The ability of the biopharma industry to meet the worldwide demand for messenger RNA vaccines was facilitated by contract development and manufacturing organizations. These partners promptly adapted their facilities and capabilities specifically for vaccine production, offering contract fill/finish and cold chain services required to meet demand. Examining the lessons learned from the COVID-19 pandemic, this article provides a perspective on the strategies and tactics taken to deliver a better drug development program and highlights the importance of remembering key lessons as the industry moves toward an era of new drug modalities.

Pharmaceutical Technology’s February 2023 Outsourcing Innovation eBook

Jeong Jin-hyeok is a lead specialist in drug product at Samsung Biologics.


eBook: Outsourcing Innovation, February 2023
February 2023
Pages: 30–32

When referring to this article, please cite it as J. Jin-hyeok, “Preparing for a New Wave of mRNA Technologies," 

Pharmaceutical Technology Outsourcing Innovation

Articles

Manufacturing

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Preparing for a New Wave of mRNA Technologies

Advanced therapeutic medicinal products (ATMPs) are experiencing a boom, with the global pipeline continuing to experience growth and more than 3700 ATMPs currently under development, according to data from the American Society of Gene and Cell Therapy. However, progressing such complex therapies that target niche disease areas through to commercialization produces a unique set of challenges.

Critically, the technical expertise required for the clinical research of ATMPs is something that can be lacking for developers in-house, driving demand for contract research organizations (CRO). In fact, the cell and gene therapy CRO market is forecast to experience continued and consistent growth until 2035.

In this feature, Rhonda Henry, president of Emmes BioPharma; Ching Tian, chief innovation officer, Emmes; and Raja Sharif, CEO Hataali, detail the challenges facing biopharma companies developing ATMPs and the role that CROs play in gaining a market advantage.

Pharmaceutical Technology's February 2023 Bio/Pharma Outsourcing Innovation eBook

Felicity Thomas is European/senior editor for Pharm Tech Group

When referring to this article, please cite it as Thomas, F. CROs Gaining a Competitive Edge. 

Pharmaceutical Technology's Bio/Pharma Outsourcing Innovation eBook 

Outsourcing

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

CROs Gaining a Competitive Edge

Historically, in the early days of bioprocessing, the use of outsourcing to a contract manufacturer had been considered a less-than-optimal way to build a biopharmaceutical company. However, as attention has shifted toward improving efficiency, this has changed. The biopharmaceutical industry has increased its reliance on contract manufacturers over the past decade for a variety of reasons.

One of the factors increasing the demand for contract development and manufacturing organizations (CDMOs) and greater outsourcing is the industry’s focus on productivity and efficiency. Some operations and bioprocessing activities can simply be done more effectively by organizations that specialize in those operations. As the industry has become more complex, with increasingly advanced technologies, such as cell and gene therapies, in some cases, the need for the skills available from specialized CDMOs is indispensable. According to the 19th
Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates in 2022 (1), 65% of biomanufacturers today outsource at least some of their bioprocessing. This compares with only 42% outsourcing in 2006.The trend over the past 17 years has been very consistent—each year fewer facilities are relying solely on their in-house capabilities.And over the next five years, this trend will continue, with 79% of respondents indicating they plan to outsource at least some of their operations by 2027 (1).

Read this article in the Bio/Pharma Outsourcing Innovation 2023 eBook

Shriya Bhatkhande is a research associate at BioPlan Associates.

When referring to this article, please cite it as S. Bhatkhande, " Biopharmaceutical Manufacturing Growth," 

Pharmaceutical Technology's Bio/Pharma Outsourcing Innovation

Growth in outsourcing has been the result of COVID-19 projects taking 
precedence, which has pushed some contract manufacturing to second-tier CDMOs. 

Biopharmaceutical Manufacturing Growth

The pace of quality transformation in life sciences continues to accelerate as global pharmaceutical companies and fast-growing biotechs look to simplify and automate complex processes. Investments in technology
are expected to continue well beyond 2023, with the quality management systems (QMS) market forecasted to grow at a 10% compound annual growth rate until 2030 (1).

Industry leaders are driving positive change and charting the path toward unified quality processes that bring together people, partners, and systems. For example, The Center for Breakthrough Medicines is a contract development and manufacturing organization (CDMO) that adopted advanced quality solutions to support its vision of building the world’s largest cell and gene therapy manufacturing and testing facility (2).

However, more work remains to stay ahead of evolving market conditions, regulatory requirements, and customer expectations. A continued commitment to driving innovation will be critical for companies to keep up with industry changes and deliver new therapeutics to patients morequickly while mitigating risks. In this article, four key trends that will shape the future of quality and manufacturing are identified, examined, and discussed.

Ashley Wentworth is senior director, Vault Quality, at Veeva Systems.


eBook: Outsourcing Innovation, February 2023
February 2023
Pages: 10–11

When referring to this article, please cite it as A. Wentworth, “Forecasting Trends in Pharma Innovation" 

Quality

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

Forecasting Trends in Pharma Innovation

The relationship between pharmaceutical companies and the contract organizations that perform development and manufacturing services comes with the necessary process of transferring intellectual information, processes, and product from one organization to another. Complex products such as biologics and messenger RNA (mRNA) vaccines come with additional challenges during the tech transfer process.

To gain more insight on the complexities of transfer of pharmaceutical technology between contractors and sponsors, 

® spoke with Petra Dieterich, scientific leader, and Jeffrey Mocny, scientific leader-Early Development, both with Abzena; Peter Ercoli, chief operating officer, Biologics, at BIOVECTRA; Deepak Thassu, PhD, MBA, senior vice president, R&D and Regulatory Submission, at LGM Pharma; Emma Rhodes, head of New Product Introduction at Sterling Pharma Solutions; Sara Schemel, senior process engineer, Dona York, principal process engineer, and Gauri Patki, senior process engineer, all at Catalent Biologics; Uwe Hanenberg, PhD, head of Product Development at Recipharm; and Rebecca Powell, associate director, Tech Transfer at Arranta Bio, a Recipharm company.

When referring to this article, please cite it as S. Haigney. Communication is Key in Complex Tech Transfer. 

Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation 

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Communication is Key in Complex Tech Transfer

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With advancements in research and technologies, the diversity of biological drugs available is broad, including monoclonal antibodies (mAbs), prophylactic vaccines, gene therapy viral vectors (mainly lentivirus and adeno-associated virus), cell therapies (e.g., chimeric antigen receptor T-cell therapy and modified stem cells), and oncolytic viruses (e.g., adenoviruses, herpes viruses, and vaccinia virus).

As a result, the bioreactor vendor and contract development and manufacturing organization industries are under pressure to increase production scale. To meet demand, these industries must feasibly scale up while considering safety, manual operator handling, engineering, infrastructure, costs, and finally biological processing itself.

Kai Lipinski, PhD, is the chief scientific officer of Vibalogics.

When referring to this article, please cite it as Lipinski, K. Scaling Manufacturing Processes Using Single-Use Technologies. 

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling. 

Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation, February 2023

Preparing for a New Wave of mRNA Technologies

CROs Gaining a Competitive Edge

Biopharmaceutical Manufacturing Growth

Forecasting Trends in Pharma Innovation

Communication is Key in Complex Tech Transfer

Scaling Manufacturing Processes Using Single-Use Technologies