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Biotech Facilities: This New Tech Is Accelerating Drug Development & Reducing Time-to-Market 

Biotech Facilities: This New Tech Is Accelerating Drug Development & Reducing Time-to-Market

Drug development is expensive and often slow. The oft-cited Tufts estimates that the average cost of developing and winning marketing approval for a new drug is approximately $2.6 billion, with timelines running a decade or more. As with most things in drug development, those figures include both the cost of failed programs and the capitalised value of time. 

What goes by the name of a “drug” is also changing. Small molecules will always be important, but biologics, gene therapies, and cell therapies are moving to centre stage. These modalities hold scientific promise but also introduce new technical, manufacturing, and regulatory complexities. It is also why biotech facilities  EPC partners like Pharma Access  provide industrial scale facilities that can materially shorten timelines, reduce surprises, and help sponsors move from concept to clinic with fewer missteps. 

Biotech Facilities: What EPC and Consulting Involve

Good biotech EPC and facility and consulting is the highly practical intersection of scientific judgment, regulatory know-how, and project management  where consultants and teams make the right decisions at the right time. Below are the main value propositions consultants bring to each stage of the drug lifecycle: 

  • Biomarkers, Diagnostics, And Study Design 

Modern precision medicine programs depend on biomarkers and companion diagnostics. Consultants can advise on biomarker validation, companion diagnostic strategy, and how to design studies that produce regulatory-grade evidence for both drug and diagnostic. 

Manufacturing and CQV (Commissioning, Qualification & Validation): 

Biologics, cell and gene therapies, modular construction, and complex combination products need expertise, experience, and scale in manufacturing that often far exceed the capacity of early-stage teams which is where biotech can step in. Consultants provide CQV planning, process scale-up advice, and hands-on protocols that are easy to follow and reduce change orders during validation. Pharma Access, especially, helps with biotech success by delivering regulatory-ready cleanroom facilities that support complex biologics and advanced therapies.. 

How Pharma Access Drives Industry Excellence? 

Pharma Access’s approach matches engineering, regulatory, and program execution so that clients convert winning strategies into validated, runnable operations and upskill their teams.

  • End-to-end project delivery: From feasibility and process definition through to commissioning, qualification and validation (CQV), Pharma Access has regulatory rigour for managing capital projects. 
  • Modular facility solutions: Modular Mobile Facility (MMF) and other concepts that shorten construction timelines support phased scale-up. This is useful for programs that need early clinical supply before full-scale commissioning.
  • CQV and QbD know-how: With over 24 years of experience and successful completion of 100+ projects across 18+ countries, Pharma Access brings proven methodologies to every engagement. The company’s approach centres on Quality by Design (QbD) principles and simulation-based engineering that reduces risks and accelerates project timelines. 
  • Data-ready infrastructure: Our facilities are instrumented for analytics, digital twins, and future AI deployment, so your plant is a platform, not a project that supports biotech production.
  • Regulatory engagement & submission support: Pharma Access helps coordinate regulatory interactions from IND/CTA planning through dossier readiness.
  • Training and handover: Technology only succeeds when people are ready for it. Pharma Access supports training and competency programs to ease the transition to new processes and tools.

In short, Pharma Access combines engineering, regulatory and digital capabilities to let clients rapidly deploy modern development practices without sacrificing compliance or auditable traceability.

Reducing Time-to-Market Through Expert Guidance

Time is revenue and often patient impact, so shaving months or even weeks off development is meaningful. Consultants most frequently accelerate programs through three high-impact pathways: 

  • Smarter Facility Timelines: 

Modular, prefabricated, and simulation-based design accelerate readiness, which is where Pharma Access shines. BIM, CQV & Quality by Design (QbD) by Pharma Access help make more efficient products that get quicker ISO certifications and are fully safety compliant.

  • Early Risk Mitigation

Insights and experience from development teams mean they can often spot regulatory, CMC, or supply-chain risks early on and build those mitigations into the initial design. Pharma Access supplements these by noticing regulatory gaps in GMP design, utilities failures, and HVAC non-compliance. 

