TURNKEY MANUFACTURING IN THE BIOPHARMACEUTICAL INDUSTRY

Biopharmaceutical Industry Insights: Now and Next

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Biopharmaceuticals are one of the most advanced and distinguished domains in modern scientific endeavours. It encompasses enterprises engaged in the research, formulation, production and distribution of therapeutic products. Valued at an estimated market size of USD 516.79 billion in 2024, this sector is projected to grow to USD 761.80 billion by 2029 ?— ?a compound annual growth rate (CAGR) of 8.07% throughout the forecast period (2024-2029).[1 ]

?Biopharmaceuticals are characterised by large and structurally intricate molecules derived from living organisms — humans, animals, microorganisms, or plants. They offer powerful therapeutic solutions across a spectrum of medical fields, including oncology, immunology, endocrinology, cardiology and neurology. The remarkable efficacy and safety profiles of biopharmaceutical products combined with their ability to treat previously untreatable conditions have raised the bar for therapeutic interventions. Their success and potential have driven a surge in demand for these products and compelled even traditional pharmaceutical companies to diversify their operations and invest in biopharmaceutical development and production.

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Pioneering Breakthroughs for a Healthier Tomorrow

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The extensive array of therapeutic innovations, including treatment modalities such as CAR T-cell therapy, mRNA vaccines, Monoclonal antibodies (mAbs), Cell and gene therapy, biologics, precision medicines, and regenerative medicines highlight the breadth and depth of research activity within the biopharmaceutical field.

?Omics technologies, encompassing genomics, proteomics, metabolomics, and other related fields provide comprehensive insights into biological systems and have played a transformative role in the discovery, development, and manufacturing of safe and effective personalised medicine.

?Innovative technologies such as Single-Use Technologies (SUTs), continuous manufacturing, Advanced Process Control (APC), Process Analytical Technology (PAT), automated bioprocessing, scalable modular manufacturing systems, high throughput screening, artificial intelligence, machine learning, 3D printing, digital twins, etc. have enhanced manufacturing efficiency, scalability and quality control — accelerating time-to-market for new therapies.

?The rapidly expanding pipeline of innovative treatments promises to address a broad spectrum of previously untreatable health conditions. The dynamic interplay between research and development efforts, combined with the increasing investment in sophisticated biotechnological tools, is fostering an environment where novel therapeutic approaches can flourish.

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Navigating Biopharma’s Complex Value Chain

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Despite its growing popularity, the biopharmaceutical industry faces numerous challenges spanning drug discovery, development, process optimisation, stability studies, manufacturing, clinical trials and regulatory compliance, all of which impact the efficient and cost-effective market introduction of innovative therapies.

?The delicate nature of biological products, typically sensitive to shear and heat, necessitates maintaining stringent sterility and scalability measures in biopharmaceutical processes. Moreover, continuous process improvement for biological cells, high-yield expression systems, stable cell lines, media selection, robust quantification methods, contamination control, scalability, cost and time efficiency, and product stability pose significant bottlenecks.

?Global product development is further complicated by varying regional regulatory requirements, extensive documentation, and clinical trial data demands to ensure safety and efficacy. The expiration of patents on biologic drugs introduces competition from biosimilars, impacting revenue streams. Supply chain disruptions and non-sustainable sourcing of raw materials lead to production delays and inconsistencies. Additionally, the necessity for strict temperature controls during storage and transportation increases logistical complexities and costs.

?Integrating new technologies such as AI, machine learning, and digital health solutions requires substantial investment and expertise. Consumer pressure to reduce drug prices further affects profitability.

?Addressing these challenges requires strategic planning, investment in innovation, industry-wide collaboration and effective engagement with regulatory bodies and stakeholders.

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Turnkey Projects: The Key to Efficient Biopharmaceutical Manufacturing

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Manufacturing biopharmaceuticals is capital-intensive, with infrastructure and operational costs forming a large portion of product expenses.?Turnkey project management offers a streamlined approach to complex projects, delivering comprehensive expertise from concept to completion for greenfield and brownfield projects. By integrating design, engineering, procurement, construction, commissioning and validation, turnkey solutions ensure optimal outcomes, adherence to stringent regulatory standards, and accelerated project timelines. The collaborative approach under a single umbrella allows manufacturers to address gaps in timelines, specifications, equipment, and process integration. This approach optimizes costs, reduces management challenges and mitigates risks, enabling biopharmaceutical companies to focus on their core competencies — improving patient outcomes.

Accelerate Biopharma Production with DDE's Turnkey Solutions

DDE is a leading turnkey solution provider that is redefining the boundaries of high-purity manufacturing. We offer comprehensive design, construction, automation, digitalisation, and qualification services for multinationals as well as renowned research institutes in the fields of biopharmaceuticals, vaccines, and sterile formulation.

Backed by 46+ years of experience and a team of over 600 researchers, engineers, technicians, designers and technology specialists, we tackle the industry’s toughest challenges by providing scalable, flexible, robust and high-quality bioprocess solutions for turnkey projects — both greenfield and brownfield.

Our rigorous project management and execution adhere to strict regulatory guidelines?( Operon Strategist|Medical Device Project Consultant|CE MarkConsultant | USFDA | FDA Consultant , World Health Organization , MHRA, EU, TGA, ANVISA, cGMP). We deliver modular state-of-the-art equipment, complete with comprehensive installation protocols and documentation. Our systems seamlessly integrate with leading automation platforms (Siemens, Rockwell, Emerson) for optimal performance.

Among our recent endeavours is a groundbreaking project involving the development and implementation of a cultivated meat bioreactor system in the United States; the provision of upstream, downstream and fill-finish equipment for a blood plasma facility; and the supply of upstream, downstream and fill-finish equipment for an insulin production plant. Additionally, we have executed an MDI project in Morocco and established a complex injectable facility in India. DDE has also collaborated with biologics companies/vaccine manufacturers?during the COVID-19 pandemic, facilitating the rapid scale-up of modular COVID-19 vaccine plants. ?

DDE's expertise in smart planning, strategic coordination, and precise execution enables us to deliver customised, scalable solutions for manufacturing products in a sterile environment.?Our commitment to quality and excellence empowers biopharmaceutical companies to deliver innovative solutions that accelerate time to market and improve patient health. Through our deep industry expertise and agile approach, we optimise operations and drive sustainable growth, ensuring that life-changing therapies reach patients faster.

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Source:

1. https://www.mordorintelligence.com/industry-reports/global-biopharmaceuticals-market-industry