Process Excellence for Successful Biopharmaceuticals

Manufacturing Strategy

Biopharmaceutical Manufacturing Strategy Services

International Manufacturing Strategy

We create the best international manufacturing strategy for the production of your biopharmaceutical products. We develop, optimize and implement effective biopharmaceutical manufacturing programs, whether your products are produced in-house, outsourced to a contract development and manufacturing organization (CDMO) or partnered. We can quantify and compare your internal versus outsourced biopharmaceutical manufacturing costs, analyze potential joint ventures and perform due diligence audits of a potential partner or CDMO.

Choosing The Best Biopharmaceutical Manufacturing Option

We can find the best biopharmaceutical manufacturing option for your product. We will identify and quantify all of the relevant project timeline components and cost elements for your project. Drawing on our extensive first-hand knowledge of both process technology transfer and the design/construction of biopharmaceutical facilities, we will ensure that all costs are quantified including:

  • Capital Costs
  • Internal Labor
  • External Services
  • Raw Materials
  • Product Storage and Distribution
  • Storage, Transport and Analysis of Process Intermediates and Samples
  • Technology Transfer Costs
  • Start-Up Expenses
  • Quality Assurance
  • Validation
  • Regulatory

Once a decision is made to either Outsource/Partner your biopharmaceutical manufacturing project or Design/Build Biopharmaceutical Manufacturing Facilities, we can provide whatever additional services you choose.

If you choose to produce your products in-house, we offer: Design/Build Biopharmaceutical Manufacturing Facilities Services

Develop The Conceptual Design

We can assist with scope definition for your cGMP manufacturing facility including:

  • Scale the manufacturing process to meet demand forecasts
  • Develop process flow diagrams that incorporate robust manufacturing-scale unit operations
  • Create facility layouts that achieve optimal space usage while allowing for all maintenance and compliance activities
  • Incorporate appropriate production and materials management automation
  • Design utility systems including HVAC, water systems and industrial gases
  • Incorporate sterile processing techniques including barrier isolators

Facility Project Execution

We can manage your facility project timeline and budget to deliver results. We can provide many of the components necessary during your facility project such as:

  • Overall project management including sequencing and project acceleration
  • Selection of process equipment vendors
  • Specification and purchase of process equipment
  • Incorporation of only necessary validation procedures under protocol (which may include design qualification, factory acceptance, site acceptance, installation qualification, operational qualification and performance qualification)
  • Contractor selection, negotiation of terms and coordination