The value of this work is obvious: preventing advanced manufacturing failures or regulatory deficiencies results in avoiding long-term delays that can last months or years while saving millions of dollars and potentially lives.

  • Manufacturing Scale-Up Guidance: 

Manufacturing is where many late-stage programs stumble, and scale-up is where companies with limited manufacturing knowledge fall flat on their face. This is also one of the places where Pharma Access has built their capabilities. Our EMP consultants guide process transfer, equipment selection, and qualifications so you don’t end up doing the rework that kills your launch dates. Companies that engage our manufacturing process equipment and machinery experts early in development avoid many common scale-up challenges that can delay product launches by months or years, especially by noticing early defects and ensuring regulatory compliance alongside high standard products. 

Navigating Global Regulatory Complexities with Pharma Access: 

Regulatory pathways have gotten more flexible, but remain exacting for safety reasons. The average USFDA review time decreased from 26.6 months before the Prescription Drug User Fee Act (1992) to 9.9 months after implementation, demonstrating how regulatory processes have become more efficient. As an example, the U.S. FDA’s Centre for Drug Evaluation and Research approved 55 novel drugs in 2023, an example of both robust innovation and active regulatory throughput, but each approval reflects a differentiated submission strategy and a lot of planning. 

Regulatory agencies are also defining new frameworks for advanced modalities. The USFDA, for example, has its own lists of approved cellular and gene therapy products, and the agency’s guidance and review programs (including expedited pathways) are central to winning a regulatory plan. Biotech consulting services, such as those offered by Pharma Access, keep teams current on these programs and help design dossiers that anticipate regulator questions and challenges. We also ensure that our facilities meet USFDA, EMA, WHO, and GMP guidelines. Why is this valuable? It reduces inspection risks and cuts time that would have been wasted redoing compliance and safety. 

Global launches are complex. EMA, FDA, PMDA, and other regulators have overlapping but distinct expectations. Biotech consulting, especially with Pharma Access, can coordinate parallel filings and regional strategies so you do not finish first in the U.S. only to lose months in translation elsewhere. 

Helping Advanced Therapies and Biologics

The rise of advanced therapies has been striking. Regulatory approvals for cell and gene therapies, and the growing set of complex biologics, require manufacturing setups, clinical paradigms, and regulatory approaches that differ significantly from small molecules. 

  • Gene and Cell Therapy Development

These products require specialised manufacturing facilities, cryopreservation logistics and areas, and patient-specific workflows alongside controlled environments and modular units. EPA experts such as Pharma Access help design manufacturing networks and clinical supply chains that are practical, auditable, and acceptable to regulators such as the USFDA.

  • Biologics Manufacturing and Development

From cell line selection, through comparability studies and immunogenicity assessment, biologic programs rely heavily on process knowledge. Consultants, such as the experts at Pharma Access, also support modular and clean rooms, CQV practices to make scale-up more likely to succeed and HVAC, Mechanical, Electrical & Piping setups to ensure compliance and operational efficiency, with Pharma Access having expertise in noting HVAC non-compliance, CQW, and Mechanical and Electric Pipping System setups.

Success Stories and Impact

Here are verified, public examples showing how combining modern manufacturing, digital tools, and strong program plans produces outcomes that regulators accept and supply chains can deliver. 

  • Continuous Manufacturing & Time/Cost Gains:

Work on continuous manufacturing has been a bellwether for industry change, and reports say that continuous approaches can significantly reduce manufacturing time and cut waste/costs in specific contexts. The USFDA and ICH have issued guidance supporting the adoption of continuous processes where the control strategy and validation are robust. Pharma Access has the digital and AI-ready facilities that enable such continuous operations.

  • Digital Twins and Plant Digitisation:

Major companies have adopted digital twins and robust digital operations to improve decision speed and reduce downtime, and Pharma Access specialises in building such digital-ready infrastructure. Many partners have published projects on digital twin deployments for vaccine and biologics production, showing examples of how simulation and real-time data feed faster operational decisions. 

