Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

Despite the continued turbulence from COVID-19, the bio/pharma industry experienced another good year for drug approvals in 2021. The latest available figures from the European Medicines Agency (EMA) showed that 2021 marketing authorizations were granted to 82 therapies, 14 of which were for generic medicines and seven of which were for biosimilars (1).

However, a drug that has been hitting headlines and was highlighted as ‘one to watch’ by Clarivate in 2021 (2), aducanumab from Biogen and Eisai, has not gained a favourable decision from EMA (3). Main reasons for the refusal of the marketing authorization of the drug included the fact that the effect of amyloid beta reduction in the brain and clinical improvement from Alzheimer’s has not been established, conflicting study results, and insufficient proof of safety (3). The three remaining drugs from the four highlighted in Clarivate’s 2021 report (2), bimekizumab, relugolix, and vericiguat, all gained marketing authorization in the European Union.

For 2022, Clarivate has highlighted seven late-stage treatments that its analysts expect to reach blockbuster status (i.e., earn US$1 billion [€873 million] or more in annual revenue) in the next five years. The therapies that have been picked out are adagrasib from Mirati Therapeutics and Zai Lab, faricimab from Roche and Chugai Pharmaceutical, lecanemab from Eisai and Biogen, donanemab from Eli Lilly and Company, tezepelumab from Amgen and AstraZeneca, tirzepatide from Eli Lilly and Company, and vutrisiran from Alnylam Pharmaceuticals (4).

The therapeutic targets for these treatments range from Alzheimer’s disease to cancer and eye disease to asthma, and the majority of the drugs fall under the classification of biologics. Projected sales for all of the drugs highlighted are reasonably similar with the exception of tirzepatide, which the analysts predicted could make US$4.55 billion (€3.97 billion) in sales by 2026 (4).

Only time will tell as to whether or not these promising medicines will indeed be the next ‘blockbusters’.

, Report (March 2021).
3. EMA, “Refusal of the Marketing Authorization for Aduhelm (Aducanumab),” Regulatory Document, 17 Dec. 2021.
4. Clarivate, 

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Hot Picks for 2022,” 

Articles

Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?

Hot Picks for 2022

As most APIs have an unpleasant or bitter taste, solutions to help mask the flavor are integral in ensuring a dosage form’s palatability and commercial success. To learn more about the potential solutions currently available to formulators for taste-masking, as well as those approaches in the pipeline, best practices, and excipient considerations, Pharmaceutical Technology spoke with Kevin Hughes, manager Regulatory Affairs at Colorcon; David Tisi, technical director at Senopsys; and Bing Xun Tan, PhD, Pharmaceutical Application Laboratory manager at Roquette’s Asia Pacific Innovation Center in Singapore.

 How important is taste-masking and what formulation approaches are currently available?

 Many APIs inherently possess a bitter taste. If a medication is not palatable, the patient may opt to discontinue taking their dose. Failure to take medication as prescribed can lead to avoidable healthcare costs, and potentially increased morbidity and mortality. While objectionable taste may be one of several reasons for poor adherence, every measure that minimizes these reasons helps.

The most popular oral dosage forms include liquids, powders, granules, and tablets—especially orally disintegrating tablets (ODT) and chewable tablets. Each one has pros and cons, depending on the target age group. Liquids, powders, and granules provide the greatest flexibility in dosing, provided there is a simple way to meter the powders. The commonly used techniques/methods of taste-masking include organoleptic methods, polymer coating, hot-melt extrusion, microencapsulation, complexation using ion-exchange resins, and spray-drying.

A more recent application is the use of ion-exchange resins, the resin-drug complexes formed will elute only a limited percentage of the drug in the saliva pH. Thus, the taste of the drug is masked without interrupting the drug release profile.

 Simply put, patients will not routinely take medicines that are unpleasant to them. A patient may take their first dose or even tolerate a bad tasting acute therapy, but for chronic indications, poor palatability has a negative effect on adherence/compliance.

Aside from the ethics of improving patient quality of life and the business case made for improved adherence, there are regulatory obligations and rewards for improving palatability in special populations. Both FDA and the European Medicines Agency (EMA) require palatability to be considered in a sponsor’s Pediatric Study and Investigation Plans, respectively (1,2), in the submission package for the adult form. Such studies should include an assessment of formulation palatability.

Properly addressing the palatability challenge of a specific formulation will depend on the target form, type of API, chemical properties, and taste-masking challenge (how unpalatable the API is).

 Taste-masking solutions can enable the development of innovative orodispersible dosage forms, which are considered more patient-friendly. In the nutraceuticals market, where consumers can choose from a multitude of commercial offerings, product taste can be a deciding factor when it comes to making their purchasing decision.

