Business Solutions

The application of Microbiology to the biopharmaceutical space requires the technical foundation of a well-trained scientist alongside the perfectly matched international experience of an industry professional. Ranging from technical procedure and report writing to the creation of critical programs, such as Method validation or Microbial Investigations, we can carefully lead the entire process from development through implementation.

When more specific, hands-on microbiological skills are needed, such as aseptic techniques, dilutions and pipetting, or sanitization practices, we can also work with your analysts to understand, learn, and become skilled in these fundamentals.

Maybe you need to curate the appropriate strategy for key microbiological processes such as incubation schemes, growth promotion parameters, or microbial identification? Let us guide your microbiologists through this very important strategy work and help position your company on top.

Managing a QC laboratory requires both the right energy and placing that energy into the right people. VVF Science can evaluate how your laboratory operations and management controls are functioning and determine opportunities for growth. We can also advise on new materials, equipment, or methodologies that are needed in your lab as well as execute a wholescale assessment of laboratory design and layout. These evaluations can reveal concrete ways to optimize workflow, increase productivity, and improve operational efficiency—while also preventing sample mix-ups or contamination.

Managing a lab is not complete without the appropriate documentation and data management programs, quality metrics and reporting, and a strong quality culture. Let us partner with you to develop the correct approach for your lab and your goals.

Vanessa understands precisely where and how microbial science intersects with the business of pharmaceutical manufacturing and global public health. With this knowledge, VVF Science skillfully performs comprehensive internal and external audits and delivers detailed – and actionable – major systems quality and manufacturing assessments, generation trend reports, and quality metrics.

A discrete event with a singular purpose: to evaluate a specific system, process or methodology and provide a comprehensive perspective on your state of compliance. Audits and assessments can do just that, curated to the exact needs of your company or organization.

Whether it’s an internal review of a laboratory or aseptic manufacturing areas or an external evaluation of third-party vendors, VVF Science will ensure you are covered. We provide an up-front consultation to scope the needs and applicable standards, and after the assessment, we deliver a tangible and measurable report with actions designed to bring change to an organization. We can also perform due diligence for company mergers and acquisitions, technical assessments for all types of manufacturing, and retrospective reviews of products or investigations.

A program plus collaboration ensures a successful drug product:

Sterility Assurance is an elegant technical term that collectively represents the elements needed to ensure sterility is designed into a drug product. Let VVF guide you through the development of these critical programs, from facility design and environmental monitoring to contamination control strategies and cleanroom controls.

We can also design, implement, and help you manage an Aseptic Process Simulation program that meets the specific needs of your product and process. Don’t let gown qualification, aseptic training for techniques and behaviors, or understanding air flow pattern studies overwhelm your organization.
We are here to curate these programs for you at just the right technical standard.

Or, maybe you are far enough into a sterility assurance program, but would like support in measuring its performance? VVF Science can create streamlined and value-added trending reports for your Product, Environment, and Utilities programs.

Experience matters most when it comes to interfacing with regulatory agencies from across the globe. Understanding the role in which microbiology plays in each phase of a company’s regulatory journey is vital. From initial product development, registration, and filing of microbial data all the way through to sustaining commercial operations, we can confidently lead the way.

Depending on where you are in your product’s lifecycle, VVF Science can also support the regulatory inspection process, including initial preparation of your facility and hands-on management of day-to-day inspection as well as all post-inspection follow-up. Maybe you need to develop a custom regulatory strategy and response to inspection observations? Let VVF integrate with your operations and support this highly intense yet critical process.

VVF Science is committed to bringing together people, building community, and promoting STEM throughout the life sciences industry. We support all types of outreach opportunities in academia, industry, and the general public.

Vanessa speaks regularly at technical conferences in the pharma & biotechnology space, to students at the university level, and often leads webinars on critical topics. With strong technical writing and communication skills, she has authored first-in-kind guidance documents, industry book chapters, and blog posts that all demonstrate value, reinforce best practices, and/or teach principles of microbiology.