Susan Haigney

PharmTech Weekly Roundup—September 18, 2026

, artificial intelligence was analyzed as it is used in formulation labs, risk files, and quality systems, while conference season put quality culture and audit rigor back in the spotlight. Meanwhile, manufacturers kept reshaping where and how they make things, from portfolio divestments to new spray drying capacity.

 will review CMC, pharm/tox, and clinical components on a rolling basis before formal submission, with Acting Commissioner Kyle Diamantas framing it as a bid to keep pace with China on early-stage drug development.

Hovione opened a new 31,000-square-foot spray drying facility in New Jersey

, which doubles its US capacity for turning poorly soluble compounds into amorphous solid dispersions within the same quality system as its drug substance operations.

Sanofi's divestment of 20 mature medicines and 3 manufacturing plants to Cheplapharm

, in exchange for a 26.4% equity stake, reflects a push to simplify the portfolio and free up capital for pipeline investment.

In conference coverage, after acquiring a San Diego sterile fill-finish site that promptly drew an FDA Form 483, PCI's B. Timothy Bassler told the PDA/FDA Joint Regulatory Conference in Washington, DC, that 

rigorous shop-floor oversight and clear escalation authority

 turned a Voluntary Action Indicated outcome into a rebuilt quality system.

Sanofi's Helen Motamen reminded the attendees at the PDA/FDA Joint Regulatory Conference that 

internal audits are patients' last line of defense

, built on independent, continuously qualified auditors and risk-based agendas rather than tenure alone.

AI in quality systems needs governance before technology

, warning that hallucination rates as high as 94% mean any surfaced findings must stay traceable and human reviewed.

Genentech's Lori Dingledine told the PDA/FDA conference that 

advanced therapy programs succeed or stall on raw material execution

, urging early vendor audits and dual sourcing to bridge the gap between research-grade and GMP materials.

And AbbVie's Karyn Campbell walked through 

2 audit case studies where incomplete corrective actions resurfaced at later inspections

, reinforcing her point that a CAPA is only as strong as the root cause investigation behind it.

In a preview of the upcoming CPHI Milan, Quotient Sciences’ 

Andrew Parker explained how AI-driven Bayesian optimization

 is helping formulators converge faster on a target profile, provided manufacturability is planned in from the earliest molecular design stage.

Parker's case for AI-enhanced adaptive dose titration

 shows how deferring dose-strength decisions until after early human data keeps formulation teams from wasting resources on stage-inappropriate development.

In expert commentary this week, Plarent Ymeri of Smarteeva makes the case that 

continuous, AI-assisted monitoring of complaint and post-market data

 could finally close the months-long lag between a rising failure signal and a formal risk file review, especially for dual-regulated combination products.

 Feliza Mirasol tracks 2026's rapid pivot from IV to subcutaneous biologics, where 

the FDA's July approval of a subcutaneous isatuximab formulation

 cut infusion reactions from 25% to 1.5% and is pushing CDMOs to expand fill-finish and device-assembly capacity.

This week's stories show that AI is only as good as the human governance and root-cause discipline built around it. For the full stories, visit 

Videos

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.

CPHI Milan 2026: Trends in Pharma

Tara Dougal, event director for Pharma at Informa Markets and head of 

, discussed how artificial intelligence (AI) and technology are reshaping the pharmaceutical industry across multiple fronts, along with a new sustainability-focused offering at this year's event.

Dougal noted that AI technology now touches nearly every part of the business, from manufacturing optimization and quality management to regulatory compliance and commercial decision-making. She highlighted specific areas seeing rapid change. Cold chain and logistics have grown more critical as supply chains handle increasingly complex networks along with a growing volume of temperature-sensitive products and advanced therapies. Contamination control remains foundational to product quality, patient safety, and compliance, with expectations around sterile manufacturing continuing to rise. Labeling is also evolving quickly, driven by serialization, track-and-trace requirements, anti-counterfeiting measures, and a broader push toward more sustainable solutions.

