Christopher Cole

Sharp Invests in Injectables | Created with Canva

As the pharmaceutical landscape continues to shift toward biologic drug delivery, the technical requirements for secondary packaging and cold chain logistics have become increasingly complex. To address these demands, Sharp is expanding its infrastructure in Hamont-Achel, Belgium, and Heerenveen, The Netherlands, focusing on the assembly and 

 such as autoinjectors, pen devices, pre-filled syringes, and vials, according to a press release from the company (1). These expansions represent a significant shift in available regional capacity for the European market.

How is technical capacity evolving to meet injectable drug delivery requirements?

The modernization of these facilities reflects the growing need for specialized environments to handle sensitive injectable products (1). In the Netherlands, the expansion involves increasing 

 (GMP) production capacity, which includes the installation of two Grade D packaging suites scheduled to be operational in 2026. These suites are designed to accommodate new vial packaging and syringe assembly programs, providing the necessary controlled environments for high-value biologics.

Simultaneously, the Belgian facility is undergoing a major transformation to resolve potential bottlenecks in storage and assembly (1). The project will quadruple existing cold-chain warehouse capacity and double the available ambient storage space. To further streamline the transition from development to market-scale production, a new syringe assembly and blister packaging suite is being added, with plans for further device assembly and packaging lines. For manufacturing leads, the integration of collaborative robot technology onto pre-filled syringe and autoinjector packaging lines is a notable development aimed at enhancing production efficiency and consistency.

Why do these infrastructure updates matter for long-term supply chain resilience?

Beyond immediate throughput, the expansion aligns with the industry's focus on sustainable manufacturing and reliable market entry within the European Union (1). The Belgian site has been upgraded with a carport solar system designed to supply 50% of the facility's electricity once it is fully commissioned in mid-2026. This focus on renewable energy allows pharmaceutical partners to meet internal sustainability targets while maintaining a robust supply chain.

Robert O’Beirn, managing director, Sharp Clinical & Sharp Europe, commented in a Sharp press release: “Our European facilities have a long-established reputation for successfully delivering the complex packaging services required for injectable drug formats. This investment represents a significant increase in our capacity to support our pharma clients, as sustainably as possible, with their injectable drug launches in the EU market” (1).

By increasing the scale of available GMP space and incorporating advanced automation, these upgrades provide a pathway for pharmaceutical developers to navigate the regulatory and logistical hurdles of launching injectable therapies. The combination of expanded cold storage and specialized assembly capacity ensures that the infrastructure can support the full lifecycle of complex drug delivery devices.

How is the investment part of Sharp’s larger plans?

In October 2025, Sharp announced plans to invest $100 million across its United States and European facilities to expand capacity for injectable and oral solid dose medications (2). This initiative addresses rising market demand for autoinjectors and pre-filled syringes through modernized assembly lines and sterile filling.

Technical infrastructure upgrades announced by Sharp at the time (2):

• Injectable Assembly: New packaging suites and automated lines are being established in Pennsylvania, Belgium, and the Netherlands to support complex delivery formats.

• Cold Chain & Storage: The facility in Belgium is quadrupling its cold storage capacity and doubling ambient storage to support sensitive biologics.

• Sterile Manufacturing: A new isolator-based filling line with lyophilization is being added in Massachusetts to increase sterile manufacturing throughput.

This expansion provides pharmaceutical developers with increased regional manufacturing capacity and sustainable production options for global commercial launches.

Sharp Services Invests Over €20 Million to Expand Injectables Packaging Capacity at its European Facilities

Sharp Services Invests $100 Million in US and European Facilities to Increase Capacity and Service Offerings

Articles

Sharp is expanding its facilities in Belgium and the Netherlands to meet the growing demand for biologic drug delivery, focusing on injectable formats like autoinjectors and pre-filled syringes. These expansions include increased GMP production capacity, cold-chain logistics, and advanced automation to enhance production efficiency. The upgrades also emphasize sustainability, with renewable energy solutions integrated into the infrastructure. This investment aligns with Sharp's broader strategy to increase capacity for injectable and oral solid dose medications, addressing market demand and supporting pharmaceutical developers in navigating regulatory and logistical challenges.

Sharp increases European injectable assembly and secondary packaging capacity to support the rising demand for pre-filled syringes and autoinjectors.

