Richard Jaenisch surveys pharma's biggest recent AI deals

Manufacturing Intelligence: Sizing Up Pharma's Biggest AI Deals, Part One

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly

Regulatory Actions Impacting Biologics

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

Regulatory Actions for June 2026

The use of artificial intelligence is facing harder questions of governance and data quality

PharmTech Weekly Roundup—July 17, 2026

How evolving regulatory expectations are reshaping pharma development and manufacturing.

Drug Digest April 2026

Regulatory Roundup for July 2026

This month in pharmaceutical regulations, in the United States, the FDA proposed modernizing the regulatory infrastructure that governs how drugs are made, and expanded patient access to treatments across oncology, cardiometabolic disease, neurology, and rare genetic disorders.

 that would let distributed “hub-and-spoke” manufacturing networks register as a single establishment, while also closing a registration gap for foreign API makers to improve supply chain visibility.

According to Henrik Johanning, senior vice president, Quality & Strategy at Epista, “Registering a distributed network as a single establishment is the right move operationally, but it consolidates quality accountability rather than reducing it. 'One establishment' only holds up if the central quality hub genuinely controls every manufacturing unit,” Johanning told 

. “The same quality system, data integrity, and lifecycle discipline across equivalent sites. The administrative simplification is indeed welcome; what it concentrates in the hub is exactly what manufacturers should be planning for.”

Manish Garg, associate director, IT Applications, Serialization, Track & Trace, at Hikma, told 

that, “The proposed hub-and-spoke registration pathway is narrower than it may first appear. It applies to a specifically defined distributed-manufacturing model which is equivalent manufacturing units operating under a single quality unit and unified pharmaceutical quality system and not to conventional multi-site or CMO-based networks. That distinction matters because, if the rule is finalized, the practical challenge for qualifying manufacturers will not simply be administrative. It will be maintaining two levels of identity and visibility across the same operating network: a consolidated establishment identity and precise unit-level operational records.”

“FDA may allow a qualifying distributed manufacturing establishment to register as one establishment, but its individual units would not become operationally invisible. The proposal would still require an identifier and location information for each distributed manufacturing unit, including advance notification of relocation,” Garg continued. “Manufacturers would therefore need to preserve reliable relationships among FDA registration data, unit locations, quality systems, regulatory submissions, and manufacturing records and, where serialized finished products are involved, the location master data used in traceability systems. A single FDA establishment identity should not be interpreted as permission to collapse the physical-location detail upon which batch genealogy, investigations, inspections, and recalls depend.”

“The foreign-establishment provision may have the more immediate supply-chain impact. By aligning the regulations with the PREVENT Pandemics Act, FDA is clarifying that certain foreign establishments, which includes API manufacturers, would be expressly required to register and provide drug-listing information even when their products undergo further processing at another foreign establishment before reaching the United States,” Garg told 

. “Prior regulations did not directly address this fact pattern; the proposal would close that regulatory visibility gap.This is not ingredient-level serialization or DSCSA-style event-level traceability: it does not create serialized API identifiers or require electronic event exchange for upstream materials. It is, however, a meaningful step toward stronger upstream visibility. The broader signal is that regulatory identity, manufacturing-location data, quality records, and supply-chain data can no longer be governed in entirely separate organizational silos.”

And Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines, in 

FDA Updates Guidance and Approves Medicines

In other US regulation updates, the FDA revised draft product-specific guidance documents for 

—including semaglutide and tirzepatide—tightening expectations for immunogenicity testing, impurity thresholds, and structural characterization ahead of a September comment deadline.

The agency also published guidance regarding the development of psychedelic drugs.

See below for more guidance documents published in July.

The agency approved several medications in July for the treatment of lung and breast cancer, Alzheimer’s, and other conditions. FDA also approved Casgevy, the CRISPR-based gene therapy, for children as young as two with sickle cell disease or transfusion-dependent beta thalassemia, marking the youngest approved age group for gene-editing therapy.

Together, these actions show FDA balancing streamlined manufacturing oversight with an accelerating pace of therapeutic innovation.

