The evolution of therapeutic modalities drives the adoption of single-use technologies.

Review of SUT Adoption in Biopharma Manufacturing

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

 Automating the Future of Fill/Finish

Topic

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

Videos

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

Manufacturing Intelligence: AI Integration in Pharmaceutical Lifecycle Management

Wilber Cruz is senior QC Microbiology manager at Abzena.

Wilbur Hightower is senior director, head of Site Quality at Abzena.

Vaishali Shah is previously head of Site Quality at Abzena.

Articles

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

Joseph Zeleznik is technical product director, IMCD US

Sydney Badger is a Technical Development Manager at IMCD. With over seven years of experience in the pharmaceutical excipient industry, Sydney has a strong background in oral solid dosage forms and formulation development. Leveraging her previous experience as an R&D formulator, she brings application-oriented technical expertise to her current role.

Dr. Manish Ghimire is the Director of Technical Development – North America at IMCD. Manish brings over 20 years of experience in pharmaceutical R&D and technical marketing, with deep expertise in solid dosage forms and advanced formulation strategies. He is a recognized thought leader known for translating complex scientific concepts into practical, commercially relevant solutions.

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Excipient Selection Strategies to Mitigate Nitrosamine Risks

Malav Parikh is director, Quality Risk Management, Global Quality Compliance and Systems, Takeda.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions. 

Techniques for Securing the Supply Chain and Combating Counterfeit Medicines

Gina Marsee is the Director, Compendial Compliance and Advocacy at Merck located in West Point, PA, USA. She holds a bachelor’s degree in Chemistry & Biology from the University of Tennessee and has worked in the pharmaceutical industry for 30+ years holding various leadership roles within Quality, Compliance, and Regulatory Affairs.

Katherine Ulman is the owner and Primary for KLU Consulting, LLC.She retired from Dow Corning Corporation after more than 40 years of employment.While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.

Joseph Zeleznik is Technical Director, North America for IMCD US and is also a member of IPEC-Americas’ Executive Committee, currently serving as Immediate Past Chair.

Candy Reynolds Cummings spent 15 years at GlaxoSmithKline starting as an analytical chemist and working up to QA Validation Manager in the OTC area (specifically oral care). Currently working at Evonik as the Regulatory and Product Stewardship Manager supporting the business line Silica for regulations in US, Canada, and Mexico.

Corporate Regulatory Affairs, ROQUETTE AMERICAS, INC.
Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products.She is currently President of the IPEC Federation and the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization.

Bob Sulouff is Sr. Manager Regulatory Affairs, Health & Pharma Solutions, ROQUETTE Americas. Bob has over 25 years’ experience in Regulatory Affairs and Quality, primarily focused on excipients. He is a member of Roquette’s Health and Pharma Solutions Regulatory team, where he advocates for value added pharma regulatory solutions.

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

This article details what co-processed excipients are and how they are made.

Co-Processed Excipients: Practical Engineered Solutions for Modern Pharmaceutical Challenges

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

PharmTech Weekly Roundup - April 3, 2026

Melanie Cerullo is chief quality officer at Kindeva.

Contract development and manufacturing organizations can assist sponsor company is ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

Is Your Annex 1 Strategy a Static Document or a Dynamic Defense?

Pascal Piedbois, Chief Medical Officer, One2Treat

FDA’s Project Optimus shifts oncology dosing from MTD to balancing efficacy and safety via metrics like Net Treatment Benefit to pick doses.

From Data to Insights: Using the Totality of Evidence for Better Oncology Dose Selection

Akanksha Prasad, MS, is a chemical and bioprocess engineer with over nine years of experience in chemical, biologics, and pharmaceutical process development. Her expertise spans mRNA, vaccines, and biologics, with a focus on technology transfer, PAT, scale-up, purification, and regulatory compliance. She holds a Master’s in Chemical Engineering with a biopharma specialization from the Illinois Institute of Technology, Chicago, and a Bachelor’s in Chemical Engineering from India.

This article explores key engineering strategies that support this transformation, including hybrid reactor design, clean-in-place optimization, automation architecture, and modular scalability. 

Engineering Advanced Pharmaceutical Processes: Design, Control, and Risk Reduction

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions. 