Taste masking of pharmaceutical drug products is generally achieved through one, or a combination, of the following three approaches. The first approach involves chemical modification of the API to reduce bitterness.

The second approach uses excipients in formulation to facilitate a direct sweetening effect and/or reduction of the perceived API bitterness. Careful selection of excipients can enable formulation strategies using flavors, sweeteners, and bitter blockers. Pleasant-tasting, highly viscous, or lipophilic vehicles can also provide an effective taste-masking effect.

Lastly, advanced processing of the API or drug product can help minimize oral solubility and direct contact with the taste buds. Common approaches include coating of API particles with a physical barrier; tablet film coating or sugar coating; microencapsulation; embedment of API particles in a matrix; microspheres and liposomes; complexation of API with cyclodextrins or ion-exchange resins; and adsorption of the API using insoluble powders.

 Are there best formulation practices to follow for taste-masking?

 In formulation, the difficulty of taste-masking is increased when the API possesses a strong bitter taste, high solubility in the buccal cavity, or when a high dose of the API is required.

It’s best practice to consider taste masking early in the product development process, as major regulatory agencies now require new drug product developments to include pediatric trials. [As a result of regulatory requirements] pharmaceutical companies are focusing on taste-masking solutions and palatability studies that can aid development and demonstrate patient compliance of the drug product for children. Early consideration of the potential need and solution for taste masking can help minimize potential delays later in the process.

 Several factors go into the decision process for the formulation, including properties of the API, dose level, dosage form, desired release profile, and so on. Both dissolution profile and taste profile contribute to the acceptability criteria for taste-masked formulations. However, each drug product will have different release profile requirements to meet an acceptable level of taste-masking depending on the dose strength and organoleptic response to the API. Ideally, the taste-masked dosage form should prevent the release of an unacceptable tasting medicine until the API has left the mouth, then allow for immediate release once the dosage has been ingested.

There are two main categories of coatings for taste-masking: pH-independent and pH-dependent. For most solid oral dosage forms or tablets, the active (API) is blended with several excipients, and a well-designed film coating, either pH-dependent or pH-independent, to adequately mask objectionable tastes for the brief residence time in the mouth before swallowing. Alternative dosages forms, such as chewables and granules, can increase the contact time in the mouth, giving an unpleas­ant experience and/or lingering aftertaste. In these cases, it is often necessary to create a barrier, such as a specific taste-mask coating, between the API and the taste buds to improve palatability and aid compliance.

 Formulators need to establish a target product profile (TPP) as soon as possible, as it guides all downstream development. The TPP outlines important questions including identifying the drug form, clinical strength, and dose volume. If these are initially unknown, an understanding of a drug’s sensory properties early on will focus development on those formulations most suitable to the challenges of the molecule.

Many (though not all) drugs have bitter or other aversive sensory characteristics, which may include a negative taste, smell, or irritation. These characteristics represent different perception pathways and importantly, the approach for dealing with each is fundamentally different. For instance, an API with only slight or moderate aversive sensory characteristics has many more formulation options than does a very intense or lingering API, which will require physical encapsulation as part of the formulation.

 Is the use of alternative dosage forms creating new challenges for taste-masking?

 Special populations such as pediatrics or geriatrics can have difficulty swallowing adult oral solid forms (dysphagia). Without exception, easier-to-swallow dosage forms increase the opportunity for contact with relevant sensory receptors of the patient. Accordingly, alternative formulations have an increased palatability challenge compared to traditional tablets and capsules. Some API sequestration taste-masking approaches (e.g., particle coating) result in an increase in particle size that often results in a gritty texture. Grittiness may reduce palatability in infants who have not been introduced to particulate foods. In addition, the presence of particulates can encourage chewing as part of normal oral processing. This can rupture coatings, releasing API in the oral cavity where it will be perceived. Additionally, some multiparticulate formulations are intended for dosing in foods, and the physiochemical properties of the foods may affect palatability, particularly if they are coated with a pH sensitive polymer.

 The pharmaceutical industry is actively looking into more patient-centric and age-appropriate dosage forms. Alternative dosage forms such as ODTs or orally disintegrating films (ODFs) are examples of these developments, to name a few.

Such products are designed to rapidly disintegrate in the mouth, where bitter APIs can have a prolonged direct exposure to taste buds, which results in poor palatability. However, excipients such as hydroxypropyl-β-cyclodextrin and pea-based maltodextrin have been successfully used to mask ODFs containing dimenhydrinate, an antihistamine used to treat motion sickness and nausea, and loratadine, also an antihistamine used to treatallergies (3,4).

