FEATURED ARTICLES

• IPS Recognized For Its Contribution To United Therapeutics Facility In Maryland

  Learn about United Therapeutics winning the Social Impact category for the 2020 ISPE Facility of the Year Award:

• IPS Announces Commitment To Employees During COVID-19 Crisis

  IPS-Integrated Project Services, LLC, a leading provider of engineering, procurement, construction management, and validation (EPCMV) services, announces an employee retention plan that secures jobs for their entire global staff, nearly 1,400 employees.

• IPS Announces New Office In Cherry Hill, NJ For Pharma, Cell / Gene / Bio Clients

  IPS-Integrated Project Services, LLC, a leading provider of Engineering, Procurement, Construction Management and Commissioning, Qualification, and Validation (EPCM/CQV) services, announces the continued expansion in the Americas region with the opening of a new office located in Cherry Hill, New Jersey.

• IPS Launches End-To-End Integrated Operational Readiness Compliance Solution For Cell And Gene Therapy Facilities

  IPS-Integrated Project Services, LLC, a leading provider of consulting, architecture, engineering, construction management, and CGMP compliance services, announces the launch of CarTon, an end-to-end integrated operational readiness compliance solution for cell and gene therapy facilities.

• What Cell and Gene Companies Need To Know About Leasing Space

  One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

• IPS Establishes Germantown, Maryland Facility To Serve Biopharma Industry Needs

  IPS-Integrated Project Services, LLC, a leading provider of Engineering, Procurement, Construction Management and Validation (EPCMV) services, announces the continued expansion in the Americas with the opening of a new office located in Germantown, Maryland.

• Overcoming The Unique Filling Challenges Of Autologous Therapies

  Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

• IPS Provides Engineering Solutions To BWXT For The Development And Commercialization Of Diagnostic Medical Isotopes

  IPS-Integrated Project Services, ULC, a leading provider of Engineering, Procurement, Construction Administration and Validation (EPCAV) services, was selected by BWXT ITG Canada, Inc. to provide Basis of Design and Detailed Design for BWX Technologies, Inc.'s (BWXT) isotope project, specifically the expansion of their medical isotope and radiopharmaceutical facility in Ottawa, Ontario, Canada.

• IPS To Design New Nexus Pharmaceuticals Manufacturing Facility In Wisconsin

  Nexus Pharmaceuticals Inc., a woman-owned, privately held, US-based healthcare company, announced recently an agreement with the village of Pleasant Prairie, Wisconsin to build an industry-leading sterile injectable manufacturing facility.

• Lupin Project Wins ENR Global Best Project Award Of Merit: Manufacturing

  ENR's Global Best Projects identifies and honors the project teams behind outstanding design and construction efforts of the past year. They received a record number of entries produces a diverse set of projects located in 20 countries that focused on safety performance, innovations, challenges, and design and construction quality - with a special emphasis on the diversity of global project teams and their collaboration.

• IPS Showcases INNOPHEX And Pharma 4.0 At Their Annual Technologies Tours At INTERPHEX

  IPS-Integrated Project Services, LLC (IPS), a leading provider of Engineering, Procurement, Construction Management and Validation (EPCMV) services, announces the ninth annual IPS Technologies Tours at INTERPHEX with Tours focused on the hottest trends in the industry, including Pharma 4.0 concepts, cell processing, and gene therapy.

   

• Dos & Don’ts Of Bioprocess Facility Construction

  Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the sixth in a six-part series on how single-use systems (SUS) are changing the modern biotechnology facility design and construction paradigm.

• Cell Therapy: Process Design Considerations To Support Commercialization

  Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

• Designing The Cell Therapy Facility Of The Future

  In 1931, Swiss doctor Paul Niehans injected a preparation of live cells from a parathyroid gland into a dying patient. The patient subsequently recovered, and Dr. Niehans had a eureka moment — that injections of living cells can have tremendous therapeutic value.

• A Checklist For Engineering Due Diligence In Pharma M&As

  Pharmaceutical plants cannot be treated like real estate. Instead, they require a detailed assessment of where they are in “operational compliance and production readiness.”

• Biocontainment: An Introduction To Control Levels & Practical Design Concepts

  In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.

• Bioprocess Facility Design — Layout Rules And Configurations

  Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

• An Introduction To Biopharmaceutical Facility Design & Layout

  This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

• Single-Use Systems For Aseptic Fill/Finish

  Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills

• Considering Options And Alternatives For The Design Of Complex Biopharma Facilities

  The movement of viral vectors, cell therapies and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skill sets can help you maintain the right balance in your facility design to maintain flexibility which is essential to meet diverse processing needs for biopharmaceutical manufacturing.