Sharp Expands European Injectable Packaging Capacity With €20 million Investment

The week’s coverage discusses leveraging agentic AI, sustainability, and resilient supply chains to transform global drug development and safety.

PharmTech Weekly News Roundup – Week of January 12, 2026

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

Dycem Celebrates 60 Years of Contamination Control

Dycem celebrates sixty years of innovation in contamination control and high-friction polymers to ensure safety in global regulated industries.

EMA and FDA Collaborate on Framework for AI Use in Drug Development

FDA and EMA establish ten guiding principles for safe, ethical AI application across the entire biopharmaceutical product development lifecycle.

Industry Outlook 2026: Navigating AI, Sustainability, and Operational Resilience

Industry experts predict 2026 will be defined by agentic AI adoption, sustainable manufacturing practices, and resilient, geographically diversified supply chains.

Integrating AI and Machine Learning in Drug Discovery and Development

Pharmaceutical companies leverage AI and machine learning to accelerate early-stage drug discovery, utilize digital twins, and streamline regulatory workflows.

Jubilant Biosys Announces New Facility in India

Jubilant Biosys expands its Noida facility to double chemistry capacity, integrating discovery and early-phase scale-up for pharmaceutical research clients.

Pharma Manufacturing Professionals Are Staying Put Despite Growing Uncertainty

Industry surveys show pharmaceutical manufacturing professionals face rising job insecurity but remain committed to the sector for intellectual stimulation.

Pharmaceutical Supply Chain Resilience in a Shifting Market

Biotech companies mitigate geopolitical risks by auditing supply chains and implementing multi-sourcing strategies to ensure stable essential material access.

Single-Use Systems Enable Commercial-Scale CGT Manufacturing

Single-use systems and robotic automation industrialize cell and gene therapy 

manufacturing by reducing validation burdens and enhancing process scalability.

SÜDPACK Medica to Unveil Next-Generation Sustainable Packaging and Streamlined Services at Pharmapack Europe 2026

SÜDPACK Medica introduces recyclable mono-material blister packaging and streamlined procurement services to advance sustainability in pharmaceutical and medical sectors.

The Transformative Potential of AI to Enhance Patient Treatment

AI technology enhances patient care by prioritizing clinical trials for unmet medical needs and enabling precision prescribing through digital health.

Tjoapack Expands Bottle Packaging at Netherlands Facility

Tjoapack boosts global capacity by adding flexible, GMP-compliant bottle packaging lines in the Netherlands while expanding its United States footprint.

Videos

Guiding Principles for AI Use in Drug Development | Created with Canva

The European Medicines Agency (EMA) and FDA, in a significant step in the regulatory oversight of computational tools in the pharmaceutical industry, have established ten core principles intended to support the safe and ethical 

throughout the entire path of a medicine, from early laboratory research to the manufacturing floor and eventual post-market oversight (1,2). This alignment provides a necessary framework to manage the complexity and dynamic nature of these tools, ensuring that the evidence produced is both accurate and reliable.

What are the ten core principles established for pharmaceutical AI?

The joint initiative identifies specific areas where pharmaceutical developers and technical standards organizations can align their practices (2). These principles are as follows:

1. Human-centric by design: The development and use of AI technologies align with ethical and human-centric values (2,3).

2. Risk-based approach: The development and use of AI technologies follow a risk-based approach with proportionate validation, risk mitigation, and oversight based on the context of use and determined model risk (2,3).

3. Adherence to standards: AI technologies adhere to relevant legal, ethical, technical, scientific, cybersecurity, and regulatory standards, including Good Practices (GxP) (2,3).

4. Clear context of use: AI technologies have a well-defined context of use (role and scope for why it is being used) (2,3).

5. Multidisciplinary expertise: Multidisciplinary expertise covering both the AI technology and its context of use are integrated throughout the technology’s life cycle (2,3).

6. Data governance and documentation: Data source provenance, processing steps, and analytical decisions are documented in a detailed, traceable, and verifiable manner, in line with GxP requirements (2,3).

7. Model design and development practices: The development of AI technologies follows best practices in model and system design and software engineering and leverages data that is fit-for-use, considering interpretability, explainability, and predictive performance (2,3).