What’s New in European Pharma Regulations?

In Europe, activity by the European Medicines Agency (EMA) centered on regulatory modernization paired with expanding access to innovative therapies, such as new phased-review pathways, first-in-class oral and implantable medicines, and continued vigilance on drug safety and health equity.

EMA and the European Union's Innovation Council agency, EISMEA, deepened their partnership

 to help SMEs and biopharma innovators engage with regulatory requirements earlier in development, reducing risk and speeding novel therapies toward patients.

In her final annual address to the European Parliament's health committee, EMA's Executive Director highlighted 104 positive medicine recommendations in 2025 and outlined how the EU's incoming pharmaceutical framework will shorten evaluation timelines and strengthen critical medicines supply chains.

EMA's human medicines committee recommended 12 new medicines in July, including 3 cholesterol therapies and a rare-disease treatment under exceptional circumstances, while rejecting 3 applications and updating COVID-19 vaccines for the new XFG variant.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) saw record regulatory performance and growing international standing, while reinforcing patient safety vigilance and transparency around UK medicines.

According to MHRA's 2025-26 Annual Report 921 medicines were approved in the past year, and the agency created new frameworks for AI and rare disease regulation—cementing the agency's growing global regulatory influence.

MHRA strengthened safety warnings across all botulinum toxin type A products following rare cases of iatrogenic botulism, urging patients and prescribers to recognize symptoms like difficulty swallowing, slurred speech, or breathing problems that can appear up to four weeks after treatment.

In compendia news, EDQM's classification committee published new evidence-based reviews assessing non-prescription status for paracetamol-ibuprofen combinations and naloxone, guiding how EU member states classify these products for supply.

 general chapter 5.1.6 that modernizes alternative microbiological methods, clarifying supplier and user responsibilities and introducing risk-based validation strategies ahead of an April 2027 implementation date.

 launched their first trilateral prospective harmonization project, co-developing unified quality standards for osimertinib mesilate and its tablets to reduce duplicate testing across regions.

The European Pharmacopoeia Commission adopted 93 new and revised texts at its 185th session, including new monographs for olaparib and adalimumab, an anti-adulteration test for sorbitol and maltitol, and plans for a working party on 3D-printed medicines.

EDQM opened public consultation on two new European Drug Shortages Formulary monographs, for quetiapine capsules and a sulfamethoxazole/trimethoprim suspension, giving manufacturers standardized formulas to help mitigate supply shortages.

EDQM released Pharmeuropa 38.3 with 40 draft monographs and general chapters open for public comment through September 30, covering products from ezetimibe to an RSV vaccine, urging manufacturers to weigh in before drafts become binding standards.

EDQM and USP's joint Stakeholder Forum reaffirmed their long-running prospective harmonization partnership, with forum insights now available in a free on-demand course to help industry track global pharmacopoeial alignment.

These updates underscore EDQM's focus on accelerating international standards harmonization while keeping the door open for industry input before new requirements take effect.

For more on these and other stories, visit PharmTech.com

FDA Proposes Rule to Modernize Drug Manufacturing Registration. Press release. FDA. July 10, 2026. Accessed July 31, 2026 

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration

FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products. FDA.gov. Accessed July 31, 2026.  

https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products

Psychedelic Drugs: Considerations for Clinical Investigations. Guidance for Industry

. FDA. July 2026. Accessed July 31, 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease. Press release. FDA. July 1, 2026. Accessed July 31, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-young-children-sickle-cell-disease

EMA and EISMEA boost cooperation to accelerate health innovations. Press release. EMA. July 15, 2026. Accessed July 31, 2026. 

https://www.ema.europa.eu/en/news/ema-eismea-boost-cooperation-accelerate-health-innovations

Executive Director Emer Cooke's speech at the European Parliament's Committee on Public Health. Press release. July 14, 2026. Accessed July 31, 2026. 

https://www.ema.europa.eu/en/news/executive-director-emer-cookes-speech-european-parliaments-committee-public-health

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026. Press release. EMA. July 24, 2026. Accessed July 31, 2026. 

