Key challenges for bio/pharmaceutical manufacturing 2022 (2022)

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Posted: 19 January 2022 | Hannah Balfour (European Pharmaceutical Review) | No comments yet

What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.

Key challenges for bio/pharmaceutical manufacturing 2022 (1)

Supply and demand

Even before COVID-19, the outsourcing of biopharmaceutical development and manufacturing was growing; particularly as increasing numbers of small and virtual biotechnology companies were adopting business models fully reliant on outsourcing all development and manufacturing activities.

With materials such as glass vials being prioritised for vaccine production, biopharma manufacturing companies have not only had to navigate supply delays due to workers isolating but also consumables shortages”

(Video) Meeting Emerging Biopharmaceutical Manufacturing Challenges

To meet global demand for vaccine and therapeutics doses, a significant proportion of the production of COVID-19 vaccines and treatments was outsourced, with more than 230 manufacturing agreements having been publicly disclosed to date between COVID-19 vaccine and therapy developers and contract manufacturers.1

James Choi, Executive Vice President and Chief Information & Marketing Officer and Head of Global Public Relations and Process Improvement at Samsung Biologics, explained: “The COVID-19 pandemic has been one of the greatest challenges globally for biologics manufacturing to date and has been unrelenting since its onset. As a result of the pandemic, CDMOs have seen an increasing demand to deliver drugs to market at an unprecedented speed. The requirement for regular booster vaccinations means that this need for manufacturing support will likely continue for the foreseeable future.”

Other supply challenges include COVID-19-related supply chain disruption: “With materials such as glass vials being prioritised for vaccine production, biopharma manufacturing companies have not only had to navigate supply delays due to workers isolating but also consumables shortages. Many materials required for biopharma manufacturing have seen delays of six to 12 months, as well as having a higher cost due to increased demand,” stated Bill Vincent, Founder of Genezen. He added that, due to such disruptions, it has become increasingly important for companies to predict supply with high accuracy, raise inventory levels and qualify alternative suppliers to minimise shortages.

it has become increasingly important for companies to predict supply with high accuracy, raise inventory levels and qualify alternative suppliers to minimise shortages”

Another supply challenge for pharma is the increasing pressure for sustainable sourcing, according to a recent report by CPhI and Baxter.2 In the report, Manjit Singh, Chair of the Pharmaceutical Supply Chain Initiative (PSCI), stated: “Companies are setting out a path via their procurement policies and practices to ensure a deep understanding of the supply risk emanating from environmental issues like climate change and antimicrobial resistance (AMR), social issues like human rights and ethics, and their potential economic impacts.” According to Singh, sustainable sourcing aims to improve the ethical, environmental and social performance of suppliers, thereby mitigating any negative impacts within the supply chain. This could have a significant impact on bio/pharmaceutical manufacturing.

Novel therapeutics

According to Choi, the challenge of demand is exacerbated by another factor: the need to adapt to novel technologies, including messenger RNA (mRNA) vaccines and therapeutics.

mRNA

“Adapting to new and previously unfamiliar technologies, including mRNA, has been a substantial learning curve for many CDMOs,” commented Choi, adding that adjusting capabilities, investing in capacity and embracing these new technologies is now critical to success.

Choi explained: “The use of mRNA technologies in the production of vaccines in response to COVID-19 has demonstrated the effectiveness and potential of the technology. The capability for mRNA to be easily edited not only makes it the ideal tool to combat viruses that can quickly mutate, but also gives it the potential to be used in the treatment of countless other diseases. This is highlighted by the fact that there were over 70 mRNA therapeutics in clinical pipelines globally as of July 2021, and there are many more assets currently in early development.3

“CDMOs must not only familiarise themselves with this technology quickly but also be fully equipped with the right capacity and capabilities, as demand for manufacturing support for mRNA products is set to increase further.”

(Video) 2022-2023 Global Pharmaceutical Biotech Industry Spending Outlook Webinar

Cell and gene therapy

Key challenges for bio/pharmaceutical manufacturing 2022 (2)

mRNA is not the only key emerging therapeutic technology: 2021 has been heralded by some as the year of cell and gene therapy, with many advancements in the field. However, being such a new technology, developments in their manufacturing process is ongoing to ensure production can safely meet demand. According to Vincent, one technology set to be influential for cell and gene therapy manufacturing is the use of stable producer cell lines that can grow in suspension. Particularly important for lentiviral vector manufacturing, “having stable cell lines will eliminate the need for transient transfection as part of each production run, leading to reduced material costs while providing a more consistent product,”4 he commented. Additionally, Vincent said: “The ability of these cell lines to grow in suspension bioreactors will also mean that larger batch sizes can be achieved, which is essential for commercialisation.”