  • AI in Pharma R&D and Market Growth: 

The AI in pharma market is rapidly expanding: multiple forecasts place the 2024–2034 market CAGR in the high-20s to low-30% range, with market sizes moving from under $2B in 2024 toward double-digit billions by 2032–2034. This is evidence of broad adoption across discovery, development and manufacturing analytics, making Pharma Access’ AI-ready facilities a way to future proof your biotech endeavors. 

  • Predictive Maintenance & Uptime: 

Predictive maintenance is a repeatable value source in manufacturing operations. McKinsey and other industry analyses put predictive maintenance programs at roughly 30-50% reductions in equipment downtime when fully implemented. That’s direct, front-line impact on steadier production and fewer disrupted batches and this is where Pharma Access excels with our EPC programs and cutting-edge automation integration. 

Our cases show that the combination of technical know-how, digital tools, and regulatory planning is not theoretical: it is how leading products moved through development and into supply efficiently. 

Conclusion: 

Drug development will always be resource-heavy, but the right expertise shortens missteps and turns complexity into manageable workflows, especially saving times and thus lives. Verified trends show regulators are approving novel therapies steadily, and that digital and continuous manufacturing approaches deliver measurable operational benefits. Alongside this, results show that AI/digital tools improve both discovery and plant performance when paired with good data and governance.

Biotech consulting is no longer optional and Pharma Access provides the EPC expertise needed to design trials that regulators accept, to build manufacturing that scales and to launch products that payers will reimburse. Aka Pharma Access translates scientific expertise into GMP-compliant audit-ready facilities that shorten manufacturing time and accelerate time-to-market and cost effectiveness.

 If you want to accelerate biotech development while staying audit-clean and inspection-ready, alongside saving cost and lives,  expert consulting paired with a delivery partner like PharmaAccess is a practical, proven route.  

Frequently Asked Questions

Q: When is the best time for a biotech to get EPC partners?

Early is often the best. Engaging EPA partners before IND/CTA submissions and especially before critical scale-up milestones gives them the leverage to influence design, reduce risk, and prevent late rework. 

Q: How does Pharma Access connect with client teams and consultants? 

Good consulting augments, transfers, and accelerates organisational learning to make internal teams more effective, not redundant and that is what Pharma Access aims to do with their facilities.

Q: What makes Pharma Access different when working? 

A combined focus on validated facility delivery, CQV, modular construction, and data-ready architectures to meet regulatory expectations while enabling modern manufacturing. 

Q:How do Pharma Access’s modular and digital-ready facilities reduce biotech project risks?

By reducing human error and enhancing cybersecurity in automated projects as well as catching defects faster, Pharma Access’s facilities help reduce biotech risk.

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The Future of Pharma Manufacturing: Automation, AI & Smart Facilities

The Future of Pharma Manufacturing: Automation, AI & Smart Facilities

Pharma manufacturing no longer includes giant steel vats and rows of workers in white coats.Given that it is no longer optional, demand and regulation are rising, margins are constantly under pressure, and there is an urgent need for pharma manufacturing solutions to ensure resilience following the COVID-19 supply chain shocks. 

Given this scale, industry analysts expect the global pharmaceutical market to reach about $1.9–$2.0 trillion in the mid-to-late 2020s. Regulators and customers now demand faster supply, tighter traceability and higher quality, all without extreme increase in price. That pressure is accelerating change, driven by three key factors.

Automation reduces manual variation and limits contamination, AI converts data into timely decisions, and smart facilities connect them all together. 

The rest of this article will explain how those three areas are already changing the way that drugs are made, and what it takes to deploy them safely.

Automation Revolutionises Pharmaceutical Production

Automation has evolved from mechanised filling lines and barcode readers to a much deeper reconfiguration of how a product is transformed from raw material to finished dose. 

Robotics and Sterile Operations: 
Robots now operate inside classified cleanrooms, performing tasks that once required repetitive human handling. These include vial filling, sterile transfers, precision pipetting, and automated inspection. Robotics reduces exposure risk for staff and lowers contamination opportunities that cause rejects. 

Continuous Manufacturing: 

Continuous manufacturing replaces discrete batch steps with an uninterrupted process flow. 