 Alternative dosage forms such as sachets, ODTs, and chewable dosage forms pose additional challenges in taste-masking due to increased contact surface area as well as residence time in the mouth, enhancing any unpleasant taste and/or lingering aftertaste. In these cases, it is often necessary to create a barrier, such as a specific taste-mask coating, between the API and the taste buds to improve palatability and aid compliance.

 What impact might the new excipient pilot program, launched by the FDA’s Center for Drug Evaluation and Research (CDER), have on taste-masking?

 The new CDER pilot program for novel excipients is a welcome initiative from FDA, it offers a new pathway for drug manufacturers to get an FDA review of novel excipients before the excipients are used in a formulation. Before this, the selection of a novel excipient by a drug manufacturer carried a higher risk, the New Drug Application could get held up by questions being asked about the safety and quality of a new excipient for example. With this initiative, the drug manufacturer can do this up-front, and this will reduce the risk to their timeline and make it much easier to select a novel excipient for dosage forms. Taste masking is one of the areas where different approaches and new materials are being explored all the time, and new materials that have no history of use in pharmaceuticals or foods can be assessed more quickly under this program.

 Senopsys is a strong supporter of CDERs’ pilot program to expedite the use of novel excipients. Co-processed flavor and sweetener system technologies similar to those used in the confectionery and chewing gum industry can sustain release of the flavor system over time. Such development has been hindered by the current lengthy excipient approval path.

 There are limited excipient options today that may be used to taste-mask APIs, and even fewer for formulations meant for pediatric patients. New pharmaceutical processing techniques used in taste-masked formulations, such as 3D-printing, also require suitable excipients better designed to facilitate these modern processes (5). The new pilot program, launched by CDER, could enable the introduction of novel excipients, which may have a precedence of use and/or research in other industries—such as food—where there is already existing emphasis and expertise in terms of taste.

 Are there any approaches in the pipeline that you believe will hold great promise for taste-masking in the future?

Tan (Roquette): A pea maltodextrin product from Roquette (KLEPTOSE Linecaps) has been primarily designed for taste-masking and solubility enhancement applications, with a particular suitability for pediatric formulations.

The pea maltodextrin can decrease exposure of the API to the taste buds through a specific mechanism of action and complements the current range of taste-masking excipients available to formulators. This excipient has been shown to exhibit a taste-masking effect on model APIs, such as loperamide hydrochloride and dextromethorphan hydrobromide (6).

 The traditional way to taste mask a bitter-tasting active material is to put a barrier between the active material and the sensory receptors for taste or to hide the bitterness of the material by including a flavor or sweetener in the formulation. It is common for both methods to be used at the same time.

New ways of placing that physical barrier around the bitter API are being evaluated, such as ion-exchange resins that can be used to create an API-resin complex that blocks the taste of the API but does not impact its bioavailability; hot melt coatings can be applied to the API or tablet to become a barrier that does not dissolve in the mouth and pH-sensitive polymers that are insoluble in the mouth but dissolve in the stomach pH can also perform this function.

Another interesting approach is to block the taste receptors, Danielle Andrews from University College London in the United Kingdom had a poster at the European Paediatrics Formulation Initiative Conference in September 2021 where she showed that sodium salts could be used as a ‘bitter blocker’ to effectively switch off the taste receptor temporarily (7). There is plenty of activity in this area, especially around pediatric medicine development.

 One of the more interesting technologies that has not yet been fully employed in formulation development is the use of novel flavoring materials that disrupt taste signal perception. In humans, bitter taste is detected by a family of several dozen bitterness receptors (TAS2Rs). APIs are typically promiscuous in their receptor targets, activating multiple TAS2Rs simultaneously. Novel compounds are under development which act as antagonists to these receptors.

While promising, there are a number of hurdles to this approach. By their very nature, molecules that disrupt the taste signal cascade are bioactive compounds, and most drug developers are reluctant to risk their drug on possible interaction with an excipient. Next, signal disrupting excipients are proprietary compounds that have to be matched to the specific set of receptors that act upon their API, so this approach is not a one-size-fits-all-compounds magic bullet. Finally, the published data on this class of materials shows some bitter attenuation, but not complete masking. Accordingly, if used it would be one of a multi-pronged approach to palatability.

, Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans

, Industry Guidance, July 2020.
2. EMA, “Paediatric Investigation Plans,” 

 [accessed Nov. 10, 2021].
3. M. Preis, M. Pein, and J. Breitkreutz, 

, 4 (4) 551–562 (2012).
4. W.C. Foo, et al., “A Multifunctional Orodispersible Film System with Hydroxypropyl-β-Cyclodextrin,” poster presentation at 

 (virtual conference), October 2020.
5. Z. Wang, et al., 

, 38 (5) 831–842 (2021).
6. M. Preis, et al., 

., 193, 442–450 (2014).
7. D. Andrews, et al., “Applicability of Sodium Salts as Bitter-Blocking Excipients: A BATA Case Study with 2 Bitter Paediatric Drugs,” poster presentation at 


Vol. 45, No. 12
December 2021
Pages: 26–28

When referring to this article, please cite it as F. Thomas, “It’s a Matter of Taste-Masking,” 

Increased patient-centricity and alternative dosage forms require careful consideration when selecting the best taste-masking approach.