Vincent added that the development and adoption of stable producer cell lines is due to an anticipated challenge for the market: “As interest in cell and gene therapy grows, and the viral vector industry matures, a tightening of the regulations surrounding their manufacturing can be expected.

“Regulations are predicted to impact the use of serum in producer cell growth, as it cannot be guaranteed to be consistent in composition. Adherent 293T cells are hard to grow without foetal bovine serum (FBS) but there are currently not many serum-free media available to grow adherent cells. As a result, lentiviral vector manufacturers will need to start looking for alternative options, such as stable producer cell lines.”

Speed to market

Key challenges for bio/pharmaceutical manufacturing 2022 (3)

As mentioned by Choi, speed to market now represents a significant challenge for drug developers. According to the US Food and Drug Administration (FDA)’s latest report, 74 percent (34 out of 50) of the novel drugs approved by FDA in 2021 used some form of expedited development or review pathway, specifically Fast Track Designation (36 percent, n=18), Breakthrough Therapy Designation (28 percent, n=14), Priority Review (68 percent, n=34), and/or Accelerated Approval (28 percent, n=14).5

“The increasing pressure for speed to market is at odds with transfer delays as projects move between sites or companies to perform subsequent processes across the supply chain. These delays have been worsened by the effects of COVID-19. The ability to obviate these delays will continue to be a pivotal criterion in selecting a manufacturing partner,” commented Choi.

Frank Kogelberg, Director of Business Development, Contract Manufacturing at Baxter, also emphasised the importance of reducing transfer delays in the report by CPhI and Baxter.2

Skilled labour shortage

Vincent highlighted: “A key factor that will continue to impact biopharma manufacturing in the next year and beyond is the limited availability of skilled labour. Although some of the problems surrounding labour shortages could be solved using automation, the fundamental issue will remain. Preparing workers for the STEM (science, technology, engineering and mathematics) industries will require further funding in the education sector – and any territory (city, state or nation) ready to solve this challenge will be poised to dominate the industry.”

(Video) Biopharma 2022: What's Next?

To learn more about the potential future skills shortage, read our article: The weakest link – biopharma workforce development.

Poorly soluble HPAPIs

Manufacturers are addressing the challenges of HPAPI drug delivery and production by integrating new formulation and drug substance processing methods”

According to Lonza CHI’s Rose Mary Casados, Senior Director of Product Management Marketing, the primary challenge facing the manufacturing industry is delivering oral solid dosage (OSD) formulations containing increasingly poorly water-soluble highly potent active pharmaceutical ingredients (HPAPIs). Casados explained: “Treating cancer remains a key area of focus for all of global pharma and continues to drive a tremendous amount of development… Many oncology products use HPAPIs and innovators, and their contract development partners have seen an increase in the number of global development projects involving HPAPIs.”

Lonza predicts that advanced formulation and manufacturing techniques for HPAPI compounds will become better understood and integrated earlier in development through 2022, with innovations in capsule materials and engineering being particularly influential. Casados stated: “Manufacturers are addressing the challenges of HPAPI drug delivery and production by integrating new formulation and drug substance processing methods including lipid-based formulations (LBFs) and amorphous solid dispersions (ASDs).

“The need to deliver HPAPI and other complex compounds now under development is contributing to a shift towards encapsulating formulations in hydroxypropyl methylcellulose (HPMC). If an API is sensitive to water and/or formulated as an ASD, HPMC capsules can help control the effects of water relative to the API and formulation stability.”

Flexibility in manufacturing

Lynn Allen, Vice President of Business Development at MedPharm Ltd, explained how the rise of drug development for orphan and rare diseases is impacting the sector, increasing the importance of flexibility in manufacturing. “As drug development becomes more specified in the target indication, so does the patient population. End markets for orphan drugs or drugs that target specific subsets of a patient population reduce the size of a market for a product. This in turn reduces the size of manufactured batch requirements,” she stated. According to Allen, these smaller batch manufacturing requirements “have led many developers to (use) mid-size and small-tier CMOs who have the scale of equipment suited to meet the demands of a smaller patient population.”