8. Risk-based performance assessment: Risk-based performance assessments evaluate the complete system including human-AI interactions, using fit-for-use data and metrics appropriate for the intended context of use, supported by validation of predictive performance through appropriately designed testing and evaluation methods (2,3).

9. Life cycle management: Risk-based quality management systems are implemented throughout the AI technologies’ life cycles, including to support capturing, assessing, and addressing issues (2,3).

10. Clear, essential information: Plain language is used to present clear, accessible, and contextually relevant information to the intended audience, including users and patients, regarding the AI technology’s context of use, performance, limitations, underlying data, updates, and interpretability or explainability (2,3).

How will these standards impact drug development and manufacturing?

The implementation of these principles is expected to facilitate more efficient pathways for both traditional medicines and biological products, as the term drug in this context encompasses both categories across various jurisdictions (1-3). In a message to American Association of Pharmaceutical Scientists members (4), Mark Arnold, PhD, owner and principal, Bioanalytical Solution Integration, wrote "Today, after several months of collaboration, the FDA and the European Medicines Agency… are releasing a common set of 10 guiding principles to inform, enhance, and promote the use of [AI] generating evidence across all phases of the drug product life cycle. The integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving health care. AI technologies are anticipated to help promote innovation, reduce time-to-market, strengthen regulatory excellence and pharmacovigilance, and decrease reliance on animal testing by improving the prediction of toxicity and efficacy in humans."

The joint principles mean that future regulatory submissions involving AI will likely require more rigorous multidisciplinary integration and documented data provenance to meet good manufacturing practices expectations. As noted by Arnold, "As an advisor to an AI company, and a user of AI software, these are 10 short and clear guides." By adhering to these standards, companies can better prepare for future jurisdictional guidelines while contributing to a global innovation environment that prioritizes patient safety. European Commissioner for Health and Animal Welfare Olivér Várhelyi stated in an EMA news release, "The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies. The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety" (1). This foundational work is expected to evolve alongside the technology, maintaining a focus on demonstrated quality, efficacy, and safety (2).

EMA and FDA Set Common Principles for AI in Medicine Development. Press Release

Guiding Principles of Good AI Practice in Drug Development

Artificial Intelligence for Drug Development. Guiding Principles of Good aI Practice in Drug Development

American Association of Pharmaceutical Scientists. AAPS Community Digest  for Wednesday January 14, 2026. Email Newsletter.

The European Medicines Agency and FDA have established ten core principles to guide the ethical and safe application of AI in the pharmaceutical industry. These principles cover the entire lifecycle of a medicine, from research to post-market oversight, ensuring AI tools produce accurate and reliable evidence. The initiative aims to align practices among pharmaceutical developers and technical standards organizations, promoting innovation, reducing time-to-market, and enhancing regulatory excellence. This collaboration is expected to transform drug development, improve healthcare, and maintain a focus on quality, efficacy, and safety.

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and innovation across the life cycle of a drug.

Dycem celebrates 60 years | Created with Canva.

This year, the contamination control company Dycem celebrates its 60th anniversary, marking six decades of performance, trust, and innovation (1). Since its official establishment in 1966, the company has dedicated itself to creating solutions that make environments safer, cleaner, and more controlled across more than 50 countries and 30,000 sites worldwide (2).

The Dycem story began in 1960 when David Cecil Mills discovered a polymer with an exceptionally high coefficient of friction (2). By 1966, this material was being used in specialized applications, such as holding photographic film and delicate components in precise alignment under microscopes. The polymer’s naturally tacky, non-slip properties allowed it to stabilize materials without the need for mechanical fasteners or adhesives.

In the early 1970s, the company expanded into the commercial sector, introducing retail products like non-slip trays and coat hangers (2). However, a pivotal shift occurred when a workplace use case demonstrated the material’s ability to remove and retain contaminants from footwear. This discovery led to the launch of Dycem’s first contamination control mats in 1974 to support the growing semiconductor, pharmaceutical, and aerospace industries.

By 1977, the company formalized its structure as Dycem Limited, establishing two core divisions: non-slip products and contamination control solutions (2). The following decades were defined by international growth and quality benchmarks:

• 1984: Dycem opened a dedicated office and warehouse in the United States to support local distributors.

