In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.
Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.
Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.
In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.
Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.
Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.
In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.
Stuart Tindal and David Chau discuss spectroscopic sensor selection for continuous bioprocessing and how industry collaboration drives shared innovation.
Richard Sanderson, IPS, discusses pharma capital project cost pressures, bloated deliverable lists, and making the case for EPCM's end-to-end delivery model.
At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption.
Leslie Weaver and George Hunt, IPS, discuss early sustainability and lean alignment in pharma construction that reduce costs, absorb disruptions, and keep projects on schedule.
At INTERPHEX 2026, Bryan Poltilove highlights a novel technology as a promising point-of-use media manufacturing approach with major sustainability and logistical benefits.
At INTERPHEX 2026, George Kwiecinski examines FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.
Ryan Kelly, Rx360, explains how third-party audits and integrated quality-supply chain strategies protect pharma supply chains and patient safety.
At INTERPHEX 2026, David Chau and Stuart Tindal discuss automation, single-use durability challenges, and the shift to predictive control in continuous bioprocessing.
The industry is feeling the push to modernize facilities and manufacturing processes.
At INTERPHEX 2026, Bethany Silva, Jason Pennington, and Mel Radford discuss how smart sensors, connectivity, and advanced analytics are enabling predictive, insight-driven pharma manufacturing.
Avi Nandi, SK Pharmteco, explains at INTERPHEX 2026 how CDMOs simplify cell & gene therapy supply chains by managing lead times, consistency, and material expiry.
At INTERPHEX 2026, MasterControl CEO Dave Edwards details how AI tools are boosting efficiency and compliance in pharma quality and manufacturing without replacing human oversight.
Maria Batalha, Valgenesis, discusses how her team assited a comapny in centralizing drug substance data, standardize processes, and unlock powerful AI-driven insights.
Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.
At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.
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The CDMO landscape is shifting toward long-term strategic partnerships as drug modalities grow more complex and supply chain pressures mount. Noritsugu Fujita, Division President of Pharmaceutical Solutions Division at Terumo, explains how an integrated, single-source model for parenteral drug development aims to streamline the path to a patient-ready product.
Drug shortages are rising. Learn what's breaking the pharmaceutical supply chain, and what industry leaders are doing to fix it.
Ranjit Deshmukh, Principal, BiologixCMC, discusses how contract manufacturers can optimize their processes and plan for the future by optimizing facility design.
This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.
In this clip from episode 1 of Manufacturing Intelligence, Richard Jaenisch of Open Biopharma discusses uses of AI for deviations and investigations in pharma.
In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.
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Peter Belden, Tjoapack, discusses how the rise of specialized medicines for smaller patient populations is necessitating more flexible, redundant packaging capacity to manage complex global distribution requirements.