Final thoughts

By no means is this article a comprehensive review of all challenges faced by pharma and biopharma in the year to come. In fact, other concerns raised by the industry included the re-opening of EU pharmaceutical legislation this year and the continued use of virtual site inspections by regulators, which we ran out of space to cover here.

Advanced, automated, data-controlled processes will certainly be part of the industry’s digitally enhanced future”

The challenges facing pharmaceutical and biopharmaceutical manufacturing in 2022 are varied, from formulation and delivery challenges to skilled labour shortages and shortened timelines. One potential solution for these hurdles is the integration of advanced technologies. According to Casados, such technologies enable drugs to be manufactured more efficiently and compliantly, and at a lower cost: “Pharma is accelerating its digital Industry 4.0 transformation in pursuit of better cGMP [current good manufacturing practice] compliance. The pressure to adopt advanced information and data technologies across the enterprise will not abate and the digitalisation trend will have significant impact on operational expenses and cost-of-goods accounting for years to come… Advanced, automated, data-controlled processes will certainly be part of the industry’s digitally enhanced future.”

(Video) How we’ve been a key driver of the biologics manufacturing evolution, bringing BioProcessing 4.0?

References

  1. GlobalData, 2021.COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships. [online]. Available at: https://store.globaldata.com/report/gdps0038mar
  2. CPhI, 2021.Pharma Trends 2022. [online] CPhI, pp.6-7, 16. Available at https://www.cphi-online.com/cphi-pharma-trends-2022-report… [Accessed 10 January 2022].
  3. mRNA therapeutics clinical pipeline by therapy area worldwide 2021 | Statista [Internet]. Statista. 2021 [cited 10 January 2022]. Available from: https://www.statista.com/statistics/…
  4. Ferreira M, Cabral E, Coroadinha A. Progress and Perspectives in the Development of Lentiviral Vector Producer Cells. Biotechnology Journal [Internet]. 2020 [cited 10 January 2022];16(1):2000017. Available from: https://doi.org/10.1002/biot.202000017
  5. FDA’s Center for Drug Evaluation and Research. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 [Internet]. US Food and Drug Administration (FDA); 2022 pp. 11-12. Available from: https://www.fda.gov/drugs/new-drugs-fda-cders…

Related topics

Active Pharmaceutical Ingredient (API), Biologics, Biopharmaceuticals, Bioproduction, Contract Manufacturing, Drug Manufacturing, Drug Supply Chain, Gene therapy, Industry Insight, Informatics, Lab Automation, Manufacturing, Supply Chain, Technology, Therapeutics, Vaccines

Related organisations

Baxter, Convention on Pharmaceutical Ingredients (CPhI), Genezen, Lonza, MedPharm, Samsung Biologics, US Food and Drug Administration (FDA)

Related people

Bill Vincent (Genezen), Frank Kogelberg (Baxter), James Choi (Samsung Biologics), Lynn Allen (MedPharm), Manjit Singh (Pharmaceutical Supply Chain Initiative [PSCI]), Rose Mary Casados (Lonza CHI)

FAQs

Key challenges for bio/pharmaceutical manufacturing 2022? ›

The challenges facing pharmaceutical and biopharmaceutical manufacturing in 2022 are varied, from formulation and delivery challenges to skilled labour shortages and shortened timelines. One potential solution for these hurdles is the integration of advanced technologies.

What are 2 major problems with the pharmaceutical companies? ›

There are two major issues that have potential for positive interactions between the industry and clinical pharmacy. These are drug selection and reimbursement, and clinical research.

What is the future of biopharma? ›

Biopharma companies will continue to develop new ways to treat and cure a wide range of diseases. However, actionable health insights, driven by radically interoperable data and artificial intelligence (AI), can help clinicians and consumers identify illness much earlier than we do today.

What are the key competitive forces in the pharmaceutical industry? ›

The analysis looks at five competitive forces that influence an industry: threat of new entrants, power of suppliers, power of buyers, availability of substitutes, and competitive rivalry in the industry.

