Pharmaceutical Product Development

Accelerate Biopharmaceutical Development

When you partner with Xybion for product development, you not only gain access to the Labwise XD platform, but to a team that has demonstrated expertise in expediting drug, device, and therapeutic formulations.

With the Labwise XD formulation management module, you can tailor protocols and study designs. The digital platform allows scientists in product development departments at biopharmaceutical and generic drug companies to perform step-by-step online foundations based on established methods.

With Xybion, you have access to a single cloud-based digital platform to simplify your supply chain.

With Labwise XD – Pharmaceutical Product Development, you can:

Highly customizable to meet site-specific SOPs.

Maintain materials master records.

Materials archival & disposal records

Materials inventory management & tracking

User-defined template formulation instructions

Wide variety of
formulation types

Online execution
of formulations

Supervisory reviews
& approvals.

Bar code labeling & scanner interfaces

Bi-directional interface for balances

21 CFR Part 11 electronic signatures & audit trail compliant

Laboratory Inventory Management System

The Labwise XD LIMS module includes material receipt, registration of the material supplier and manufacturer, and movement of materials among laboratory areas. With the LIMS module, you can:

  • Track movements of drug substances, vehicles, and excipients by container or by user or date.
  • Easily prepare hazard statements and special handling with the “master paragraph” functions.
  • Develop and execute drug formulation worksheets based on inventoried materials.

Substance Management

Our substance management capabilities provide the capability of describing laboratory materials that are to be inventoried and tracked by recording receipt, movement, and use of materials. Labels and inventory reports may be generated immediately following the registration of new material or new containers.

The extremely flexible and user-friendly interface is used to define standard formulation procedures. With Labwise XD, you can:

  • Design and implement workflows matching the formulation process.
  • Record details, such as weights performed during the formulation, additional recording equipment, comments, pH, or stir-times Target list.

Target List Calculations

Target list calculations include direct addition (where the substance is mixed with the vehicle directly in the formulation container), stock dilutions, and serial dilutions.

The target list execution module provides an overview of the calculated measurements to perform, the steps that need to be performed, and then detailed, step-by-step instruction sequences.

Ready to learn more? Book a free demo.