Biomanufacturing capacity optionality

Sponsored by: Cytiva

Focused on:

  • Biomanufacturing Manufacturing Solutions

Date: 15 December


Time: 4PM London / 8AM California

Considerations when evaluating biomanufacturing expansion planning

A recent BioPlan survey, reported that more than 50 percent of biomanufacturers expect to experience moderate to serve commercial scale capacity constraints by 2025. With thousands of clinical trials underway, and growing pressures to support new vaccines and therapeutics for SARS COVID -19, the gap in manufacturing capacity will certainly increase rapidly. Critical assessments are needed for the various manufacturing options that can offer flexibility, speed and confidence needed to respond to critical shortages.

Long wait times and potential loss of intellectual property at contract manufacturing sites have led many biomanufacturers to explore their own manufacturing facility and platform prospects. The various options for addressing biomanufacturing capacity span from greenfield construction of an entire campus to retrofitting and existing site to modular solutions. The best fit must be imperially determined from analysis of the unique business strategy. Opportunities to include standard design and manufacturing platforms can offer distinct advantages and de-risk investments.

Five subject matter experts who have extensive experience designing and installing a wide assortment of biomanufacturing solutions across the globe will discuss the pros and cons of the different biomanufacturing facilities and platform choices that exist. Join for a pragmatic assessment of your options to efficiently build or retrofit to meet your business needs now and into the future.

Presented by

Joe Makowiecki ,

Director of Business Development Enterprise Solutions, Cytiva

Joe has been in the Bioprocess industry for 25 years and has held management, senior management and director positions within Process Development, Pilot Plant, cGMP Manufacturing and Enterprise Solutions organizations. As Cytiva’s Director of Business Development for Enterprise Solutions, his responsibilities include product management of the FlexFactory (single-use, flexible and deployable biomanufacturing platforms), strategy for both the FlexFactory and KUBio (modular facility solutions) offerings, new technology identification and integration and commercial activation.

Joe’s expertise and experience includes downstream process development, scale up, cGMP manufacturing, process technical transfer, manufacturing site operations, contract manufacturing services, bioprocess solution selling and business development. He has been involved with the development, technical transfer, scale-up and manufacture of multiple diagnostic, vaccine and bio therapeutic products from mammalian, microbial and insect expression systems.

Steve Gravallese,

Program Director, Enterprise Solutions, Cytiva

Steve has 34 years of experience in the design, construction, commissioning, qualification and operation of biologics, pharmaceutical, and chemical facilities in the US, Europe, and Asia. He has supported over $1billion in capital projects since 2001 in the life sciences industry and has managed a portfolio of $300million in capital investments from project establishment through regulatory licensure.

As Program Director at Cytiva he is responsible for the development, design, and execution of the KUBioTM box modular biomanufacturing program for different modalities such as mAbs, viral vectors, plasmids, etc. He was also the founding technical creator of the BioPark biomanufacturing campus Program and has also managed strategic relationships with engineering and modular partners. Steve has an extensive process and project engineering background which augments his expertise in the development of GMP facilities through product licensure.

Carol Houts,

VP Quality and Regulatory, Germfree

Carol Houts is the Vice President of Quality and Regulatory for Germfree, an offsite clean room construction company that provides facility solutions for biopharmaceutical applications. Carol is an executive with over 25 years’ experience in pharmaceutical, and biologics product development, quality, regulatory affairs and clinical research. Carol has worked intensively to have constructive and cooperative interactions with the FDA and other global regulatory agencies through formal meetings, regulatory submissions, inspections and compliance remediation projects. Prior to joining Germfree Carol has worked extensively to build companies organizational and service capabilities to increase revenue and sustain long-term growth. Carol has led business development activities to achieve funding, and developed business plans for demonstrating investment opportunities.

Noel Maestre,

SlateXpace Director

Noel Maestre is a Biotech Core Team leader at CRB, with an emphasis on Advanced Therapy Medicinal Products (ATMPs). Noel comes from an extensive background in mechanical and process utilities engineering with experience in the life science industry.). Noel specializes in the design, construction and startup of biotechnology, pharmaceutical and advanced technology facilities, and has emerged as a cell and gene therapy Subject Matter Expert. Maestre is experienced in traditional biotechnology/pharmaceutical facility design, including a concentration on single-use process systems, batch versus continuous process and emerging technologies, such as cell and gene therapy. His focus as a project manager is to provide the right solution for the specific problem—true turnkey delivery, lean concepts and innovative project execution are key goals when delivering projects. Maestre is a graduate of Pennsylvania State University with a Bachelor of Science in mechanical engineering.

James Bornholdt,

JP Bornholdt is licensed as both an architect and professional engineer at CRB. He specializes in facility planning, process architecture, and project management for advanced life science facilities, with an emphasis on Advanced Therapy Medicinal Products (ATMPs). His experience encompasses facility design for biotech and pharma, domestic and international current Good Manufacturing Practice (cGMP) regulations, process design and development, project management, HVAC design, advanced energy modeling, and construction administration. JP's expert knowledge of multiple disciplines provides a strong basis for integrated facility design. His ability to conceptualize and communicate these ideas in real time is valued by the clients he serves.

Key Learning Objectives

  • Understand your options for building from greenfield, retrofitting an existing facility or utilizing modular biomanufacturing environments
  • Increase awareness of the benefits of a standard design in biomanufacturing
  • Explore modular facility options at different biomanufacturing scales
  • Gain an appreciation for a configurable single-use manufacturing platforms for biomanufacturing


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