Off Script: A Pharma Manufacturing Podcast

Off Script: A Pharma Manufacturing Podcast

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!

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Jaksot(129)

Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part Two

Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part Two

As pharmaceutical manufacturers push forward with massive capital expansion plans, challenges go beyond simply breaking ground on new facilities—it’s also managing the growing complexity, uncertainty,...

12 Touko 19min

Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part One

Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part One

Rising capital investment in pharmaceutical manufacturing is pushing projects to unprecedented scale, but execution strategies haven’t fully kept pace. As companies commit billions to new facilities t...

5 Touko 31min

Annex 1 and the Shift to Proactive Sterile Manufacturing

Annex 1 and the Shift to Proactive Sterile Manufacturing

Ever since the revised Annex 1 was published, drug makers have been navigating a broader transformation of sterile manufacturing that extends beyond compliance. Contamination control, in turn, is beco...

28 Huhti 25min

How U.S. Policy Is Reshaping Pharma Outsourcing

How U.S. Policy Is Reshaping Pharma Outsourcing

As the U.S. government pushes to reshore pharmaceutical manufacturing and rein in drug pricing, the implications for CDMOs and the broader outsourcing ecosystem are coming into sharper focus. While la...

21 Huhti 30min

Building the Foundation for Autonomous Bioprocessing

Building the Foundation for Autonomous Bioprocessing

While fully autonomous bioprocessing is within reach, adoption remains gradual as manufacturers navigate challenges around data maturity, regulatory expectations, and operational readiness. As compani...

14 Huhti 22min

Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply

Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply

Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (...

7 Huhti 16min

Engineering the Next Generation of ADCs

Engineering the Next Generation of ADCs

Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pip...

31 Maalis 20min

Automating Cell and Gene Therapy Manufacturing for Scale

Automating Cell and Gene Therapy Manufacturing for Scale

Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production proce...

24 Maalis 23min

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