Consulting & Industry Navigation

The BioProcess Institute offers a straight-forward approach to addressing our clients’ needs. We develop
customized solutions for each client through the most concise and efficient methods possible.

Our high value consulting services are primarily focused within the areas of

  • BIOPROCESSING ENGINEERING
  • OPERATIONS MANAGEMENT
  • CURRENT GOOD MANUFACTURING PRACTICES (CGMP)

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). We help our
clients 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. We accomplish this by
effectively integrating design with operations in the following ways.

Prior to—and early on in—the Design Phase: We help project teams outline the project's objectives to
meet business needs by defining core design philosophies, user requirements, and responsible parties.
During this phase, we also help our clients focus on what is possible, clarify issues, and streamline the
decision-making process to meet their commercial, technical, and quality objectives. We do this in four
major steps. First, we ensure that the design intent is maintained by aligning the design documents with
the design philosophies. Next, we ensure the regulatory risks (cGMP, safety, and environmental) are
assessed and evaluated against the business drivers. Then, we ensure that Good Engineering Practice is
maintained and that the implementation meets the sustainability requirements. Last, we perform design
qualification and design reviews.

During the Fabrication and Construction Phase: We help define operation parameters, facilitate
vendor relationships, orchestrate system verification studies/reports, troubleshoot start-up issues,
establish maintenance practices to support operations, and assist with regulatory inspection preparation.
The introduction of Single-Use components into the field of bioprocess engineering has presented as
many benefits as challenges. BPI has had great success customizing and implementing multiple Single-
Use products into various applications for our clients. We specialize in determining how to use what you
already have in an effort to avoid retooling. It isn't always necessary to start from scratch because we
work within your constraints using our process knowledge and experience. We're not going to take you
through the woods if a road already exists.

During the Steady State Facility Operation Phase: We help our clients maintain robust, compliant and
sustainable systems and facilities, while constantly remaining aware of current Good Manufacturing
Practices (cGMPs). We routinely perform system and equipment evaluations to address operational
issues, regulatory requirements, and process/equipment optimization. In order to ensure that the facilities interface seamlessly with the process, we also structure SOP and Standards development.

BIOPROCESS ENGINEERING CONSULTING AT-A-GLANCE

  • Single-Use Adoption/Conversion
  • Strategy and Risk Assessment
  • Standards and SOP Development
  • Rouge Predictive Maintenance for Utilities and Process Equipment
  • Steam Quality Testing
  • Change Control Strategy, Implementation and Close-out
  • Technical Investigations
  • Quality by Design
  • Cost of Change
  • Subject Matter Expert (SME)

Downstream Process Improvement Test

Customized DNA Database Test

OPERATIONS MANAGEMENT
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. Here’s how we do it:

  • As a coach—BPI plays a vital role in helping managers make tactical decisions aimed at improving their team’s growth and core processes through staff consensus facilitation, arbitration, staff development, etc. We also provide staff mentoring including general and specialized training on technical topics, cGMP and in-depth product training. Our fresh set of eyes and our sense of the conditions (people, technology, cGMP, etc.) qualify us to help your company navigate through this complicated world of bioprocessing.
  • As a referee—BPI cultivates successful relationships -- both between individuals and parties within a company, as well as between your business and outside players such as vendors, who often seem to be speaking a different language entirely.
  • As both—BPI concentrates on knowing when to be the coach and when to be the referee, because a certain understanding is necessary to find the right balance between the two and knowing when to switch hats.

Oftentimes managers struggle with the balancing act of time, staff development, regulations, and productivity. The BioProcess Institute specializes in streamlining management of both the people and the process. Our role as management consultants allows us to take over some of the necessary but time-consuming tasks which are part of managing every business, but which managers rarely have time for. For example, we evaluate maintenance programs to preserve the engineering intent in a cost-effective way, and apply predictive maintenance where possible. We also provide project portfolio analysis to support budget and staff planning, with a keen focus on how to:

  • determine the right projects to do;
  • determine the real cost/budget for the portfolio; and
  • effectively manage even smaller projects (under $100k).

Similar to our BIOPROCESS ENGINEERING consulting services, our OPERATIONS MANAGEMENT consulting services provide our clients with help maintaining robust, compliant and sustainable systems and facilities; system and equipment evaluations; maintenance program evaluations; and help balancing the cost vs. risk involved with cGMP, safety and environmental regulation compliance.

OPERATIONS MANAGEMENT CONSULTING AT-A-GLANCE

  • Staff Consensus Facilitator
  • Cost of Change
  • Facility Reviews
  • Project Justification
  • Single-Use Component Information
  • Management Systems
  • Expert Witness
  • Third Party Opinion Leader
  • Arbitration
  • Facilitation
  • Vendor Relations

Training Video Project

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
The BioProcess Institute’s mission is to help people make better drugs. cGMPs play an important role in this for all of us.

During the 1960s, in the immediate aftermath of the thalidomide tragedy in Europe, the U.S. Food and Drug Administration issued Current Good Manufacturing Practices (cGMPs). Thanks to FDA drug reviewer Frances Kelsey, thalidomide was never allowed to reach the U.S. market. Her heroic blockage of the drug, combined with the failure of Europe to do so, led to the creation of cGMPs. These are the minimum requirements that manufacturers of pharmaceuticals (human and animal), food, processed tissues, dietary supplements, and medical devices must follow so that the products have the safety, identity, strength, purity and quality that they purport to have.

For good reason, cGMP regulations within the bioprocess industry are all-encompassing, complicated, and often times challenging to comply with. Conforming to them can be necessarily rigorous. While it is possible that failure to conform can quickly lead to a company’s demise, it is also true that committing too many management and QA/QC resources to covering the necessary bases can also immobilize productivity and growth. The key is to find the correct balance between satisfying cGMP requirements while maintaining your company’s ability to thrive and succeed. We are experts at finding that balance by zeroing in on problem areas quickly, precisely, and strategically to defuse the risks without neutralizing productivity.

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 without wasting your valuable company resources. We are adept at providing the right amount of direction and skilled guidance, without overstaying our welcome.

cGMP CONSULTING AT-A-GLANCE

  • Change Control Strategy, Implementation and Close-out
  • Technical Investigations
  • Regulatory Investigations
  • Subject Matter Expert (SME)
  • Project Justification
  • Single-Use Component Information Management Systems
  • Standards and SOP Development
  • cGMP Risk Assessment
  • Environmental Monitoring
  • Root Cause Investigation
  • NC/CAPA Support
  • EMEA/FDA/ISPE Expertise
  • FDA 483 Remediation Expertise
  • Mock Auditing and Audit Coaching