• 1993: The company achieved ISO 9002 certification, reinforcing its commitment to global quality standards.

• 1998: Dycem revamped its non-slip consumer range, including bottle and jar openers designed to assist those with arthritis or reduced hand strength.

• 2002: A new corporate identity was unveiled to reflect the company’s specialized focus on contamination control systems.

Between 2010 and 2014, Dycem expanded beyond traditional cleanrooms into new verticals, including food manufacturing, cosmetics, and nuclear facilities (2). This era also saw the introduction of modular and scalable systems like Floating Mats and Flexi systems. In 2016, the company was acquired by the Longacre Group, a move that enabled further global investment and commercial expansion.

Most recently, data centers have emerged as a critical growth sector in the 2020s, validating Dycem’s efforts to provide contamination control for vital digital infrastructure.

Today, Dycem is recognized for its durable, reusable alternatives to disposable solutions, aligning high-performance floor-level risk reduction with corporate sustainability (1). As the company enters its next 60 years, it remains focused on supporting high-risk industries—from pharmaceutical manufacturing to laboratories—with solutions built on quality, reliability, and continuous improvement (1).

Dycem. Dycem Celebrates 60 Years of Innovation, Performance, and Trust. Press release received via email.

Dycem, a leader in contamination control, celebrates its 60th anniversary, marking a legacy of innovation and trust. Founded in 1966, the company has expanded globally, providing solutions across 50 countries and 30,000 sites. Initially focused on non-slip products, Dycem shifted to contamination control in the 1970s, supporting industries like semiconductors and pharmaceuticals. The company has achieved significant milestones, including ISO certification and strategic growth into new sectors. Today, Dycem emphasizes sustainability and continues to innovate for high-risk industries, ensuring quality and reliability.

Dycem marks 60 years of innovation, evolving from polymer science discovery to a global leader in contamination control across regulated industries.

Businessman using magnifying glass to recruit people 3D rendering | Image Credit: © sdecoret - stock.adobe.com

 annual survey of employment trends, conducted during the fourth quarter (Q4) of 2025, reveals a workforce navigating a complex period of high personal engagement and systemic instability. While professionals remain intellectually driven, a growing sense of job insecurity and a cautious outlook for the industry’s growth define the current sentiment. The 2025 survey results speak to accelerated AI adoption across R&D and manufacturing (1), regulatory innovation paired with heightened scrutiny (2–4), ongoing geopolitical and supply chain pressures (5,6), and workforce strain and skills realignment (7), among other trends the industry experienced in 2025 and expects to experience into 2026 and beyond.

How are satisfaction and salary balanced?

Overall job satisfaction has seen an interesting shift. In the latest survey, 30% of respondents reported being fully satisfied with their current job, a notable increase from the same survey conducted a year prior (Q4 2024), in which less than 15% expressed such satisfaction. However, this hasn't translated to financial contentment; only 16% are fully satisfied with their current salary, a figure that has remained virtually stagnant across the past 12 months.

The drivers behind this satisfaction remain consistent. Intellectual stimulation (50%) and a good work/life balance (43%) were the highest-rated contributors to satisfaction, with the value placed on work/life balance seeing a significant growth compared with being considered a top factor for only 31% of respondents in 2024 (

How has the threat of involuntary change and instability changed?

One of the most significant findings is the decline in perceived job security. Currently, 25% of professionals feel "much less secure" in their roles than they did a year prior, representing a sharp rise in anxiety, as only 11% felt this insecure in Q4 2024 (

). This fear is grounded in turnover trends: 27% of respondents experienced an involuntary job change in the past two years, nearly doubling the 14.5% reported in 2024. Conversely, voluntary changes remained low, around 16%, across both years, suggesting that while many may be unhappy, they are holding onto their roles in a volatile market.

Despite these pressures, loyalty to the field remains high. Indeed, more than 46% of respondents strongly disagree with leaving the bio/pharma industry entirely, a dip from the 59% who felt this strongly about staying a year prior but still an indication of a robust commitment to the sector.

What’s new in the area of professional development?

Perceptions of training have improved in the past 12 months. Approximately 57% of professionals agreed that sufficient role-specific training is provided by their employers, up from about 49% in 2024. Furthermore, 59% now believe new employees enter the workforce with an appropriate knowledge base, a significant improvement from the 46% who agreed with that statement in 2024.