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-july-2026

MHRA delivers record performance as 2025-26 Annual Report and Accounts confirms growing global influence

Press release. MHRA. July 16, 2026. Accessed July 31, 2026. 

https://www.gov.uk/government/news/mhra-delivers-record-performance-as-2025-26-annual-report-and-accounts-confirms-growing-global-influence

Updated warnings for botulinum toxin products following rare cases of botulism. Press release. MHRA. July 15, 2026. Accessed July 31, 2026. 

https://www.gov.uk/government/news/updated-warnings-for-botulinum-toxin-products-following-rare-cases-of-botulism

CD-P-PH/PHO publishes two new evidence-based classification reviews. Press release. EDQM. July 20, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/cd-p-ph/pho-publishes-two-new-evidence-based-classification-reviews

Publication of revised Ph. Eur. general chapter 5.1.6 on alternative microbiological methods. Press release. EDQM. July 15, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/publication-of-revised-ph.-eur.-general-chapter-5.1.6-on-alternative-microbiological-methods

Ph. Eur., JP and USP announce the launch of a trilateral prospective harmonisation project on pharmacopoeial standards for osimertinib mesilate and osimertinib tablets. Press release. EDQM. July 13, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/ph.-eur.-jp-and-usp-announce-the-launch-of-a-trilateral-prospective-harmonisation-project-on-pharmacopoeial-standards-for-osimertinib-mesilate-and-osimertinib-tablets

Outcome of the 185th session of the European Pharmacopoeia Commission. Press release. EDQM. July 9, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/outcome-of-the-185th-session-of-the-european-pharmacopoeia-commission

Second issue of Pharmeuropa EDSForm published: two new draft European Drug Shortages Formulary monographs are now available for public consultation. Press release. EDQM. July 6, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/second-issue-of-pharmeuropa-edsform-published-two-new-draft-european-drug-shortages-formulary-monographs-are-now-available-for-public-consultation

Pharmeuropa 38.3 just released. Press release. July 1, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/pharmeuropa-38.3-just-released

USP-EDQM Stakeholder Forum reinforces commitment to pharmacopoeial collaboration and global alignment. Press release. EDQM. July 27, 2026. Accessed July 31, 2026. 

https://www.edqm.eu/en/-/usp-edqm-stakeholder-forum-reinforces-commitment-to-pharmacopoeial-collaboration-and-global-alignment

FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy

FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol


https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower

FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive

FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-home-starting-dose-alzheimers-disease-treatment

FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications

FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer

FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-nonprescription-fixed-dose-combination-acetaminophen-and-naproxen-sodium-12-hour

FDA Guidance Documents Issued in July 2026

Psychedelic Drugs: Considerations for Clinical Investigations

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-food-and-drug-administration-and-sponsors-or-requestors-over-counter

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/topical-dermatologic-corticosteroids-in-vivo-bioequivalence-0

Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-next-generation-sequencing-data-division-antiviral-products

FDA, Warning Letter to International Medication Systems Limited, July 2, 2026. Accessed July 31, 2026


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-medication-systems-limited-727560-07022026

FDA 
Drug Repurposing: Considerations for Selection Criteria and Prioritization

https://www.fda.gov/drugs/news-events-human-drugs/drug-repurposing-considerations-selection-criteria-and-prioritization-08052026

FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds

https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds

Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials

https://www.fda.gov/drugs/news-events-human-drugs/fda-virtual-workshop-digital-health-technologies-and-statistical-considerations-digitally-derived

Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs


https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-leveraging-model-integrated-evidence-mie-development-approval

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party

https://www.ema.europa.eu/en/events/meeting-medicine-shortages-single-point-contact-spoc-working-party-44

Videos

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026.

Regulatory Roundup—July 2026

ROSS 250-Gallon Retention Mixers Designed for High-Pressure Processing
Image Courtesy of ROSS

A new line of 250-gallon retention mixers from Ross has entered the market with design specifications aimed at applications requiring both product uniformity and pressure tolerance, addressing a persistent challenge for manufacturers handling reactive or settling-prone formulations during storage and transfer.