That matters for several reasons: there are fewer hold steps, faster throughput, and a much smaller inventory footprint. Regulators have taken notice: the International Council for Harmonisation and the USFDA have issued guidance (ICH Q13 and the FDA’s continuous manufacturing guidance) to help companies implement and validate continuous approaches.

Experts have reported outcomes for continuous systems that include substantial reductions in manufacturing time and notable cost efficiencies.. The USFDA has now approved several drugs manufactured with continuous approaches.

Let’s break down the key benefits of automation in pharma:

  • Quality Consistency: Every tablet or vial meets identical specs. 
  • Cost Reduction: Estimates suggest that automation can increase cost efficiency. 
  • Speed: Automated production lines run 24/7, increasing output exponentially.
  • Safety: Robots handle toxic or sterile materials, protecting workers as mentioned on Good Manufacturing Practices: Sterile & Aseptic Processing – Pharma Access 
  • Compliance: Automated documentation and electronic batch records make audits less of a headache, and reduces human error.

So, the takeaway is that automation doesn’t just cut headcount; it boosts quality, trims costs, and reduces human error in one of the world’s most demanding industries.

Artificial Intelligence Applications Transform Manufacturing Operations

If automation is the hands on the wheel, AI is the navigation system. Artificial intelligence turns raw sensor data and processes data into decisions, sometimes in milliseconds, a speed humans cannot match, which some call a boon in this industry despite the debates on AI’s environmental impact.

1. Predictive Maintenance: 

Breakdowns cost money. Sensors on machines (vibration, temperature, acoustic signatures) can be linked to AI models that predict part failure in advance. McKinsey estimates that predictive maintenance programs can increase machine uptime. and extend asset life when well executed, both of which add up to fewer lost batches and a more reliable supply. 

2. Accelerating Formulation and Discovery: 

AI has long been mainstream in early drug discovery. Now, AI-assisted candidate selection and design are a feature of the landscape, with major AI-focused drug discovery companies entering into collaborations with large pharma (Sanofi among them) to drive next-generation screening. These collaborations have led to milestone-driven progress and shown that AI-assisted screening can substantially shorten early cycle timelines relative to empirical screening. 

3. Smarter Quality Control: 

Vision systems run by machine learning algorithms inspect tablets, vials, and packaging with far more consistency than humans. Industry groups and technology vendors report higher rates of micro-defect detection with these systems; the result is fewer recalls and a higher assurance that only compliant products reach patients. 

4. Business Impact: 

AI can reduce unexpected stoppages with pharmaceutical quality systems. It can identify quality drift much earlier and speed up design decisions. Successful companies combine models with strong data governance policies so decisions can be traced and audited — a prerequisite for regulator acceptance.

Here is why AI applications matter in pharma:

  • Real-time Decision Making: Adjusts processes instantly.  
  • Pattern Recognition: Spots trends and anomalies before humans notice.  
  • Resource Optimisation: Allocates resources like energy, raw materials, and labour more effectively. 
  • Risk Mitigation: Identifies potential issues before they snowball. 

Smart Facilities: The IoT-Connected Pharmaceutical Future

Once you connect and measure everything, you end up with a facility that responds rather than reacts.

1. IoT and Live Monitoring: 

Thousands of networked sensors log temperature, humidity, differential pressure, particle counts, and utilities use, among other inputs. Real-time monitoring replaces periodic manual logging with continuous assurance. This is not a hypothetical example: leading manufacturers report real-world benefits like improved visibility and faster corrective actions when instrumenting their sites. 

2. Digital Twins:

Digital twins are software replicas of equipment or entire production lines that run in parallel with the real plant. Engineers can simulate changes to airflow, capacity, or process parameters without disrupting the real facility. Several large companies have piloted digital twins for vaccines or biologics production to speed troubleshooting and optimize throughput. 

3. Connected Cleanrooms: 

The modern cleanroom pipeline will also include automated access controls, environmental monitoring, and event logging that all feed a single operations dashboard. This means a faster response to particle count spikes or HVAC faults that could impact a process. 