However, companies are struggling with rapid digitalization. Only 7% view their company as an industry leader in bridging the digital skills gap. A concerning 30% believe their company is trailing behind others in the industry, and 27% feel their organization is trailing in attracting and retaining top talent as technology shifts.

The outlook for the future is one of cautious stabilization. For 2026, 52% of respondents expect the state of the industry to remain about the same, while only 23% expect it to be better. This contrasts with the 2024 results, when 44% held a more optimistic view that the industry would improve. Regarding quantitative outcomes for the coming year, the consensus is split; 39% expect a slight increase, while 36% believe outcomes will stay the same.




The Year of AI: 2025’s Bio/pharma Upskilling Revolution.

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CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

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Navigating Geopolitical Shifts, M&A, and Supply Chain Resilience

The Bio/pharma Industry Navigates AI’s Impact on Workforce and Hiring

The 2025 PharmTech employment trends survey highlights a workforce experiencing high engagement but facing systemic instability. Despite increased job satisfaction, financial contentment remains low, with only 16% satisfied with their salary. Job security concerns have risen, with 25% feeling less secure than a year ago. Training perceptions have improved, yet digitalization challenges persist. The industry outlook for 2026 is cautiously stable, with 52% expecting conditions to remain unchanged. AI adoption, regulatory changes, and geopolitical pressures are key factors influencing the bio/pharma sector's current and future landscape.

Survey results show a shift in pharma industry sentiment from optimism to caution as rising insecurity offsets high satisfaction and intellectual engagement.

Businessman overlooking cityscape with 2026 digital overlay, future vision | Image Credit: © Jayk - stock.adobe.com

To formulate a definitive roadmap for the pharmaceutical development and manufacturing landscape of 2026, the 

 content team connected with more than 30 industry experts, representing a comprehensive cross-section of the industry, including contract research organizations, contract development and manufacturing organizations (CDMOs), specialized manufacturers, genomic sequencing firms, consultants, and scientific AI innovators. These experts revealed that 2026 will be defined by a shift from incremental technological pilots to a profound system-level change.

Neil Smith, CPG President at Schneider Electric, captures the essence of this transition, noting that the coming year will “reward manufacturers who connect the dots” by modernizing data foundations and deploying agentic AI to “free trapped value from legacy manufacturing constraints.”

How is AI adoption changing in the industry?

The pharmaceutical industry has moved past the "inflated expectations" and "disillusionment" that characterized the previous two years. Beena Wood, chief product officer at Qinecsa Solutions, describes 2025 as a year during which the industry simultaneously balanced breakthrough technological announcements against the disillusionment of failed pilots and the rise of a "

." Regarding this state of uncertainty, Wood states, "Unless we open the box of specific AI implementation within an organization, it's in superposition of either transformative success or an epic failure." She notes that while many organizations faced "failed pilots" and a "trough of disillusionment," 2026 marks the "plateau of productivity" for those who have established the necessary prerequisites.

Mirit Eldor, managing director, Elsevier, declares 2026 as the true “year of the agent,’ explaining that while agentic AI was discussed heavily in 2025, it is only now making a measurable difference in R&D processes. This shift is supported by specific examples from leaders like Lilly (1) and the EPFL (2), which show that autonomous agents are finally “making the difference in life sciences.”

The impact of AI on drug discovery and development has become transformative. Dr. Eva-Maria Hempe, executive director, public sector EMEA, NVIDIA, explains that 

AI serves as a "flashlight" in the vast chemical space

, helping researchers orient themselves and identify drug compounds in months rather than years.

Veronica DeFelice, director of biologic products, Sapio Sciences, adds that in 2026, identifying disease targets relies on 

 exploration before any wet-lab validation begins, transforming target discovery from a manual search into a "continuous analytical workflow."

Manish Garg, principal engineer and associate director, Hikma Pharmaceuticals, emphasizes that 

AI "dramatically cuts costs and timelines"

 by efficiently analyzing vast data sets that would be impossible to process via traditional trial-and-error methods.