The mixers, fabricated from Type 304L stainless steel, are built and stamped to ASME Section VIII, Division 1 standards for pressure service and are rated for operation up to 200 psi at 300 degrees Fahrenheit. Each unit undergoes hydrotesting before shipment.

 Fifteen agitator blades, driven by a 15 horsepower motor at speeds up to 350 rpm, work alongside fourteen internal baffles to keep product moving throughout the vessel. A steady bearing stabilizes the shaft, which is sealed using a dry-running mechanical seal. The equipment can be configured with additional nozzles for material addition, ventilation, drainage, and instrumentation, and the mdesign scales up to 5,000-gallon capacities.

Why Does Retention Mixing Matter for Pressure-Sensitive Processes?

Retention mixing serves a specific function: maintaining a formulation's consistency after the primary mixing step is complete, through storage and eventual unloading.

 For manufacturers working with suspensions, emulsions, or reactive intermediates, settling or phase separation during a hold period can compromise batch quality even when the initial mix was sound. That risk grows when the process also involves elevated pressure and temperature, conditions common in reaction chemistry, sterilization-adjacent steps, and certain active pharmaceutical ingredient synthesis pathways.

Equipment rated for both continuous agitation and pressure containment allows a single vessel to serve as both a reaction or holding tank and a mixing system, rather than requiring product to move between separate units.

 That consolidation can reduce transfer steps, each of which introduces potential for contamination, degradation, or yield loss. It also matters for manufacturers pursuing tighter control over reaction yield, since incomplete or uneven mixing during a hold period can leave reactants unevenly distributed and reduce the efficiency of a chemical transformation.

What Should Manufacturing and Engineering Teams Consider?

For engineering and operations teams evaluating retention mixing equipment, the materials and certifications matter as much as the mechanical specifications.

 Stainless steel construction and ASME pressure-vessel certification are baseline requirements for many regulated manufacturing environments, particularly where equipment will contact active ingredients or intermediates subject to good manufacturing practice oversight. Hydrotesting before shipment provides documented verification that a vessel can withstand its rated pressure, which supports the qualification and validation work manufacturers must complete before putting new equipment into production use.

Configurability is another consideration.

 The ability to add nozzles for material addition, drainage, and instrumentation after the base design allows a single equipment platform to be adapted across multiple process lines rather than requiring custom engineering for each application. As pharmaceutical manufacturers face pressure to increase flexibility across smaller batch sizes and more diverse product portfolios, equipment that scales from smaller pilot volumes up toward much larger production capacities, without redesign, offers a practical path for facilities planning for growth or process changes.

What Does Powder Segregation Research Reveal About Downstream Risk?

The uniformity concerns that make retention mixing valuable for liquids and suspensions have a well-documented parallel in solid dosage manufacturing.

 A recent review of tablet production found that even well-mixed powder blends can separate again during subsequent handling, including transfer between containers, discharge from hoppers, and filling into dies. The review identified particle size difference as the primary driver of this separation, occurring through three main mechanisms: smaller particles filtering downward through gaps between larger ones, fine particles becoming suspended in air currents and settling unevenly, and particles of different sizes rolling at different rates across a surface.

The parallel to retention mixing is instructive.

 Just as a tablet blend can lose its homogeneity between the mixing step and the compression step, a liquid or semisolid formulation can settle or separate between agitation and unloading if it lacks continuous movement during that interval. The tablet manufacturing research also found that equipment geometry, fill method, and processing speed all influence whether separation occurs, reinforcing that uniformity is not just a formulation property but an equipment and process design outcome, whether the product in question is a powder blend or a liquid suspension held under pressure.

