When it comes to consumer safety, the current regulatory environment has changed the pharmaceutical industry’s quality assurance landscape. With recent developments in international regulation, increased competition, cost constraints, demands for efficiency, supply chain complexity, and product/process complexity, pharma companies are consistently focusing on manufacturing and delivering zero-defect products. However, while expanding their global market footprint, organizations often struggle to ensure compliance with multiple countries’ regulations and requirements. IPS-Integrated Project Services, LLC is a leading provider of consulting, architecture, engineering, construction management, and CGMP compliance services, heavily focused on commissioning, qualification, and validation of facilities and pharmaceutical manufacturing systems. With the explosion of cell and gene therapy or advanced therapy medicinal products (ATMP), IPS has put a greater emphasis on helping the biopharmaceutical industry develop innovative business solutions, including the efficient qualification and validation of cell and gene therapy facilities and systems.
Cell and gene therapy is relatively new from a large-scale manufacturing standpoint, and it involves very complex biotechnological processes that incorporate both biological and aseptic manufacturing practices typically in the same manufacturing areas. IPS’ CarTon™ offers end-to- end integrated operational readiness and CQV compliance solutions for cell and gene therapy facilities from markets in the U.S. to the European Union.
CarTon is built to deliver a compliance solution that involves procedures, risk assessments, requirement documents and CQV protocols, standards, and facility design philosophies. The product helps startups with substantial medical and research experience but minimal biopharmaceutical manufacturing expertise get their facility up and running to produce products. Starting with a mission to help small biotech companies realize their vision, CarTon delivers a one-stop-shop for all the operating protocols and procedures.
Leveraging years of experience in design, construction, commissioning, qualification, and validation, IPS experts combine their technical and operational expertise to produce fully compliant commercial facilities and manufacturing operations. “Unlike other market players, we bring an engineering mindset to compliance and validation of aseptic and ATMP processes and facilities,” says Michael Westerman, Sr. Director of CQV Operations of IPS.
Since their founding over 30 years ago, IPS has supported thousands of companies in meeting their compliance and CQV goals, more recently helping nontraditional manufacturers. For instance, the company has helped a world-renowned children’s hospital in ensuring their new facility EU and U.S. compliant from a design and compliance/validation perspective. The client engaged two different companies to design and construct the facility that had less experience in the biopharmaceutical market and leaned on the focused expertise of IPS to assure both global compliance putting them on the path to manufacturing ATMPs onsite for treating children with cancer in their hospital. Through planning, compliance consulting, and full CQV services, IPS facilitated the lifesaving the ability to manufacture life saving onsite ATMP medicines for children being treated at the hospital. In another case, acting as the go-to compliance services provider, IPS helped a large research hospital in meeting U.S. government- funded operational and compliance needs from CQV through compliant quality system development for manufacturing.
IPS is currently working on multiple COVID-19 projects throughout the world supporting a plethora of different innovative technologies. A notable project currently in design involves integrated engineering, design, procurement, construction, and validation of a new formulation and filling facility for a COVID-19 live virus vaccine. The project is under a very specific and tight timeline. IPS is responsible for the entire EPCMV delivery of the project based on their reputation and knowledge as one of the largest and most skilled service providers to the biopharmaceutical industry.
With many success stories and dedication to their clients’ success, IPS evolved from a small company with less than 200 people to over 1400 people while expanding its global footprint. The company has grown drastically over a few short years and brought globally recognized talent and experts to the team, focusing on the cell and gene therapy space. The engineering, construction, and compliance divisions concentrate on developing their knowledge base to support an ever-growing list of clientele. IPS is currently taking new diversity initiatives, supporting women in biopharma, and changing the pharmaceutical industry by sharing internal knowledge amongst various teams. “With our processes and expertise, we design mentoring programs and succession planning to develop the next generation of leaders to expand technical skills required to support our global clients,” says Westerman.
Building strategic partnerships with large global biopharma companies with huge capital spend, the company also helps clients renovate old technologies and introduce new ones while developing new products.