Furthermore, Neil Ward, vice-president and general manager of EMEA, Pacific Biosciences, notes that genomic data are set to grow immensely, making AI the only viable way to interpret the "tens of thousands of lines of code" involved in analyzing a single person’s genome.

In the manufacturing and operational sphere, AI has moved beyond discovery into the "

" of production, according to Megha Sinha, CEO, Kamet Consulting Group. “In discovery, AI will increasingly sit on top of curated scientific and clinical knowledge, prioritizing what to explore—targets, molecules, indications—rather than “replacing” the science,” she adds. “In manufacturing, the real step-change will come from agentic systems that combine digital twins, process data, and regulatory rules to recommend parameter changes, highlight risks, and propose implementation plans instead of just flagging anomalies.”

Smith highlights the emergence of "agentic systems" that proactively recommend actions, such as golden clean-in-place cycles to reduce waste, chemical, and water use. Laine Mello, director of marketing, Ecolab, notes that predictive maintenance tools are now "catching equipment issues before they cause batch failures."

However, Andrew Mitchell, senior director Business Development, BioVectra, points out a significant barrier: the high cost of licenses. "You clearly can't use a public, open data AI model," Mitchell argues, noting that companies must invest in proprietary AI agents that are specific to their organization. Wood echoes this caution, warning that "no amount of AI sophistication will help" if the underlying data foundations are fragmented, non-interoperable, or not validated for AI use cases. “The good organizations are the ones who are starting to do those boring foundations so they can scale very quickly afterwards,” she adds.

What are the impacts of geopolitical trends?

Geopolitical uncertainty, trade tensions, and rising tariffs have forced a radical reimagining of supply chain architecture. Matt Paterson, chief strategy officer, Quotient Sciences, observes that biotech and pharma clients are "optimizing and diversifying their geographic footprint" to mitigate the effects of political instability. Many organizations are adopting a multi-region strategy, qualifying facilities in both the United States and the United Kingdom to ensure continuity of supply for life-altering medicines.

Henrik Johanning, senior vice president, Epista Life Science, points out that "

" as manufacturers respond to single-source dependencies and "global regulatory convergence."

Raj Puri, chief commercial officer, Argonaut Manufacturing, describes

 the "chilling effect" of unpredictable tariffs

, sharing an account of being "hit with a seven-figure tariff on one of the key pieces of equipment" during a three-year investment plan for a new manufacturing site. Despite this "unwelcome surprise," Puri notes that tariffs have "created additional interest in US-based CDMOs" as a potential strategy to keep down cost of goods sold.

Campbell Bunce, PhD, chief scientific officer, Abzena, confirms this t

rend toward "on-shoring," noting a "genuine shift" and a "big focus in the US" for manufacturing drug substances

. “We’re seeing a lot of our customers make deliberate moves to ensure that security of supply is within the US.”

In India, the strategy is shifting toward 

local sourcing and significant inventory buildup to de-risk operations,

 according to Saharsh Davuluri, vice chairman and managing director, Neuland Laboratories. He reports an "increasing trend in which our customers...would like to see several months, sometimes six months, of API stock being held in their warehouses" to prevent disruptions from geopolitical issues.

Sinha predicts, that by 2026, leading organizations will t

reat supply chains as "living decision engines

: platforms that connect products, SKUs, licenses, sites, tariff exposure, and regulatory requirements in one knowledge layer and then let you simulate, ‘If this lane fails or this tariff goes live, which tech transfers, marketing authorization holder changes, label updates, and tenders are affected, and what’s the fastest viable plan B?’”

What advances are expected in next-gen modalities?

The therapeutic pipeline of 2026 is dominated by high-value, complex molecules. Mitchell identifies antibody-drug conjugates, radioligand therapies, and RNA therapies as the "boom" sectors of the moment.

" as a particularly exciting area, specifically for treating muscular dystrophies. He cites Novartis's acquisition of Avidity for $12 million as a clear indicator of the "exciting nature" of utilizing these approaches for difficult-to-treat indications (3).

The growth of high-potency APIs is also reshaping facility requirements, says Lidia Garcia Martin, MSAT & new productions head, Recipharm. She explains that these compounds offer notable clinical promise but demand "sophisticated handling, containment, and process control."

