Pharmaceuticals Manufacturing - Frost & Sullivan

[Pages:20]Pharmaceuticals Manufacturing

The power of data and market trends impacting pharmaceutical manufacturing and R&D facilities

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Contents

1. Executive Summary......................................................................................................................... 3 2. Introduction ........................................................................................................................................ 4 3. Key Trends in Pharmaceutical Industry............................................................................................... 5

Rising Cost Pressure Propelling Growth in Outcome Based Reimbursement and Outsourcing......... 5 Quest for Novel Treatments Leading to Rise in Drug Complexity and Personalized Medicine .......... 5 Expanding Digital Footprint ................................................................................................................ 6 4. Focus on Pharmaceutical Manufacturing ? streamlining operations to enhance production efficiency ................................................................................................................................................. 7 Rapid Transitioning to Continuous Manufacturing............................................................................. 7 Technological Transformation Generates Huge Data-Related Growth Opportunities ...................... 8 Best Practice on Data Management and Data Storage .................................................................... 11 5. Focus on Labs ? Adopting Advanced Technologies such as Modular Manufacturing and IIoT to Boost Production .................................................................................................................................. 12 Rise in Modular Manufacturing ........................................................................................................ 12 Increasing Adoption of Industrial Internet of Things (IIoT) .............................................................. 14 Computerized Maintenance Management System Aiding 4.0 Manufacturing Transition ............... 18 Rising Adoption of Electronic Batch Records Accelerating Time to Market ..................................... 18 6. Conclusion.........................................................................................................................................19

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1. Executive Summary

? Rising payer pressure, the move towards more complex personalized medicine and increasing adoption of digital solutions are key trends shaping the global pharmaceutical industry

? To align themselves to the global trends, pharmaceutical companies are optimizing their operations. Adoption of continuous manufacturing and a complete technological transformation are the needs of the hour.

? 2017 witnessed multiple regulatory updates pertaining to data management, security, access and validation.

? Pharma companies are actively partnering with specialist providers to enhance data security and validation, especially in cloud.

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2. Introduction

The global pharmaceutical industry is witnessing a surge in CEO confidence from US tax reforms, turbulent equity markets, and the strengthening global economy. The growth of the pharmaceutical industry is boosted by healthcare digitalization and democratization, creating an explosion in patient data, and the emergence of value-based reimbursement models. The convergence of biopharmaceuticals, drug delivery devices, and companion diagnostics--enabled by digital connectivity--is driving regulatory and commercial changes in many exciting ways for the industry. Recently, the US Food and Drug Administration (FDA) released several guideline documents, which are likely to increase the adoption of digital technologies in pharmaceutical manufacturing. These guidelines provide frameworks for electronic submission of clinical data and manufacturing establishment information, while laying down expectations for maintaining data integrity and compliance with good manufacturing practices (GMP). This has encouraged pharmaceutical companies to adopt advanced processes such as Industrial Internet of Things (IIoT), modular manufacturing, electronic batch record systems and computerized maintenance management systems that employ sensors and advanced analytics. The objective of this paper is to outline the key transformational trends in the pharmaceutical industry and assess their impact on pharmaceutical manufacturing and research and development (R&D) facilities. The paper tracks the various strategies adopted by pharmaceutical companies to enhance their manufacturing capabilities and technological footprint ? with a special focus on labs. It aims to demonstrate the role that improved building management solutions can play in achieving cost effectiveness, improving energy efficiency, and boosting the sustainability of the pharmaceutical industry's production processes.

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3. Key Trends in Pharmaceutical Industry

The pharmaceutical industry is facing a number of key challenges and transformational changes that will determine its future development: Rising costs, the move towards more complex personalized medicine and the increasing adoption of digital solutions are all key trends shaping the industry.

Rising Cost Pressure Propelling Growth in Outcome Based Reimbursement and Outsourcing Globally, governments are struggling to meet the increasing demand for advanced treatments from an ageing population. The result is increased pharmaceutical expenditure which is forecast to increase by 6.5% per year to 2022, when global expenditure will exceed $1 trillion1.

Escalating drug prices have meant insurance providers and government agencies are focusing on outcome-based reimbursement of drugs. Governments are also encouraging the adoption of low cost biosimilars2, as alternatives, where possible, to costly biologic drugs.

The pressure to curb rising drug prices is forcing pharmaceutical companies to look at different avenues for increasing their operational efficiency and reducing expenditure. This is resulting in an increase in outsourcing, especially in the manufacturing of drugs. Due to evolving manufacturing practices, which requires the manufacturing of high value, low volume drugs, pharmaceutical companies are increasingly viewing Contract Manufacturing Organization (CMO) providers as strategic partners. They can assist in boosting their technical capability and provide manufacturing support across regions whilst also delivering the flexibility and reliability that the suppliers themselves would expect.

Quest for Novel Treatments Leading to Rise in Drug Complexity and Personalized Medicine To compete in a crowded market, pharmaceutical manufacturers are exploring novel biologic3 compounds and therapeutic targets. In 2017, the US FDA approved a record number of drugs (46 new approvals) of which, 22 were biologics.4 Pharmaceutical companies such as Roche, Amgen, Sanofi, AbbVie and Novo Nordisk are increasingly focusing on biologics due to a growing demand for innovative therapies and rising patent cliffs. Consequently, the ability to rapidly ramp-up production facilities is a key success factor.