Building on that sustainability theme, Dougal announced the launch of a brand-new Sustainability Summit at this year's event. The paid conference will run on the first 2 days of the show and is designed to offer attendees a genuine deep dive into the biggest sustainability challenges facing pharma. It aims to bring together a targeted, high-value audience of professionals genuinely committed to driving better outcomes across the industry.

Dougal emphasized that while sustainability itself isn’t a new topic for pharma, this summit is meant to push the conversation past broad statements of ambition and into practical, actionable territory. The focus will be on what companies can actually do, what barriers stand in their way, what they can learn from one another, and how different parts of the supply chain can collaborate to drive real, actionable change.

Dougal’s remarks point to 2 connected trends shaping CPHI Milan in 2026: the accelerating role of AI and technology across manufacturing, compliance, and logistics, and a sharper, more action-oriented focus on sustainability as a core industry priority rather than an aspirational talking point.

Click the above video to watch the interview.

PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.

CPHI Milan 2026: AI and Bioavailability, Part 2

, Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, discusses about how artificial intelligence (AI) is being integrated into pharmaceutical formulation development.

Parker believes that AI adoption in formulation science is still in the early stages, with formulators still deciding how the technology can be used most effectively. AI is not replacing workers, assures Parker, but rather enhancing their ideas and helping to catalyze development within the constraints of a given formulation program. He stressed that human-in-the-loop evaluation remains essential, but AI may enable more efficient programs and help teams meet target profiles faster.

Flexibility built around adaptive dose titration is key. Parker explained that when a new therapeutic's solubility and bioavailability in humans aren’t yet well understood, Quotient Sciences’ Translational Pharmaceutics platform allows teams to avoid locking in dose strengths prematurely, deferring that decision until after the first human study. This de-risks development by not forcing commitments based on incomplete data.

He also emphasized the importance of horizontal integration between chemistry/CMC teams and clinical development teams. Rather than defaulting to commercially viable, long-shelf-life formulations, teams should ask what’s truly needed at each development stage to avoid wasting time, money, and effort generating redundant data for formulations that will never be used beyond an early-phase study.

Quotient Sciences can be found at Booth 6K73 at 

, which is occurring from October 6-8, 2026.

Click the video above to watch part 2 of this 2-part interview.

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.

Pipette adding fluid to one of several test tubes | Image Credit: ©motorolka -stock.adobe.com

As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequential and least standardized parts of the supply chain, according to speakers presenting at the 2026 PDA/FDA Joint Regulatory Conference during the Navigating Complexities of Raw Materials in the Manufacturing of Advanced Modalities session.

In her presentation, Aligning Raw Material Strategies with Global Regulatory Expectations, Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech,stressed that while guidance documents set direction, execution is where advanced therapy medicinal product (ATMP) programs succeed or stall.

Dingledine cautioned against treating ATMP raw material management the way large-molecule biologics have long been handled. There is complexity in the execution, and a large pharma company absorbing an asset through business development faces different practical challenges than a startup defining procedures for the first time. Health authorities, Dingledine argued, should be treated as collaborative partners rather than obstacles, a message that lands well when programs bring robust, data-backed justification to the table.

The FDA treats viral vectors as active drug substances and applies phase-appropriate current good manufacturing practice (CGMP) from early development, while the European Medicines Agency places starting-material compliance under sponsor responsibility, and the Pharmaceuticals and Medical Devices Agency in Japan and the Pharmaceutical Inspection Cooperation Scheme emphasize risk-based quality management and donor screening. Reconciling those expectations starts with clear categorization: starting materials (plasmids, viral vectors, master cell banks, leukapheresis material) versus raw and ancillary materials consumed during manufacturing but absent from the final product, such as research-use-only (RUO)-grade cytokines, growth factors, and single-use consumables.

That RUO-to-GMP gap was a central theme, echoing concerns raised elsewhere in 

 coverage of cell and gene therapy sourcing. As Alengo Nyamay'antu of Polyplus-transfection told 

Sourcing Success in Cell and Gene Therapy Development

, “Raw materials will need to be GMP-compliant for the drug product to reach commercialization, and their supply should be secured.”

 This is a principle the conference session translated into practice: early, deep-dive quality audits of research-grade vendors, dual sourcing where feasible, and formal quality agreements that define specifications and change-notification expectations.

