5 Cutting-Edge Ways Technology Is Reinventing the Biopharma Industry

 

The biopharma industry is no stranger to technological innovation. It’s at the very core of the sector, so it’s no surprise that pharmaceuticals are undergoing significant change in today’s rapidly advancing, tech-driven environment. New biopharmaceutical technology is revolutionizing patient care, medical accessibility and more.

 

By Emily Newton

 

Pharma manufacturers must stay abreast of these changes to remain competitive and better serve public health. With that in mind, here are five ways technology is reshaping the biopharmaceutical industry.

1. AI Drug Discovery

Artificial intelligence (AI) is disrupting many industries today, and the pharma sector is no exception. Automated drug discovery is one of its most promising use cases for biopharma companies.

 

AI can simulate interactions between different chemicals or genetic materials to highlight potential drug candidates. Moderna used this technology to simulate 1,000 mRNA sequences per month when manual alternatives would’ve only produced 30. This rapid testing is part of what led to the remarkable release timelines of COVID-19 vaccines.

 

In addition to being fast, AI is often more accurate than humans at spotting trends in data. Consequently, AI-assisted drug discovery may lead to more effective medicines. This combination of efficacy and short R&D periods has massive marketability potential for pharma producers.

2. Gene Editing Possibilities

New biopharmaceutical technology also opens new opportunities in gene editing. While techniques like CRISPR have been around for decades, they’ve only recently received approval for use in human patients. Genome editing technology can also help craft more effective pharmaceutical products.

 

Genetic engineering lets pharma companies hone in on natural materials’ pharmaceutical benefits to synthesize new, more targeted and effective remedies. This process typically involves long, complex R&D, but AI can accelerate it by simulating possible solutions and outcomes.

 

Gene editing becomes increasingly valuable as active pharmaceutical ingredients (APIs) become increasingly difficult and costly to source. Genetic engineering could help derive treatments from more widely available resources to lower drug production costs and enable faster expansion.

3. Streamlined Biopharma Manufacturing

Cutting-edge technology has promising applications on the manufacturing side of the biopharma industry. Recent innovations focus on enabling faster production timelines without sacrificing quality or safety. In addition to lowering manufacturing costs, these improvements make drugs more accessible to the public.

 

Pharma manufacturers can use acoustic resonance mixing to combine materials in a few minutes when conventional methods would take hours. Newer perfusion techniques and equipment overcome reliability issues to enable continuous bioprocessing. Using this technology instead of batch processing can dramatically lower lead times and related costs.

 

More generalized manufacturing technology can also help. Digital twins provide virtual recreations of production lines. AI can then analyze them to highlight inefficiencies and suggest workflow changes for continuous improvement. Internet of Things (IoT) sensors can provide timely warnings of equipment failures and other disruptions to minimize downtime.

4. Personalized Medicine

As in many other industries, new tech is pushing biopharmaceuticals toward personalization. Medical organizations can now tailor treatments to the individual for better health outcomes with fewer side effects.

 

Personalized pharmaceuticals are only possible with rapid manufacturing processes. Biological 3D printing, AI discovery and extensive automation make this efficiency possible. Modular manufacturing equipment and collaborative robots (cobots) help further by improving flexibility and enabling quick changeovers to meet different needs.

 

This level of personalization also relies on machine learning. Predictive AI models make it possible by analyzing patients’ medical history to predict how they’ll respond to different treatments. Medical professionals can then find the best course of action faster.

5. Sustainable Biopharmaceuticals

Biopharmaceutical technology can also help the sector become more sustainable. The pharmaceutical industry’s high energy consumption and reliance on difficult-to-obtain materials for APIs significantly contribute to climate change. Thankfully, technology provides a solution.

 

Renewable energy sources like wind and solar can lead to a 45% reduction in carbon emissions in drug manufacturing workflows. As this technology improves, renewables will become increasingly reliable and commercially viable. Similarly, large-scale electric vehicles are becoming increasingly common, helping pharma companies reduce their supply chain emissions.

 

Pharma-specific technologies can also help. AI drug discovery can help craft climate-friendly treatments by looking for alternatives with more naturally abundant APIs. Newer synthetic chemistry equipment can synthesize APIs with less waste, further reducing the sector’s energy and resource consumption.

Biopharmaceutical Technology Is Reshaping the Sector

In most industries, technological innovation boosts efficiency and reduces costs. In the biopharmaceutical sector, it can save lives. Pharma companies can also reap the same monetary benefits from tech adoption, but their unique role makes innovation imperative. Embracing advancements isn’t just good for business but essential for people’s health.

