Drug Digest: Reshoring Manufacturing and Securing Cold-Chain Supply for Biopharma

In this episode of BioPharm Drug Digest, Thani Jambulingam, PhD, professor in the Department of Food, Pharma, and Healthcare at St. Joseph’s University, Ryan Last, JD, associate at Troutman Pepper Locke, and Jeffrey Heil, PE, director of process technology and process engineering SME at Arcadis, discuss how biopharmaceutical manufacturers are building a more resilient domestic supply chain, from reshoring manufacturing to securing cold chain infrastructure for biologics and cell and gene therapies (CGTs).

Last cites BioPlan Associates’ 2025 survey showing only 17.4% of companies keep 100% of CGT manufacturing in house, down from 30% last year.¹ “Outsourcing and reshoring are not opposites,” he says, as much outsourcing is shifting to US-based contract manufacturers. Dr Jambulingam adds that trade policy uncertainty is moving companies from cost-driven to risk-adjusted supply chain decisions.

Where do the biggest capacity gaps remain?

Heil says modular manufacturing helps de-risk construction amid labor shortages and lets companies reuse designs across facilities. Last identifies fill/finish as the narrowest choke point, with lead times of 18 to 30 months despite more than $5 billion in announced investment since 2022.²

On cold chain, Heil notes newer modalities require stricter temperature control, while Dr Jambulingam describes an evolution from preservation to monitoring to prediction and intervention, using ultra-low temperature storage, validated routes, sensors, and predictive analytics. Last adds that the Drug Supply Chain Security Act requires electronic, package-level traceability, which FDA now inspects during facility audits.

A resilient supply chain is not necessarily 100% domestic but rather “diversified but anchored,” Last says. Dr Jambulingam recommends domestic capacity for strategic products, geographic diversification, flexible manufacturing, end-to-end visibility, and redundancy in critical materials, fill/finish capacity, and logistics.

Interview featuring

Thani Jambulingam, PhD, Professor, Department of Food, Pharma, and Healthcare, St. Joseph’s University

Dr Jambulingam is a highly respected professor who brings his award-winning research into the classroom and demonstrates how pharmaceutical supply chains are instrumental to a company's success. Outside of the classroom, Dr Jambulingam is a reviewer for pharmacy journals (Annals of Pharmacotherapy and American Journal of Managed Care Pharmacy) and an ad hoc reviewer for marketing and management journals (Journal of Marketing, and Journal of Business Venturing).

Ryan Last, JD, Associate, Troutman Pepper Locke

Last provides comprehensive corporate advisory and transactional services to a diverse range of domestic and international clients, including those in the entertainment, financial services, venture capital, private equity, energy, insurance, consumer products, and retail sectors. With a background as vice president at Nomura, he brings a deep understanding of the regulatory landscape, offering clients advice on legal and compliance matters and product development. This includes corporate governance, contractual matters, mergers and acquisitions, capital market transactions, fund formation, US Securities and Exchange Commission filings, and more.

Jeffrey Heil, PE, Director Process Technology and Process Engineering SME, Arcadis

Heil has more than 20 years of experience supporting life sciences, specialty chemical, and industrial manufacturing programs. His work focuses on synthetic chemistry, potent compound, antibody-drug conjugate, and multiproduct facilities where process safety, containment, operability, and technical assurance must be integrated early in design. Heil partners with owners, operations teams, and design engineers to translate process risk into practical facility solutions. He is active in industry technical communities and contributes to guidance, knowledge sharing, and mentoring across emerging manufacturing platforms.

Sponsors

This episode of Drug Digest is sponsored by:

• FUJIFILM Biotechnologies

About BioPharm Drug Digest

Drug Digest is a video series with the BioPharm International® editors, who conduct in-depth interviews with industry experts around the latest research and pipeline developments as well as emerging opportunities, obstacles, and advances in the biopharmaceutical industry related to the manufacturing, distribution, supply, and regulatory compliance of bio/pharmaceutical products.

*No upcoming episodes for the remainder of 2026

References

1. BioPlan Associates. 2025 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. BioPlan Associates; April 2025. Accessed October 28, 2026. https://www.bioplanassociates.com/22nd/
2. Sharma R. Pharmaceutical sterile fill-finish market. Dataintelo. Updated April 2026. Accessed October 28, 2026. https://dataintelo.com/report/global-pharmaceutical-sterile-fill-finish-market