practices you could comply with, consult with Make configuration adjustments to an Amazon RDS Customized for Oracle occasion: Half 1. On this part, we focus on classes learnt all through the implementation.

Preliminary Setup

Earlier than you create an RDS Customized for Oracle occasion, be sure that all of the stipulations, together with the required AWS Id and Entry Administration (IAM) insurance policies, are applied. Additionally, modify any service management insurance policies (SCPs) applied in your account as wanted to permit these IAM insurance policies.

RDS Customized cases create their very own AWS CloudTrail log group. If you wish to use one other current or new CloudTrail group, we advocate reaching out to AWS Help and opening a assist case to permit this.

Patching

Amazon RDS Customized for Oracle offers versatile database patching capabilities by means of the OPatch utility, providing two distinct approaches to keep up their database environments.

Our advisable method leverages Customized Engine Variations (CEVs), which streamlines patch administration throughout a number of database cases. On this method we create a brand new CEV containing the specified Oracle Database Launch Replace, then modify the DB cases to undertake this model. This methodology proves significantly helpful for managing a number of cases, as a single CEV may be utilized persistently throughout the database fleet.

For time-sensitive conditions requiring instant patch deployment, RDS Customized additionally helps handbook “one-off” patching. This method includes quickly pausing RDS Customized automation, making use of patches on to the database binaries on the underlying EC2 occasion utilizing OPatch, after which resuming automation. Whereas efficient for pressing situations the place CEV creation timelines don’t align with enterprise wants, this methodology is advisable solely when normal CEV workflows can’t meet crucial patching deadlines.

Operations

You shouldn’t modify the default shell on the system degree as a result of which may intervene with the RDS automation and your occasion could also be put outdoors the assist perimeter. If you could run any script utilizing a distinct shell (similar to utilizing a Korn shell as a substitute of the default bash shell), we advocate doing so on the session degree to run any particular instructions or scripts relatively than altering it on the host degree. Regeneron enhanced its database safety by implementing Amazon RDS Customized for Oracle’s complete encryption capabilities, using AWS Key Administration Service (AWS KMS) for data-at-rest encryption and TLS for data-in-transit safety, creating a sturdy safety framework for its delicate database workloads.

Backup

Regeneron makes use of their very own enterprise information safety device,Druva to seamlessly combine with RDS customized for Oracle. On this means we’re capable of retailer backups for long-term to fulfill our compliance requirement in addition to utilizing the identical information safety device for on-prem, self-managed and RDS databases for a unifying information safety expertise. We’re taking RMAN backup of the RDS Customized EC2 utilizing Druva Direct to Cloud (DTC) and likewise snapshot backups of the RDS occasion

Monitoring

We now have added the RDS customized for Oracle occasion as a goal for the Oracle Enterprise Supervisor (OEM) monitoring device. This allow us to incrementally modernize our database atmosphere whereas retaining the identical monitoring device used for on-premise and cloud atmosphere. We may additionally leverage current database efficiency device, SolarWinds DPA, to carry out our question tuning and optimization workflows. The flexibleness of RDS customized for Oracle to combine with current observability and information safety instruments accelerated our launch time and diminished the necessity of re-skilling our workforce.

Total, RDS Customized for Oracle supplied us numerous flexibility to run legacy functions that want elevated database privileges and customization, however any customization you’re acting on the occasion should be examined in a decrease atmosphere to validate that they’re absolutely supported by the RDS automation. For extra details about frequent customizations you may wish to implement, consult with the collection Make configuration adjustments to an Amazon RDS Customized for Oracle occasion. You can even use AWS CloudFormation primarily based automation to implement a Multi-AZ configuration for reaching excessive availability for deploying mission-critical functions on RDS Customized.

Abstract

With the profitable deployment of the primary GXP COTS software on Amazon RDS Customized for Oracle, Regeneron is now capable of focus extra on strategic initiatives like cloud and database structure design, relatively than routine duties similar to managing on-premises backups. The distinctive function of Amazon RDS Customized, which permits for custom-made deployment with elevated entry, has expedited Regeneron’s cloud migration by leveraging managed providers. As Regeneron plans emigrate extra functions to AWS, they intend to make the most of RDS Customized (together with RDS Customized for SQL Server) for functions that require elevated privileges or host-level customizations, the place conventional Amazon RDS might not suffice. By simplifying manufacturing deployment and upkeep, Amazon RDS Customized aids in decreasing lead occasions, thereby enabling organizations to swiftly reply to buyer wants and speedy market adjustments.

Check out RDS Customized to boost your personal legacy on-premises options, and tell us your suggestions and questions within the feedback part.


In regards to the authors

Prerak Raghuvanshi

Prerak Raghuvanshi

Prerak serves as a Principal IT Engineer and heads the Database Engineering Apply at Regeneron Prescription drugs. Based mostly in New Jersey, he brings over 18 years of experience spanning biopharma, healthcare, and engineering domains.

Sachin Jain

Sachin Jain

Sachin is a Senior Options Architect at AWS with give attention to serving to Healthcare and Life-Sciences clients of their cloud journey. He has over 20 years of expertise in know-how, healthcare and engineering house.

Saikat Banerjee

Saikat Banerjee

Saikat is a Sr. Database Options Architect with Amazon Net Companies. He works with clients to modernize their database structure on AWS.

Sanjoy Thanneer

Sanjoy Thanneer

Sanjoy is a Sr. Technical Account Supervisor with AWS primarily based out of New York. He has over 20 years of expertise working in Database and Analytics Domains. He’s obsessed with serving to enterprise clients construct scalable, resilient and cost-efficient Purposes.

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