4. Regulatory Considerations for Advanced Manufacturing Technologies

Advancing technology poses two simple questions for regulators: can the process consistently produce a safe product, and can it be proven? Answering those questions requires discipline. Turnkey Project for Aseptic Facility in Tunisia 

5. Validation and Explainability: 

AI models can improve operations, but regulators will demand traceability. “Black box” models that make decisions that cannot be explained and fail batches present validation challenges. For this reason, many companies apply AI but also build in rule-based checks and maintain a strict versioning and training data log so a model’s behaviour can be reviewed in an audit. 

6. Data Integrity and Cybersecurity: 

Digital systems have more entry points. Regulators demand strong controls over electronic records. Cybersecurity must be part of facility design (authentication, telemetry encryption) because an attack that tampers with sensor data could have safety implications. 

7. Regulatory Programs and Guidances: 

Regulators are adapting: The USFDA’s Emerging Technology Program and ICH Q13 have elements that support the adoption of continuous manufacturing when science-based controls exist. EMA and other agencies are working on positions related to digital tools, and regulators have been receptive to industry pilots that include robust data packages. 

8. Practical Approach: 

Success requires early regulatory engagement, thorough validation plans and documentation that ties technology behavior to product quality attributes. That makes approvals more straightforward and reduces surprises down the line. 

How Pharma Access Supports Manufacturing Transformation

Pharma Access is at the forefront of this revolution, not merely observing but actively facilitating it. Our portfolio of cutting-edge pharma infrastructure solutions empowers manufacturers to smoothly transition from traditional, outdated methods to future-ready smart facilities with zero downtime.

Here’s how PharmaAccess enables transformation:

  • Automation Integration – Adoption of robotics, continuous manufacturing systems, and other automation tools for greater throughput. 
  • AI-Enabled Systems – Predictive maintenance, AI-driven quality control and drug formulation support.  
  • Smart Facility Design – Connected cleanrooms, digital twin simulations and IoT-driven monitoring systems that comply with global standards. 
  • Compliance Support – Validation, auditing and documentation for USFDA and other global regulatory agencies. 

In short, PharmaAccess equips companies with the tools, resources, and support they need to remain competitive, compliant, and resilient in an industry where the future has no patience. 

The Roadmap to Pharmaceutical Manufacturing’s Future

The transformation of pharmaceutical manufacturing is both inevitable and actionable. Automation reduces human variation and contamination risk with pharma engineering turnkey solutions. AI turns data into timely and auditable decisions, and smart facilities give leaders the visibility to run complex facilities reliably by turnkey clean room solutions for pharma. Regulators are not trying to stand in the way of this change; rather, they are setting science-based frameworks to allow proven systems to scale.

For manufacturers and supporting infrastructure partners, the practical steps going forward are clear: 

  • Assess Data Readiness. Inaccurate data wrecks even the best AI models. 
  • Start with high-value pilots. Predictive maintenance or a single continuous line are good, manageable places to start.
  • Design for validation.  Traceability, explainability, and cybersecurity should be built into systems from the beginning.
  • Train the people, not just the machines. Upskilling the workforce is not optional.
  • Engage regulators early. Transparency shortens approval cycles.

The pharma manufacturing of the near future will be faster, cleaner, and more predictable. It will not eliminate the need for skilled operators and quality scientists, but it will change how they spend their time, hopefully moving them from repetitive tasks to high-value problem-solving. 

For companies that act, invest wisely, and work with regulators, the upside is stable supply, cost efficiencies, and better patient outcomes. For those who don’t, the gap between leaders and followers will only grow wider.

Are you ready to move from talking to implementation? The technology and regulatory frameworks are there; the next step is practical project design and disciplined execution. 

Frequently Asked Questions

1. Why is automation a big deal in pharma manufacturing? 

Automation reduces human error, enhances efficiency, cuts costs, and maintains consistent quality, all critical in an industry where lives are on the line. 

2. How is AI enhancing pharma manufacturing?

AI is enabling predictive maintenance, faster drug formulation, and more rigorous quality control measures by crunching and analysing data sets that are simply too large for humans to process in a meaningful time frame. 