ROSS 250-Gallon Retention Mixers Designed for High-Pressure Processing

Blend Segregation in Tablets Manufacturing and its Effect on Drug Content Uniformity—A Review

Articles

High-pressure retention mixing addresses a common failure point in manufacturing: loss of homogeneity during hold and transfer for suspensions, emulsions, and reactive intermediates. A new 250-gallon ASME Section VIII, Div 1–stamped, 304L stainless vessel targets simultaneous agitation and pressure containment (200 psi at 300°F), using multi-blade agitation, baffles, steady bearing support, and a dry-running mechanical seal, with hydrotest verification. Emphasis is placed on GMP-aligned materials/certifications, configurable nozzle/instrumentation options, and scalable design up to 5,000 gallons, supporting flexible facility needs.

New 250-gallon retention mixers rated to 200 psi help pharma manufacturers maintain product uniformity and cut transfer risk.

Can One Vessel Handle Both Reaction and Retention Mixing?

PharmTech Weekly Roundup—July 31, 2026

, the theme of promise to practice was obvious. AI is being utilized in drug discovery, but plant-floor execution still lags behind. Regulators are modernizing rules for advanced therapies and peptides. And manufacturers are rethinking where and how they build capacity, transfer technology, and monitor quality in real time.

 to consolidate R&D at Cambridge Biomedical Campus while closing Stevenage and expanding scale-up manufacturing at Ware, reflecting a trend of placing research near academic and clinical hubs.

FDA revised draft guidance documents for 17 generic peptide products

 tightening expectations for impurity testing, immunogenicity, and structural analysis ahead of a September comment deadline.

 industry update continues. Halfway through the year, 

experts agree that next-generation modalities like ADCs and GLP-1s are advancing quickly

, but regulatory compliance and organizational readiness remain the industry's toughest execution hurdles.

Cheryl Barton, a contributing writer for PharmTech Europe, highlights how 

European biotechs are using AI-driven target discovery

 to push respiratory treatment beyond broad immunosuppression toward precision therapies for asthma, COPD, and pulmonary fibrosis.

 with his take on the FDA's proposed single-registration rule for distributed “hub-and-spoke” networks

. He says the rule could give personalized cell and gene therapy makers the regulatory clarity to build patient-proximate supply chains. 

Bock adds that earning FDA's trust under this streamlined model

 will require manufacturers to adopt fully digital, harmonized quality systems so deviations and corrective actions can be shared instantly across every site.

Industry experts from Kindeva, QbDVision, Mabion, and Symbiosis participated in a 

panel discussion on best practices for tech transfer

. The panelists say successful technology transfer depends less on paperwork and more on capturing the process understanding and hands-on operational knowledge that standard batch records typically leave out. 

They also described how tiered governance,

 clear escalation paths, and regulatory planning run in parallel with execution let sponsors maintain oversight of contract manufacturers without slipping into micromanagement.

 explains how fusing Raman, NIR, and other spectroscopic data with chemometric models enables real-time, automated control of nutrient feeds and quality attributes, supporting right-first-time manufacturing at scale.

, Robert Dream, managing director of HDR Company and a 

 Editorial Advisory Board member, explains how validated hold times protect biopharmaceutical quality between processing steps, and why cumulative hold time across an entire process matters as much as any single pause.

From AI's execution gap to regulatory modernization and real-time process control, it’s clear that manufacturing execution must catch up with innovation. For the full stories, visit PharmTech.com. 

Content on PharmTech.com this week showed that while AI is being utilized in drug discovery, manufacturing execution still lags behind. However, manufacturers are rethinking where and how they build capacity, transfer technology, and monitor quality in real time.

Mike Hennessy Jr. is the Chairman and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

Pharmaceutical manufacturing is entering a phase defined less by singular breakthroughs and more by systems-level maturity. Across development, manufacturing, quality, and outsourcing, the industry is being asked to scale complexity without sacrificing control, whether that means adapting to new modalities, tightening regulatory timelines, or managing an increasingly outsourced supply chain. The July/August 2026 issue’s contributors offer a snapshot of what that maturity looks like in practice.