Risk assessment ran through every section of the talk, aligning with the tiered, risk-based approach Fouad Atouf described 

Managing Risk for Biomanufacturing Raw Materials

 <1043> classifies materials from licensed, low-risk inputs up through high-risk research- and industrial-grade sources. The conference session urged sponsors to revisit risk assessments whenever product strategy shifts and to assign clear internal ownership for reviewing new vendor information.

Supply chain fragility, particularly single-source dependency and cold chain integrity, drew some of the most pointed guidance. A single point of failure can halt manufacturing outright, and temperature excursions during transit can destroy biological activity entirely. The presenter recommended continuous real-time temperature tracking and exclusive partnerships with qualified specialty biopharma couriers.

The session closed on the development-to-operations hand-off, where legacy suppliers inherited through acquisitions, thin quality systems at early-stage companies, and limited GMP experience can create traceability gaps just as programs approach process performance qualification. The fix, the presenter said, is unglamorous but essential: tight, continuous alignment between quality control, quality assurance, and regulatory teams, and global filing coordination so material changes don’t create supply gaps down the line.

Thomas F. Sourcing success in cell and gene therapy development. 

https://www.pharmtech.com/view/sourcing-success-cell-and-gene-therapy-development

Managing risk for biomanufacturing raw materials

September 6, 2017. https://www.pharmtech.com/view/managing-risk-biomanufacturing-raw-materials

Articles

Raw materials for cell and gene therapies are becoming a decisive constraint as programs transition from academic-scale methods to commercial manufacturing, with major variability across regulatory regions. Effective execution hinges on risk-based categorization and early alignment with health authorities using defensible data. Key fault lines include the RUO-to-GMP transition for cytokines, growth factors, and consumables; supply-chain fragility from single sourcing and cold-chain failures; and acquisition-driven traceability gaps at tech transfer. Durable readiness requires rigorous vendor oversight, quality agreements, and cross-functional global filing coordination.

Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.

Raw Material Complexities and Strategies with for Advanced Therapies

Quality inspector walking through processing area with stainless tanks and tablet | Image Credit: ©Surachai -stock.adobe.com

During the session, Internal Audits: From Strategic Planning to Effective Follow‑Up, moderated by Karyn M. Campbell Senior Director, QA Audit and Compliance, AbbVie, at the 

, speaker Helen Motamen, MS, global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, gave a presentation, titled “Planning and Executing the Internal Audit”, in which she emphasized the importance of performing internal audits.

“Someone will receive what you manufactured.” That single line anchored Motamen's presentation, which featured photographs of patients on the receiving end of manufactured products, a reminder that an internal audit isn’t a paperwork exercise. Internal audits are a direct line of defense between a shop floor and the person who ultimately takes the medicine, Motamen stressed.

Motamen framed audit risk in 3 dimensions (strategic, tactical, and operational) before turning to what she called the real drivers of a strong internal audit program: the team, the agenda, and how findings get delivered. Effective auditors, she said, combine rooted character traits (integrity, resourcefulness, persistence) with interpersonal skills (communication, curiosity, data-driven synthesis) and technical grounding in subject matter and regulatory requirements. Crucially, “auditors must have independence from the topic(s) being evaluated.” Qualification doesn't stop at onboarding, either. Motamen described a progression from initial training through continued, lifelong learning and, for some, external certification, explicitly rejecting tenure alone as a marker of readiness.

Team composition matters as much as individual skill. Motamen laid out the tradeoffs among internal auditors (institutional knowledge, cost efficiency), external auditors (independence, cross-industry pattern recognition), and cross-functional experts brought in for technical topics such as artificial intelligence (AI), machine learning, and visual inspection, with staffing strategy and backup plans decided well in advance.

On agenda design, Motamen's central point was that risk should drive time allocation rather than treating every system equally. A risk-based approach can help one prioritize where audit time and efforts, a principle Motamen extended to internal programs, weighing deviation trends, time since the last audit, staff turnover, and facility age. She also framed bottom-up (starting from records) and top-down (starting from system design) approaches as complementary rather than competing, with a mature agenda using both.