Ashu Tandon, chief commercial officer, Aragen, confirms that as FDA approvals for high-potent small molecules rise, customers are aggressively looking to "secure high potent containment capacities." This shift places a premium on robotics and closed-system technologies that "reduce manual handling and mitigate exposure risks."

Ward adds that breakthroughs in treating repeat expansion disorders, such as Huntington’s disease, will spark a surge of investment in 2026, requiring the broader adoption of long-read sequencing to analyze complex DNA repeats.

DeFelice notes that biologics discovery will focus on "multi-specific antibodies and engineered proteins that address complex biological targets through novel binding mechanisms. These formats are designed to interact with multiple targets or modulate disease pathways in ways that traditional monoclonal antibodies cannot.”

How are sustainability efforts moving beyond compliance?

Sustainability has transitioned from a simple reporting requirement to a foundational operating principle in 2026. Carolina Egea Millet, general manager, Agarose Bead Technologies, notes that manufacturers are redesigning production methods to "reduce solvent consumption and minimize waste," particularly in downstream purification, which accounts for a substantial proportion of total water and resource usage.

Mello adds that companies are discovering that "reducing water and energy consumption isn't just good for the planet; it's improving their bottom line and making operations more resilient."

Smith argues that it is time to retire the use overall equipment effectiveness (OEE)—which can be "misleading" as it only measures actual vs. planned utilization (eg, a “100% OEE for a production line that only runs once a week does not mean you are running a capital-efficient plant”)—in favor of a capital and carbon efficiency metric that bridges financial and sustainability goals.

Garcia Martin suggests that “high-potency manufacturers are prioritizing energy-efficient HVAC systems as well as facility layouts that minimize waste and unnecessary airflow demands. Process selection is also evolving, with solvent-free or solvent-reduced techniques gaining traction, supported by closed systems and isolators that limit emissions and improve material efficiency.”

What workforce and digital skills gap developments are occurring?

The rapid digitalization of the industry has created a "widening skills gap" between traditional good manufacturing practice (GMP) roles and newer, data-driven positions, according to Johanning. He observes that 

digitalization is separating "traditional GMP roles" from "automation- and data-driven roles

Remco Munnik, owner and founder, ARCANA Life Sciences Consulting, adds that in the past, a pharma professional was primarily a scientist who became an administrator, but now 

they must be a "data analyst or data scientist"

 capable of extracting insights from machine learning and statistics.

Sinha argues that the goal is not to turn every scientist into a software engineer but to 

create "T-shaped orchestrators" who understand the cross-functional nature of the business and can work with "AI-generated impact assessments

." She suggests training teams to "supervise agents, not configure tools," teaching experts how to interrogate system-generated plans.

To attract and retain this talent, Puri emphasizes that "

the only long-term, sustainable advantage we have as a CDMO is our staff,

" as facilities and equipment can be replicated, but human expertise cannot.

What does the regulatory frontier look like?

Smith, Johanning, and Egea agree that regulatory expectations are intensifying around data integrity and traceability. Johanning points to the 

maturity of European Union GMP Annex 1 implementation

 (5), noting that many sterile facilities are finding that "procedural compliance is insufficient" and requires tangible upgrades to utilities, particularly water and HVAC systems. He also highlights Annex 11 and Annex 22, which drive expectations for the lifecycle management of computerized systems and ensure digital tools are governed under the pharmaceutical quality system (6,7).

Frits Stulp, Partner Life Sciences, Implement Consulting Group, introduces the concept of "

," secure cloud environments where regulators and industry professionals can work in the same document to "accelerate the regulatory process." He calls this a "partnership for patients" and believes it will change the game by allowing faster discussions between applicants and regulators.

Munnik discusses the work of the Regulatory Optimisation Group (8), which has been working with European regulators and seeks to automate lifecycle management changes, such as name or address updates, by submitting them directly into a database so everyone is informed at the same time and to improve "speed to market, but also compliance."

How are digital twins and prevention impacting clinical trials?