Our cover story examines downstream purification in biologics, where resilience and adaptability are becoming as important as throughput itself; operations must be built to evolve alongside the industry, not just keep pace with it. That same tension between complexity and consistency runs through our development feature on personalized therapies, where raw-material variability remains one of the toughest obstacles to reliable CAR-T and cell therapy manufacturing. Strategies like batch qualification, robust data systems, and automation are moving beyond efficiency plays and becoming prerequisites for reproducibility at the patient level.

On the automation side, contract research organizations are confronting the limits of spreadsheet-driven operations. As experimentation scales, so does the cost of manual processes, not just in time, but in compliance risk, traceability, and auditability. It’s a reminder that digitization in contract research is becoming table stakes.

This issue’s regulatory feature turns to the shifting biosimilar landscape, where faster approval pathways are reshaping market access, but, as the author notes, faster doesn’t necessarily mean easier for development teams navigating the new requirements.

Finally, our outsourcing piece makes a case that documentation reliability across contract organizations can’t be an afterthought bolted on before an audit. It must be engineered into quality systems from the start.

Taken together, these articles reflect an industry maturing under pressure to be more personalized, more outsourced, more automated, and more scrutinized than ever. Building the technical, regulatory, and organizational systems that can hold up under that pressure is the throughline.

Pharmaceutical manufacturing is shifting from isolated innovations to systems-level maturity across development, manufacturing, quality, and outsourcing. Biologics downstream purification is prioritizing resilience and adaptability alongside throughput to support evolving modality demands. Personalized therapies, particularly CAR-T and cell therapies, remain constrained by raw-material variability, driving adoption of batch qualification, robust data architectures, and automation to enable patient-level reproducibility. CROs are moving beyond spreadsheets as scale amplifies compliance, traceability, and audit risk. Meanwhile, accelerated biosimilar pathways alter access dynamics without simplifying development, and documentation reliability must be designed into partner quality systems from inception.

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. 

Scaling Complexity Without Losing Control

 is vice president of R&D for Lonza Integrated Biologics where he brings more than 20 years of experience in cell biology, bioprocessing, media development, and process scale up experience to translate scientific innovation into scalable manufacturing processes.

In this role, he leads a team focused on developing and implementing innovative bioprocessing and analytical solutions across the product lifecycle. One current focus for our team is integrating technologies such as advanced process analytical technologies, automation, and digital tools to improve process understanding, accelerate development timelines, and enable more robust and predictable biologics manufacturing.

Close up of science experiment Vials filled inside an autosampler of an HPLC machine in a Science experiment laboratory for research analysis and clinical trial study | Image Credit: ©Paul Reverve -stock.adobe.com

Lonza's Atul Mohindra, head of R&D at Lonza Integrated Biologics, discusses how process analytical technology (PAT) is reshaping biopharmaceutical manufacturing. According to Mohindra, modern control strategies integrate spectroscopic tools like Raman and near-infrared spectroscopy (NIR) with chemometric models to enable real-time monitoring of critical process parameters (CPPs).

Mohindra addresses key technical challenges: bioreactor environments create high signal-to-noise ratios due to cell density and bubbles, requiring multivariate analysis and partial least squares modeling to extract reliable signals. Beyond single-parameter control, Lonza combines PAT data with traditional measurements (pH, DO, temperature) to build soft sensors offering a full-process view and early detection of out-of-trend events.

On scale-up, he explains that multi-scale training datasets help models remain robust across clones and operating conditions, with reference-measurement verification during site transfers or reactor geometry changes. Lonza's digital twin approach pairs mechanistic models with machine learning for complex, nonlinear dynamics to continuously recalibrate as PAT-generated data accumulates.

PharmTech: How does a PAT control strategy integrate multiple sensor modalities (e.g. NIR, Raman probes, and soft sensors), and how are data streams from these fused in real time to generate actionable process insights?

 A modern PAT control strategy is built on the integration of multiple novel sensor modalities, including spectroscopic tools such as Raman spectroscopy or NIR to improve process monitoring and control. For instance, Raman spectroscopy can be translated into metabolite concentration measurements using chemometric models that enable continuous monitoring. These continuous measurements of CPPs, provide the means to improve control of select critical quality attributes (CQAs) more consistently. As an example, Lonza’s newly developed intensified fed-batch platform leverages Raman models developed for glucose, phenylalanine, and methionine to control 3 nutrient feed rates during high-inoculum-density cultures without the need for manual interventions.