What is the biggest problem in pharmacy today? ›

Six key challenges pharmacists face
  1. Too many disparate resources. ...
  2. Increasing specialty medications. ...
  3. A demand for multitasking. ...
  4. Outdated information across databases. ...
  5. The human and financial cost of medical errors. ...
  6. Awareness of specific patient population needs.
Mar 5, 2022

What are other barriers to entry in the pharmaceutical industry? ›

Issues such as high R&D costs, challenging regulatory approval processes, and intellectual property obstacles are making it increasingly difficult for new companies to enter this competitive market.

What is the biggest issue facing Indian pharma manufacturers? ›

Some Challenges for the Indian Pharmaceutical Industry
  • A lack of a stable pricing and policy environment-The challenge created by unexpected and frequent domestic pricing policy changes in India. ...
  • Lack of capabilities in the innovation space-India is rich in its manpower and talent.

Why is project portfolio management particularly challenging in the pharmaceutical industry? ›

Project selection and portfolio management are particularly challenging in the pharmaceutical industry due to the high risk - high stake nature of the drug development process.

What are the future trends impacting the pharmaceutical industry? ›

New technologies and emerging trends like robotics, artificial intelligence and precision medicine are disrupting the pharmaceutical industry. There's a greater emphasis on prevention rather than cure, with the patient at the centre, and a renewed focus on value as the demand for medicines rises and budgets fall.

What is biopharmaceutical manufacturing? ›

Biopharmaceutical manufacturing is generally characterized by the use of advanced technologies, harnessing of new scientific advances, and driven by a highly complex research and development (R&D) enterprise.

How can the pharmaceutical industry be improved? ›

By investing in quality equipment and creating an efficient maintenance program, pharmaceutical businesses can avoid downtime and errors in production, thereby increasing productivity. Pharmaceutical manufacturing processes are complex, and the facilities contain a wide range of equipment and systems.

What major competitive advantage do large pharmaceutical manufacturers have over small biotech firms? ›

Large drug firms are minimizing financial risk by developing contractual relationships wit hand investing in a number of small biotechnology companies. Advantages of large firms: They are able to offer health plans and PBMs, and drugs at a package discount.

What is bargaining power of buyers in pharmaceutical industry? ›

Bargaining power of buyers

In pharma industry, the buyers are scattered and they as such does not wield much power in the pricing of the products. However, government with its policies, plays an important role in regulating pricing through the NPPA (National Pharmaceutical Pricing Authority).

How dynamic is the pharmaceutical industry? ›

Dynamic Industry

The biopharmaceutical industry is a very dynamic sector. While customer demand is a primary influence, the pharmaceutical industry is also faced with numerous unique pressures that other mainstream industries do not contend with.

What are the current issues in hospital pharmacy? ›

Below are 5 real issues facing hospital pharmacies today:
  • Drug shortages. Any pharmacist will tell you drug shortages are the number one nuisance in hospital pharmacy. ...
  • Sterile compounding. Sterile compounding regulations have been changing significantly every few years. ...
  • Workforce issues. ...
  • CMS measures. ...
  • Opioid epidemic.

What are some of the current topics or events nowadays that are related to pharmacy? ›

These include: Financial Risk-Based Models. Health Outcomes-Based Models.
...
For 2022 pharmacy workforce issues will be a major challenge-driven largely by these 5 key factors:
  • Burnout. ...
  • Increased demand. ...
  • Candidate-driven job market. ...
  • Workforce mobility. ...
  • The growing skills and compensation gap for techs.
Dec 20, 2021

Why is there a shortage of pharmacists? ›

The pharmacist shortage comes at a time when COVID infections are up and the supply of nurses and medical technicians is down. According to the American Hospital Association, almost every hospital in the country has a nursing shortage due to burn out from COVID.

Are there high barriers to entry in pharmaceutical industry? ›

The legal aspect of pharmaceutical manufacturing is agreeably one of the most significant barriers to entry in this market for two reasons. Larger pharmaceutical companies have approved patents that enable them to legally stop new companies from entering the market without establishing a new drug.