Clinical trials are also undergoing a digital metamorphosis, according to Paterson, Dr. Gen Li, founder and president, Phesi, and Meri Beckwith, Co-CEO, Lindus Health. Li predicts that 2026 will be the year that digital twins "finally hit the mainstream" in clinical development, as regulators like FDA finalize risk-based guidance for digital trial arms. This would allow sponsors to optimize protocols, reduce costly amendments, and accelerate timelines. Li also predicts that "prevention" will emerge as the new blockbuster, as researchers investigate GLP-1 therapies for more than 100 diseases beyond diabetes and obesity, including cardiovascular disease and osteoarthritis.

pharma is finally treating "clinical operations as a strategic advantage

," using AI for precision patient matching and site selection. He emphasizes that there will be increasing pressure for real-world evidence (RWE) that reflects actual clinical use, driving innovation in continuous data collection via connected devices.

 drug design and the use of RWE in regulatory submissions

 will be primary drivers of innovation in 2026.

How should facilities and infrastructure be future-proofed?

Looking ahead, Smith and Garg agree that manufacturers are being urged to upgrade aging infrastructure to meet the demands of Industry 4.0. Smith points out that the average operational technology asset has been in service for 11 years, and many lack the "embedded security and AI integration" required for autonomous operations. Consequently, 2026 will see an accelerated hardware refresh cycle as companies move toward modular, interoperable industrial internet of things (IoT) systems.

manufacturers plan for significant investment in upgrading existing facilities

 into "smart factories" that incorporate IoT sensors, robotics, and cloud computing. Garcia Martin suggests that facilities must ensure adaptability, with flexible process suites that can transition "seamlessly from development to commercial production."

API sector has traditionally been "primitive" in its adoption of automation

 and must catch up by implementing distributed control systems, flow chemistry, and electronic batch records to stay on par with modern biologics manufacturing.

What’s occurring in pharmacovigilance and patient safety?

The future of pharmacovigilance is shifting from reactive reporting to "i

," notes Wood, who envisions a system that can detect unusual reactions across multiple languages in hours rather than months, cross-referencing global cases and identifying genetic marker correlations using real-world data. She notes that while this is "theoretically possible," the industry must first overcome the "uncomfortable truth" of fragmented data foundations. Wood advocates for "translational safety," which involves connecting the dots earlier in development rather than waiting for post-market surveillance. This proactive shift requires fundamentally rethinking how decisions are made under uncertainty, ensuring that scientists do not get "stuck because the decisions are unclear" due to disconnected data systems.

How does synthesis represent a turning point for industrial intelligence?

As the industry maneuvers through 2026, the convergence of AI automation, supply chain regionalization, and sustainable efficiency is creating a new operational reality, according to Garg, Smith, and Hempe. The golden clean-in-place cycles, T-shaped orchestrators, and trusted regulatory spaces are not merely concepts but the necessary components of a modern industrial strategy. Smith concludes that 2026 marks a "turning point for industrial players who move beyond incremental fixes and embrace system-level change."

The experts agree that the objective of 2026 is to compress time-to-market while protecting margins and patient safety. Whether it is through the deployment of digital twins to optimize clinical protocols, the use of biocatalytic manufacturing to scale siRNA production, or the strategic application of 505(b)(2) pathways to repurpose existing APIs, the focus remains on agility and evidence-based decision making. The insights from these industry leaders suggest that while the challenges of tariffs, skills gaps, and regulatory complexity are significant, the technological tools and collaborative frameworks available in 2026 offer an unprecedented opportunity to redefine how life-saving medicines are discovered, manufactured, and delivered to patients worldwide.

Lilly. Lilly Partners with NVIDIA to Build the Industry's Most Powerful AI Supercomputer, Supercharging Medicine Discovery and Delivery for Patients. Press release. Oct. 28, 2025. 

The pharmaceutical industry is poised for transformative changes by 2026, driven by AI advancements, geopolitical shifts, and sustainability efforts. AI is expected to revolutionize drug discovery, manufacturing, and clinical trials, with agentic systems and digital twins playing pivotal roles. Geopolitical uncertainties are prompting supply chain diversification and on-shoring strategies. Sustainability is becoming a core operational principle, with a focus on reducing waste and improving efficiency. The industry faces a skills gap due to rapid digitalization, necessitating new workforce strategies. Regulatory expectations are intensifying, emphasizing data integrity and collaboration in secure environments.

Pharma industry experts indicate that strategy in 2026 is shifting to agentic AI, sustainable efficiency, and resilient supply chains to manage tariffs, regulations, and digitalization. 