Beyond upstream process monitoring, chemometric models can also be used to measure CQAs in downstream applications. In addition to Raman spectroscopy, other PAT tools, including NIR and Fourier transform infrared spectroscopy (FTIR), can be applied to measure product concentration, aggregates, and excipients in the purified process streams during the appropriate downstream unit operations. Maintaining sufficient control of these process parameters supports right-first-time manufacturing by enabling target endpoints more consistently.

The ultimate goal is not just to measure and control single CPPs but integrate the breadth of data generated by novel PAT solutions with more traditional data streams (i.e., pH, DO, temperature) in order to develop soft sensors that can map out the whole process from start to finish. These soft sensors add another layer of process control, enabling real-time monitoring, capable of monitoring a process, real-time identification of out-of-trend (OOT) events, and timely process adjustment to bring these OOT events back within control. By aligning and processing these novel PAT and traditional data streams in real time within Lonza’s data platform, a unified view of the process is created. The output is a set of actionable variables, such as nutrient concentrations, metabolic indicators, and cell culture health, that can be used to inform operators or directly drive automated control strategies.

What are the biggest data quality and signal-to-noise challenges you face when deploying in-line spectroscopic sensors in a bioreactor environment, and how do chemometric models or multivariate analysis help overcome them?

Using in-line spectroscopic measurements in bioreactors can be inherently challenging. The process environment is complex due to high cell densities, bubbles, and other physiochemical effects making for high signal to noise ratios and therefore difficult to interpret data. This makes it difficult to directly interpret raw spectra, particularly for low-concentration analytes embedded in a dynamic process environment.

Chemometric approaches, such as multivariate analysis and partial least squares modeling, are essential to extract relevant information from this noise by identifying patterns that correlate with concentration changes of key analytes. For example, this strong performance model (R

>0.90) has been successfully applied to monitoring glucose, phenylalanine, and methionine, in order to deliver accurate and reliable measurements that would be difficult to achieve with other methods.

Robust model performance is also achieved through careful preprocessing and training on diverse datasets that capture expected variability across clones, scales, and conditions. Ongoing monitoring of model output and periodic updates help ensure these models continue to remain stable over time.

How do PAT-enabled glucose, lactate, and dissolved oxygen measurements translate into automated control decisions, and what measurable impact have you seen on titer and yield at commercial scale?

PAT-enabled measurements are first translated into actionable process variables using chemometric model-based approaches, allowing real-time estimation of nutrient levels (e.g., glucose and lactate) and metabolic states. These values are then compared to predefined process set points, with any deviation triggering automated real-time adjustments, such as changes in feed rates or aeration strategies.

This enables a more dynamic control approach that responds to actual cellular demand, rather than relying on fixed feeding strategies used in traditional and intensified fed-batch processes operated by Lonza. The result is tighter control of the culture environment, reduced variability, and improved process efficiency. In practice, this has led to a significant reduction in potential process deviations, while maintaining consistent product titer, yield and product quality at scale. In addition, spectroscopic measurements used for trending monitoring can alert operators to early signs of process drift, allowing for intervention.

Lonza is advancing PAT-driven biomanufacturing by integrating in-line spectroscopy (Raman, NIR, FTIR) with chemometric modeling to generate real-time estimates of nutrients, metabolites, and select CQAs across upstream and downstream operations. Multivariate methods, including partial least squares, mitigate bioreactor signal noise from high cell densities and bubbles and enable robust soft sensors when fused with conventional telemetry (pH, DO, temperature). Multi-scale model training and reference-method verification support scale-up and site transfers. Digital twins combine mechanistic models with machine learning and continuously recalibrate using high-frequency PAT data.

Atul Mohindra, head of R&D at Lonza Integrated Biologics, spoke with PharmTech about some of the recent advancements in analytical techniques for biopharmaceutical development and manufacturing. 

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