3. What exactly are smart facilities in the pharma industry?

Smart facilities are completely integrated and monitored environments for pharmaceutical operations. They use IoT, digital twins, and connected cleanrooms to provide a safe, compliant, and sustainable ecosystem for pharmaceutical manufacturing. 

4. What are the challenges associated with these technologies?

Regulatory compliance, validating AI systems and algorithms, the initial capital investment, and retraining the workforce are some of the challenges that companies could face when implementing these solutions. 

5. How can PharmaAccess assist manufacturers in this transition?

Pharma Access is a one-stop solution for infrastructure, smart facility solutions, automation systems, and compliance support to help manufacturers seamlessly adopt the latest technology without disrupting current operations. 

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Manufacturing Execution Systems in Pharma

Manufacturing Execution Systems in Pharma
  • Manufacturing Execution Systems in Pharma

What is it for?

Pharmaceutical manufacturers are eliminating the use of paper batch records in favor of electronic batch recording. Manufacturing Execution Systems (MES) facilitate manufacturers to improve performance and reduce operational cost, while simultaneously increasing compliance with regulatory requirements.

The MES plays a critical role at the center of the manufacturing operation, connecting shop floor personnel, equipment automation, logistics, sales and planning. Its ability to align these different functions and provide visibility to key stakeholders drives performance and compliance across the organization.

Do i need it for my manufacturing plant?

Executives at manufacturing companies of all sizes need to make decisions about where to invest to maintain and grow their businesses. Investments in manufacturing execution system (MES) applications may reduce costs and increase revenues, but they also might compete with other investment priorities, such as marketing campaigns and capital equipment upgrades.

In this article we will explore together the benefits of MES & evaluate an investment in MES versus other alternatives.

Manufacturing Execution System

What are the advantages?

Manufacturing Execution Systems offer substantial improvements over paper based processes. They help pharma manufacturers create flawless manufacturing processes, reduce risks, time, costs and effort, and increase process efficiency and product quality. In addition, they provide valuable real time information on requirement changes. Nonetheless they are an important prerequisite for digitization and Pharma 4.0..

Few areas of opportunities where MES can help reduce costs are as following:

Are there any revenue improvements?

Implementation of MES is shown to increase the revenue and benefit the manufacturer in the following ways:

  • Greater Asset Productivity: MES allows more saleable product to be made in the same time on the same equipment, the margin of that incremental product shall be considered a cash inflow
  • Faster Better decisions: Uncertainly about the disposition of a product can cause it to sit in a warehouse or delay shipment. Quicker resolution of such issues saves money and could lead to faster realization of revenue
  • Reduced working capital: Keeping material around when it is not immediately needed for production or sale is wasteful. These materials take up space and money. Eliminating them frees up working capital-money, space, or effort that would be spent dealing with these items can instead be used elsewhere
  • Better compliance profile and inspection results: Fewer nonconformances and manual errors reduce the risk of regulatory scrutiny and subsequent regulatory actions
  • Customer retention due to improved cost and quality: MES implementation retains a customer that would likely be lost given the current state, the retention can be considered an incremental cash in flow.
  • New sales or better support for sales growth: For a plant in a sold out position, every additional unit that can be produced is a cash in flow of the margin of that unit.

What do we conclude

Implementation of MES is shown to increase the revenue and benefit the manufacturer in the following ways:

  • For existing facilities: For existing production facilities, the operational justification for the MES is typically based on quality and patient safety needs such as non conformances, CAPAs, audit observations, as well as business needs such as expansion plans, process/product changes, and overall business agility to meet unknown demands.
  • For greenfield facilities: For new operations, using an approach such as failure modes and effects analysis (FMEA) can identify risks that can be mitigated by implementing MES applications.

Conclusion

The decision to invest in MES applications should be driven by sound economics, based on real costs and benefits. The costs and benefits considered should be incremental, representing changes from what would happen anyway (the current state or base case) or, in the case of alternatives, real cash flow differences between the options.

With the right MES, pharmaceutical and biotech manufacturers can reduce time, efforts and risks and finally save costs provided that the system meets the requirements of the pharmaceutical industry in terms of functions, usability and compliance. Connect with us at sales@pharmaaccess.net to know the best practices for your facility!