 

These five use cases for biopharmaceutical technology are just a sample of how new tech can reshape the industry. As more organizations embrace this change, the sector will become faster and more sustainable, flexible and effective at treating unique needs. These improvements will have significant ripple effects worldwide. It all starts with learning what new technology can do.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Approaching bioburden testing: Pointers for a successful approach

 

Bioburden refers to the microbial content of a material (or on the surface). It can also refer to the microbial levels within the environment. For non-sterile products, understanding the level and types of microorganisms together with the route of administration and intended patient population is of great importance. For sterile pharmaceutical products knowing the bioburden during manufacturing, from the cleanroom environment, and immediately prior to sterilisation are of importance in order to have confidence that the sterilisation step will be effective or that aseptic filling begins with an unadulterated bulk. This article considers the scientific basis to bioburden testing.

By Tim Sandle

In relation to assessing the level of microbial content during processing, bioburden testing refers to an estimation of the numbers of bacteria and fungi present in a liquid sample. This is commonly assessed using the Total Viable Count (TVC) method, whereby a portion of the material is plated out onto agar or mixed with agar and the incubated to assess microbial growth. 

 

To assess growth the common TVC methods are membrane filtration (where a portion of material or a rinse of the material is passed through a microbially retentive membrane filter); pour plate; and spread plate. Due to the larger size of material that can be tested and due to the relative ease of eliminating any antimicrobial activity, membrane filtration is the method of choice and the other methods are deployed only where a material cannot be filtered. With the advent of rapid microbiological methods, alternatives are available to some of these traditional growth-based methods.

 

With the conventional methods, the method of reporting a result from a test is by colony forming units (CFU) per unit of testing (typically CFU per mL or per 100 mL). A colony forming unit does not necessarily equate with a number of microorganisms present in the sample but it does provide an indicator of the bioburden load. This is because a colony forming unit (CFU) is an estimate of one or more microbial cells which, on the introduction of microbial growth media, can form macro-colonies under the conditions of the test. One colony forming unit is expressed as 1 CFU.

 

In relation to pharmaceutical processing, bioburden testing is implemented in order to assess the quality of the starting materials and to track process hygiene as the product is being manufactured. With non-sterile products a bioburden assessment is additionally required of the final product. Here it is expected that such products will contain a level of bioburden, therefore what matters is how many microorganisms are present and which species are present. With sterile products an assessment is required up until the point where a product is sterilised (either terminally sterilised or filtered and then aseptically filled).

 

In drawing up a bioburden test regime a number of factors need to be considered. These include:

 

• The time of sampling (in order to assess process hold times, sampling normally occurs at the end of the process in order to assess any growth of microorganisms).
• Sample homogeneity (where possible, samples are taken from a homogenous bulk. This means, that where there is a process mixing step, samples are taken post-mixing).
• Sampling handling and aseptic technique.
• The use of sterile sampling containers.
• Selection of test methods and verification of method suitability (this includes the appropriate test agar and incubation times).
• The expiry time of the sample (what is the last point in time when the sample can be tested and a ‘valid’ result be obtained?)
• Assignment of alert and action levels.

 

In relation to the environment, this is assessed through microbiological monitoring using active air-samplers, settle plates and contact plates, supported by particle counting.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Manipulation of gut microbiota with flaxseed could reduce breast cancer risk

 

A study demonstrates that the human gut microbiome may be a factor in breast health. In the study, flaxseed components called lignans were shown to influence the relationship between gut microorganisms and the expression of mammary gland microRNAs (miRNAs).

miRNAs are short, noncoding RNAs that regulate gene expression by targeting the 3' untranslated region of target mRNAs. A subset of these miRNAs regulates the genes involved in breast cancer, including genes that control cell proliferation and migration. 

Monitoring science

The gastrointestinal microbiota appears to play an important role in modifying many components of our diet to impact human health. The researchers studied the effects of flaxseed lignans on the microbiota of young female mice.

One flaxseed oil lignan requires microbial processing to release bioactive metabolites, small-molecule chemicals produced during metabolism that influence physiology and disease -- in this case, having antitumor effects.

Hence, the investigators found correlations between diets enriched in flaxseed, caecal microbiota composition, and miRNA profiles in the mammary gland that regulate many pathways, including those involved in cancer development.

Lignans, fibre-associated compounds found in many foods and particularly plentiful in flaxseed, are associated with reduced breast cancer mortality in postmenopausal women.

The researchers found that lignan components generate specific miRNA responses in the mammary gland.

The preliminary results support further research into the role that the microbiota plays in dietary approaches to reduce risk factors associated with disease.

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Reference:

Diana Wu, Lilian U. Thompson, Elena M. Comelli. Cecal microbiota and mammary gland microRNA signatures are related and modifiable by dietary flaxseed with implications for breast cancer risk. Microbiology Spectrum, 2023; DOI: 10.1128/spectrum.02290-23

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)