Delivery modality drew particular attention. Remote and hybrid audits are “no longer pandemic-era workarounds,” Motamen said, and can handle data-mining and some structured interviews effectively. But shop-floor time, gowning practices, and the texture of daily work still require an on-site presence, because, as she put it, “quality culture is an important leading indicator and is best sensed on-site.” A 2015 analysis on 

 similarly cautioned that culture is “difficult to quantify” through signatures or corrective actions and preventive actions (CAPA) statistics alone, reinforcing why Motamen leans on direct observation.

The session also addressed auditing AI-enabled systems. Motamen pointed to the European Medicines Agency’s and the FDA’s 

 plus a 2026 warning letter, as evidence that “regulations [are] forming” around this space.

“AI-assisted drafting requires the same quality controls as traditional document preparation”"

, a standard Motamen translated into concrete audit questions: data provenance, model version control, human-in-the-loop oversight, drift monitoring, and explainability.

Motamen closed by saying that well-qualified auditors, a risk-based agenda balancing structure and agility, and willingness to probe new technology are what turn internal audit into a genuine feedback loop, one that protects patients, ensures compliance, and drives quality culture.

 is happening from September 14-16, 2026 in Washington, DC.

Harrison A and Schniepp SJ. The Metrics of Quality Culture. 

https://www.pharmtech.com/view/metrics-quality-culture

Cole C. EMA and FDA collaborate on framework for AI use in drug development. PharmTech.com. January 14, 2026. 

https://www.pharmtech.com/view/ema-and-fda-collaborate-on-framework-for-ai-use-in-drug-development

Pandey G and Borshchenko S. What FDA’s AI warning letter tells us about GMP accountability. 

. 2026. https://www.pharmtech.com/view/what-fda-s-ai-warning-letter-tells-us-about-gmp-accountability

Internal audits were positioned as a patient-safety control, not a documentation exercise, linking shop-floor performance to the end user of medicines. Audit risk was framed across strategic, tactical, and operational dimensions, with program strength driven by auditor capability, agenda design, and how findings are communicated. Effective teams balance internal knowledge with external independence and targeted technical expertise. Risk-based scoping prioritizes time by trends and site context. Remote methods support analytics, but on-site observation remains essential to assess quality culture and execution. AI-enabled systems require GMP-grade controls.

At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.


Successful Internal Audit Planning and Execution

CPHI Milan 2026: AI and Bioavailability, Part 1

, Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, discusses how molecules move from discovery into clinical development. He explains that developing a molecule requires manufacturers to take into consideration chemical, physical, and biological properties, which allows teams to build a formulation strategy suited to both the molecule’s characteristics and the clinical dose needed for therapeutic effect.

Understanding where a compound sits on the solubility-permeability plot helps determine which enabling technology is likely to succeed, whether that's amorphous solid dispersions, lipid-based systems, or simple particle size reduction for dissolution-limited compounds, according to Parker.

Parker stresses that manufacturability and scale-up risks must be considered from the earliest stages, not addressed retroactively. He uses amorphous solid dispersions as an example: the same drug-polymer combination can behave differently depending on whether it’s produced by spray drying or hot melt extrusion, each yielding distinct solid-state stability pathways that affect long-term performance. For spray-dried products specifically, parameters such as spray rate, temperature, and residual solvent levels must be tightly controlled during tech transfer and scale-up to keep particle morphology and material properties consistent across equipment sizes and manufacturing sites. Failing to plan for this early can force costly re-engineering later, potentially undermining data already used to support clinical development.

Artificial intelligence (AI) is playing a greater role in drug development. AI has shortened formulation development timelines, particularly on the drug product side. AI has enhanced formulators ability to use Bayesian optimization, rather than relying on traditional design-of-experiments approaches, to more quickly converge on a target formulation profile, streamlining the path to optimized, finalized compositions for both drug substance and drug product development.

Quotient Sciences can be found at Booth 6K73 at CPHI Milan, which is occurring from October 6-8, 2026.

Click the video above to watch part 1 of this 2-part interview.

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a holistic view of its chemical, physical, and biological properties.