With the rate of new drug approvals on the rise, clients have made major strides in increasing productivity while also responding to revised regulations to better protect manufacturers. Pharmaceutical companies continue to invest in both new and existing facilities and have identified biotechnology as a targeted, emerging industry.

As the largest professional services provider to the biopharmaceutical industry, clients benefit from both our local presence and global reach. Jacobs offers a range of services from advanced planning and programming to design, construction, and commissioning to startup, qualification, and validation which allows us to help clients face challenges and identify opportunities throughout a project's life cycle.

Jacobs' Facility of the Future concept integrates modular design, offsite fabrication, and high-efficiency processes to provide new, cost-effective facilities. We are currently incorporating innovative processes for a key client, including single-use bioreactors and cell culture manufacturing devices that are disposed of after one use, reducing maintenance costs, minimizing the risk of cross contamination, and cutting the need for costly sterilization systems.

In the fast-moving, pharmaceutical and biotechnology industry, clients look to facility design experts to provide a competitive edge. Jacobs' methods involve collaborative planning from the project's conception. Modern research campuses, today, feature libraries, auditoriums, and day care centers; but more importantly they include flexible laboratories, natural light, and gathering places to promote collaboration, creativity, and interaction.

From proactive design and engineering to construction management, and modular construction services, Jacobs supports institutional, industrial, commercial, and government clients. We take the time to understand the client's needs and use our own proven practices and experiences to deliver project success and sustain long-term relationships.

Jacobs projects are internationally recognized and often set the standard for innovation. Together with clients, we are the recipients of 12 International Society of Pharmaceutical Engineers (ISPE) Facility of the Year Awards; an honor given to those who make a significant impact on the future of the pharmaceutical industry.

Clients priorities in bulk manufacturing include issues such as product integrity, platform flexibility, speed to market, capital effectiveness, design innovation, lean project delivery, and low cost/high reliability. Understanding and integrating these priorities into the project execution plan from the outset is key to our success in this industry.

Jacobs' bulk biological experience spans from the U.S. to emerging markets across the world. With a global network of experts we can quickly find the right person who understands evolving trends, such as single use technology, shared facilities, lean manufacturing, and modularization.

Jacobs provides professional services on all scales of biopharma development and commercial manufacturing from small revamp projects to major bulk facilities. We design for a variety of biological processes including cell culture, fermentation, purification, and all downstream operations. Some designs are single product specific while others are multi-product and multi-purpose with the necessary attributes of flexibility and adaptability for sustained long-term use.

Complex regulatory changes and new secondary manufacturing developments require a thorough understanding of areas such as isolation technology, lean manufacturing, containment, and automation. Clients need a partner whom they can trust with experience to advise and recommend solutions.

Jacobs' broad experience spans the filling technology spectrum – common elements such as formulation, fill, inspection, packaging, component preparation, equipment wash and preparation, and locker/gowning arrangements. Familiarity with all types of sterile filling facilities allows us to help clients evaluate their options – for example, renovate existing operations or design major greenfield components of a new campus.

To avoid disruption of current operations, Jacobs phases construction and develops roadmaps that anticipate project needs, content and functionality that allows for peer facility metric comparison and cost benchmarking. The results are award-winning facilities that produce liquid, lyophilized and powder product in most final dosage forms including vial, cartridge, syringe, and novel delivery devices.

Delivering projects for pharmaceutical and biotechnology pacesetters and emerging leaders globally, Jacobs has been providing commissioning, qualification and validation (CQV) services to our clients for nearly 40 years. Our dedicated CQV personnel bring in-depth knowledge of industry regulations and provide expertise on conventional and emerging technologies.

In addition to performing standalone CQV, our integrated approach to project delivery includes engineering, procurement and construction management. Our design, construction and CQV team members collaborate together to develop right-sized, integrated strategies that result in efficient and compliant project delivery. By providing end-to-end project solutions, we help ensure that our clients’ facilities and assets are production-ready in the shortest time possible, with an emphasis on safety, operational reliability and capital expenditure savings.

CQV Services:

• CQV Master Planning
• Requirements Development
• Risk Assessments
• Design Review and Qualification
• Factory & Site Acceptance Testing
• Start-up & Commissioning
• Qualification
• Cleaning & Sterilization Validation
• Process Validation
• Maintenance & Reliability
• Serialization
• SOP Development
• Personnel Training
• CAPA & Change Management
• Environmental Monitoring
• Temperature Monitoring
• Compliance Gap Analysis
• Quality System Auditing
• Data Integrity