What are the risks that pharmaceutical companies face in developing and launching a new product in the market? ›

Six major risks facing pharmaceutical manufacturers in 2021
  • Reduced demand for prescription medicine. ...
  • Growing competition from generic pharmaceuticals. ...
  • Pharmaceutical fraud. ...
  • Rising consumer expectations and difficulties managing brand health. ...
  • Data breaches and other cybersecurity threats. ...
  • Supply chain disruptions.
May 13, 2021

What are exit barriers in an industry? ›

Barriers to exit are obstacles or impediments that prevent a company from exiting a market or industry. Typical barriers to exit include highly specialized assets, which may be difficult to sell or relocate, and high exit costs, such as asset write-offs and closure costs.

What is risk management in pharmaceuticals? ›

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle.

What are the opportunities in pharmaceutical industry? ›

The pharmaceutical sector has numerous opportunities for growth and development
  • Pharmaceutical sales representative. They are sales professionals specialised in selling pharmaceutical and medical products. ...
  • Regulatory specialists. ...
  • Clinical data managers. ...
  • Pharmaceutical research scientists. ...
  • Biotechnology consultant.
Dec 29, 2021

How does WTO affect Indian pharmaceutical industry? ›

The Indian patent regime has become fully TRIPS compliant. The amendment of the Act changed the institutional factors that had supported the growth of the Indian pharmaceutical industry. Under the TRIPS agreement, all WTO members have to make patents available for pharmaceutical inventions in their countries.

What are some of the key difficulties in successfully implementing portfolio management practices? ›

Based on over 20 years of implementing Project Portfolio Management Solutions, here are the 10 key challenges and barriers to PPM adoption faced by most organizations.
  1. Internal Politics and Culture. ...
  2. Appropriate Sponsorship. ...
  3. Project Management Maturity. ...
  4. Management Commitment. ...
  5. A Common Approach. ...
  6. Pet Projects. ...
  7. Pace of Adoption.
Dec 11, 2013

What are the problems facing in portfolio analysis? ›

Among the most widespread business problems that may come in the way of successful project portfolio management are poor visibility into project-related data, productivity gaps due to insufficient task automation, collaboration and communication issues, and suboptimal project selection.

What are the keys to successful project portfolio management What are some of the key difficulties in successfully implementing portfolio management practices? ›

To be successful with project portfolio management, you should have common procedures, applications, and training for the effective sharing of relevant information for portfolio analysis, decision making, goal setting, project status, project prioritization/ranking, and consumed and available resource capacity.

What are two to three key trends facing the pharma industry today? ›

Pharmaceutical Industry Trends: Growing Technology and Innovation
  • Emerging Markets Will Drive Innovation. ...
  • Increased Conflict Between Affordability and Access. ...
  • Mergers and Acquisitions Will Continue to Increase. ...
  • More Tech Innovations/Investment in Manufacturing Processes. ...
  • Increased Prescription Drug Costs.
Aug 17, 2021

What are the new technologies in pharmaceutical industry? ›

What are the Leading Pharma Healthtech Trends?
  • Artificial Intelligence.
  • Wearable Tech Integration.
  • Data Management & Analytics.
  • Single-Use Processes.
  • Precision Medicine.
  • Bioprinting.
  • “In Silico” Testing.
  • Real-World Data.
May 31, 2022

What is 3D printing in pharmaceutical industry? ›

The introduction of 3D printing into the pharmaceutical technology particularly aims at the development of patient-centered dosage forms based on structure design. It is still a new research direction with potential to create the targeted release drug delivery systems in freeform geometries.

What is the biggest issue facing Indian pharma manufacturers? ›

Some Challenges for the Indian Pharmaceutical Industry
  • A lack of a stable pricing and policy environment-The challenge created by unexpected and frequent domestic pricing policy changes in India. ...
  • Lack of capabilities in the innovation space-India is rich in its manpower and talent.

What is risk assessment in pharmaceutical industry? ›

The Risk Assessment consists in the identification of hazards, analysis and evaluation of risks associated with exposure to those hazards Risk assessment defines with three fundamental questions. a) Risk Identification address what might go wrong. b) Risk analysis, to analyze the risk involved.

What are the opportunities in pharmaceutical industry? ›

The pharmaceutical sector has numerous opportunities for growth and development
  • Pharmaceutical sales representative. They are sales professionals specialised in selling pharmaceutical and medical products. ...
  • Regulatory specialists. ...
  • Clinical data managers. ...
  • Pharmaceutical research scientists. ...
  • Biotechnology consultant.
Dec 29, 2021

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