BioProcess Consulting

Our BioProcess Consulting Services support Suppliers and End Users, both long term and during active phases such as investigations or emergencies, by quickly zeroing in on the right balance amongst science, regulations and effort. Our value is found in our customized BioProcess consulting solutions using the most concise and efficient methods possible. We have access to an array of SMEs who help us widen and deepen our knowledge base. On occasion, we have even connected our clients with these niche experts and stepped out of the way. Our high value bioprocess consulting services are primarily focused within three areas: BioProcess Engineering, Operations Know-how, and cGMP, and single-use supply chain (for Suppliers and/or End Users.)

BIOPROCESS ENGINEERING

The BioProcess Institute provides on-site bioprocess engineering consulting services for the design and operation of biopharmaceutical, pharmaceutical, food and process facilities–and the process and facilities systems contained within them–including helping you find the right component or material. Our value is in our ability to balance technology, training, and cost. We show our clients how to become one with the process by navigating through plant engineering challenges to deliver timely and effective support and guidance to best meet their business objectives. This is accomplished by effectively integrating design with operations early on (1) in the design phase, (2) during the fabrication and construction phase, and (3) during the steady-state facility operation phase.

End Users and Suppliers come to us for BioProcess Consulting services including:

  • Single-Use Adoption and Conversion
  • Strategy and Risk Assessment
  • Standards and SOP Development
  • Rouge Predictive Maintenance for Utilities and Process Equipment
  • Steam Quality Testing
  • Facilitation with Writing White Pages
  • Change Control Strategy, Implementation and Close-Out
  • Technical Investigations
  • Quality by Design
  • Cost of Change
  • Subject Matter Expert (SME)
  • Audit Response Reliability

OPERATIONS KNOW-HOW

Sometimes you need a coach. Sometimes you need a referee. And sometimes you need both. Businesses are complicated teams. Having all the right players doesn’t necessarily make the team productive. Successful businesses have discovered the secret to making their teams work well, internally and externally. The BioProcess Institute assists clients in overseeing the management of their operations in the most efficient and effective ways possible. We provide our clients with guidance in:

  • Maintaining robust, compliant, and sustainable systems and facilities;
  • System and equipment evaluations;
  • Maintenance program evaluations; and
  • Balancing the cost vs. risk involved with cGMP, safety, and environmental regulation compliance.

Suppliers and End Users come to us for Operations Know-How Consulting services including:

  • Staff Consensus Facilitation
  • Cost of Change
  • Facility Reviews
  • Project Justification
  • Single-Use Component Information/Manufacture
  • Contamination Investigation
  • Operation Excellence
  • Expert Witness Testimony
  • Third Party Opinion Leader
  • Arbitration
  • Facilitation
  • Vendor Relations
  • Merger and Acquisition
  • Voice of the Customer (VOC)

 cGMP (CURRENT GOOD MANUFACTURING PRACTICES)

The key is to determine how to satisfy cGMP requirements while maintaining your company’s ability to thrive and succeed. Our goal is to get in and get out. The BioProcess Institute’s industry professionals have the key knowledge and experience to help your company navigate through the complex and highly detailed world of cGMP regulations–including regulatory risk and contamination–without wasting your valuable company resources. We are adept at providing the right amount of direction and skilled guidance, without overstaying our welcome.

Suppliers and End Users come to us for cGMP Consulting services including:

  • Change Control Strategy, Implementation, and Close-out
  • Technical Investigations
  • Regulatory Investigations
  • Subject Matter Expert (SME)
  • Project Justification
  • Single-Use Component Information
  • FDA 483 Remediation Expertise
  • Standards and SOP Development
  • cGMP Risk Assessment
  • Environmental Monitoring
  • Root Cause Investigations
  • Non-Conformance/Corrective And Preventive Action (CAPA)
  • EMEA/FDA/ISPE Expertise
BioProcess Consulting