Pharmaceutical Development

Developing a new drug from original idea to the launch of a finished product is a complex process which can take upwards of fifteen years and cost in excess of $1 billion. To remain competitive, research centers must find ways to streamline early processes to identify molecules which possess suitable characteristics. Increasingly this means optimizing business processes such as data capture, consolidation, and analytics across the drug discovery process, from initial target identification and validation, through assay development, high throughput screening, hit identification, lead optimization and finally the selection of a candidate molecule for clinical development.

Xybion’s Labwise-XD platform is uniquely positioned, offers comprehensive business process enablement for today’s global laboratory enterprise, resulting in faster cycle times, reduced IT costs, and increased innovation. As a fully configurable, laboratory-centric business process management platform, Labwise-XD enables critical business processes in preclinical and early development, such as (but not limited to):

  • Material Management Workflows
  • Equipment Lifecycle Management
  • Quality and Compliance management
  • Document distribution and approvals, including SOPs, Work Instructions, Assay Development Methods
  • Process Chemistry Methods, and
  • Issue tracking for regulatory submission management purposes, supporting the creation of IND and NDA packages

For pre-clinical laboratories operating in both GLP and non-GLP environments, Xybion offers an end-to-end solution that begins with data capture, through data consolidation and aggregation, into data analytics and reporting.
By leveraging Labwise-XD’s integration with the Pristima® and Savante™ platforms, Xybion offers an out-of-the-box solution for preclinical study management, data capture, analytics, consolidation, and process compliance enablement.

Learn more about Xybion solutions for discovery, pre-clinical, and early development:

Pharmaceutical Development (New Drug And Generics)

Xybion’s Labwise platform offers out-of-the-box, pre-configured workflows to support Pharmaceutical Development laboratories operating under both GMP and non-GMP conditions. Functions to support and integrate analytical development, method development, chemical development, and formulation development activities promote continuous improvement, operational efficiencies, and reduced costs.

Labwise enables the management of typical material, process, and equipment workflows associated with developing new drug entities and generics, such as:

  • Formulation management
  • Tracking analytical methods
  • API and associated recipe approvals
  • Unit operation process handling and tracking
  • Replacement for equipment paper log books, enabling tracking of calibration schedules, vendor
  • maintenance, and more

Single Digital Platform for Generic & OTC Manufacturing

Generics Manufacturers are subject to the same strict regulatory scrutiny and enforcement as larger Pharmaceutical Organizations. However, Generic companies are forced to meet these standards with fewer resources and tighter margins than ‘Big Pharma’. Xybion’s Generics XD (GXD) digital platform is uniquely developed to satisfy the demands of Generic Pharmaceutical and OTC manufacturing organizations.

The following industry challenges can become overwhelming to Generic and OTC manufacturers that have not invested sufficiently in their digital infrastructure:

Industry Challenges

Digital Platform Benefits

Competitiveness in a Crowded Marketplace

Tighter Margins

Limited Resources

Same regulatory scrutiny and enforcement as “Big Pharma”

Data Integrity

Reduced ramp up time, reduced manufacturing errors, and improved quality

Improved efficiencies and hard cost savings

Optimized operations – higher throughput with existing resources

Pre-configured workflows and audit ready reporting – reduces audit risk

Supports ALCOA Principle: Ensures that data are complete, consistent, and accurate

Out-of-the-Box Functionality

With its pre-configured workflows and ready to deploy functionality, GXD provides you with the digital platform and tools to effectively manage your daily operations:

  • Change Management
  • Document Control
  • Calibration Management
  • Corrective and Preventative Actions
  • Audit Management
  • Complaint Handling
  • Compliance Management
  • Employee Training

This cloud-based solution allows customers to deploy the solution rapidly and adapt to existing requirements without the complexities of configuration and ongoing maintenance.  However, GXD is built on Xybion’s highly configurable, low code technology stack which facilitates “configurations” vs. “customizations.” In layman’s terms, this simply means that we can deliver client specific workflows and processes in DAYS as opposed to MONTHS with older legacy based applications. This also means that our clients are provided a high level of control allowing them to change and configure their instance WITHOUT affecting core code, hence no need to re-validate.

Meeting Your Needs Today AND in the Future

In addition to being out-of-the-box ready, GXD is a modular platform, meaning that additional functionality or modules can be deployed rapidly without disrupting existing business operations and ensuring business continuity. This modular approach allows you commit to and deploy ONLY the functionality that you need TODAY and remain positioned to scale and ramp up rapidly new functionality as needed. GXD provides One Platform and One Solution to meet your digital workplace demands wherever you are at in your manufacturing journey.

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