1 Frost & Sullivan 2 A biosimilars is a copy of an approved biological drug (see footnote below) in the market. Biological drugs are protected for a certain period of time through patent laws, which prevent any company to make a copy of them. However, once patents expire, companies are free to make biosimilars, and launch them at a lower price to the biological drug. Biosimilars are clinically demonstrated to be similar and interchangeable with approved biological drug. 3 Biologic drug is a medicine that has been made using a living system such as a cell or a microorganism. It is generally a large and complex molecule. E.g. insulin, blood component, vaccine etc. 4 US FDA

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Expanding Digital Footprint Initially considered as a laggard, the global pharmaceuticals industry is catching up on the adoption of digital solutions. Digital data is transforming operations across the pharmaceutical value chain, right from drug discovery to post marketing surveillance. The adoption of digital sensors in clinical trials is on the rise. They are being used to analyze patient data and help in patient recruitment and retention. They are also being utilized for tracking patient experience in clinical trials and guiding trial design.

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4. Focus on Pharmaceutical Manufacturing ? streamlining operations to enhance production efficiency

The pharmaceutical industry is navigating a challenging path. It needs to improve operational efficiency in order to reduce costs and protect margins, whilst also ensuring the quality and safety of pharmaceuticals. As part of achieving these goals, it must innovate and increase the utilization of digital solutions. However, all of this must be done within the frameworks provided by regulatory agencies, particularly to ensure that data is correctly recorded and securely stored at all points in the process, including the building's environmental conditions.

Rapid Transitioning to Continuous Manufacturing The need to manufacture drugs cost effectively, in a safer, faster and more sustainable manner is propelling pharmaceutical companies to gradually transition to continuous manufacturing processes, meaning that pharmaceutical buildings must be operational 24 hours per day, 365 days per year.

Currently, most drugs are manufactured using batch processing, which involves multiple steps. Product is collected after each step, evaluated for different parameters conforming to quality, before using it as a raw material for the next step.

Continuous processing, on the contrary, uses a continuous stream of raw materials, furnishing finished products at a constant rate. Through the use of sensors, an active feedback mechanism reduces the need of manual handling, increasing overall safety in production. The process results in less waste, leading to a lower ecological footprint, reduced inventory and lower capital costs, making the process cost effective.

Regulatory stance

Regulatory agencies are encouraging manufacturers to transition to continuous manufacturing. The FDA was one of the first regulatory agencies that recommended adoption of continuous manufacturing.

"Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing." Janet Woodcock, Director, FDA Center for Drug Evaluation and Research

The European Medicines Agency (EMA) adopted a similar stance and recognized that continuous manufacturing dossiers are likely to be more complex. It recommended early dialogue with the agency, especially for legacy products transferred from batch to continuous manufacturing. The agency supports the industry through scientific advice, process analytical technology (PAT) teams, subject matter expert office, and the Innovation Task Force. As per the EMA "The current regulatory framework is adequate to allow

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continuous manufacturing. No specific guideline currently available, but existing guidelines are supportive."

Case examples

Vertex was the first pharmaceutical company to get approval for using continuous manufacturing in 2015 from the FDA and EMA, for its fixed-dose combination tablet product, Orkambi, used for the treatment of cystic fibrosis. Janssen's tablet for treating HIV, Prezista was the first supplemental FDA approval (2016) for changing from an established batch process to a continuous manufacturing process. It resulted in a significant reduction in operational requirements, with the usage of 2 rooms instead of 7 for batch process. Also, production timelines were reduced to 1 day, instead of up to 2 weeks for batch.5

Challenges and solutions

One of the most significant challenges was being able to determine the clinical efficacy of an active ingredient online. This has changed with the emergence of highly specialized technological tools and software solutions that enable data collection directly in the process. Tools for analysis improve the manufacturer's understanding and control of the process, increase process quality and reduce the risk of losing products due to nonconformity. This increases the utilization of operational assets by 30% to 40%; and a product that previously took one or even two months in production is finished in a few days. Ensuring proper control of room assets is vital to achieving these efficiency gains. HVAC systems and other process equipment must be optimized to ensure peak operational performance.

Technological Transformation Generates Huge Data-Related Growth Opportunities Pharmaceutical companies are facing unprecedented growth in data. Pharma's transition from paper to digital, across the value chain, has added a tremendous volume of data to its IT system. With rising usage of sensors in production and in the building, as well as the adoption of Industrial Internet of Things (IIoT) practices in manufacturing, the volume of data generated is expected to register an exponential growth.

To encourage innovation and increase adoption of new technological solutions, regulatory agencies are proactively providing guidance to the industry. Recently, the FDA has released several guideline documents, all of which indicate more reliance on electronic data.

Regulatory updates

Recently released documents by the FDA to steer the pharmaceutical industry towards optimized use of data, included the following:

5 Global DataPoint

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