It’s a Matter of Taste-Masking

Whether characterizing particle size or structure, or investigating any possible contamination, particle analysis plays a critical part in bio/pharmaceutical development and manufacture. “Particle analysis is a critical tool to define, help manage, and deliver product quality,” confirms Michael Lindsay, SGS Global scientific director.

“Desired product performance greatly influences how the API needs to perform with regards to solubility, rate of solubility, and permeability to access the target site or be available for systemic circulation,” Lindsay continues. “Typically, the API is blended with other non-active ingredients, each with their own contributing property attributes, to help deliver the API in the desired media to a patient as a solid, semi solid, liquid or gas/powder.”

Essentially, achieving a sufficiently homogenous mixture and product is a key manufacturing goal, but there are multiple characteristics that can impact this, such as physical aspects (size, shape, density), particle charge, smoothness, and the ability to blend and flow, Lindsay notes. “These features can be critical quality attributes in process steps from: initial synthesis through crystallization, if needed; processing and blending in production into the final package to contribute final product performance,” he says. “Collectively, these factors influence which particle analysis methods are used to evaluate material behavior to determine criticality; and, with defined specifications become necessary to ensure consistent product quality and performance.”

During manufacture, drug products come into contact with other surfaces and can be exposed to the air, which could lead to potential contamination from particulates, Lindsay asserts. “Therefore, particle analysis also serves as an investigative tool to ensure there are no unacceptable contaminants,” he says. “Where contaminants are present, particle analysis helps identify root causes for such contaminants, so that actions are taken to eliminate them to further ensure product safety.”

There are numerous techniques that are currently available for particle analysis, which can be categorized around both chemical and physical properties, Lindsay explains. Additionally, it is possible to use single or multiple methods to reveal the expected materials performance so that an acceptable product can be yielded, he adds.

 “Material solubility is a significant contributor to product performance where particle size reduction corelates with increased surface area to influence rate of dissolution. Thus, multiple methods are used to measure particle size,” Lindsay says. “A desirable decrease in particle size can facilitate higher dissolution with increased surface area and can also increase the rate of degradation and impact product stability too. Therefore, particle size analysis is one of the most important techniques.”

A relatively easy method that requires minimal expertise and no sample preparation is sieving, which includes air jet sieving, specifies Lindsay. However, with this method between 10 g and 100 g of material is consumed, there is a lower particle size limit (>20–50 µm), the range of sieves reduces data points, and it is only possible to be used with dry materials, he states.

Through the use of light microscopy with high resolution-image analysis, it is possible to fully visualize and inspect particles, Lindsay confirms. This method provides such advantages as a 1–1000 µm dynamic range, visualization of solubility (if it occurs), capability of confirming aggregation and particle fragmentation, and the ability of confirming crystallinity, degree of crystallization, crystal quality, and shape. Considerations to take into account when using this approach are solvent evaporation; multiple fields of view; and non-random particle orientation if particle size or shape is also being measured.

Laser diffraction only requires a small amount of sample (>10 mg to a few grams), can be used with wet or dry particles, and offers a dynamic size range of 0.01–2500 µm (dependent on instrument, technique, and configuration of instrument), Lindsay continues. For wet analysis, however, the solubility of the material should be considered, he adds. Additionally, expertise for method development is required, and the particle shape needs to be contemplated when the technique assumes a sphere.

A small quantity of sample (±1 mg or less as a minimum) is also required when using dynamic light scattering (DLS) as a technique for particle size analysis. The dynamic range offered is between 0.3 nm–10 µm and the estimated average molecular weight range catered for is 1 x 103 to 1 x 107 Daltons (both dependent on instrument, technique, and configuration of instrument), Lindsay states. Similar considerations are required for DLS as with laser diffraction: solubility, expertise, and particle shape.

Dynamic image analysis or Micro-Flow Imaging (ProteinSimple, Calif., USA) is another particle size technique that only requires a small quantity of sample (<1 mL). This approach offers a dynamic range of 1–300 µm (dependent on instrument, technique, and configuration of instrument), provides the ability to see particles, allows visualization and measurement of particle shape and morphology, tests most of the sample, can be used with high viscosity samples (up to 20 centipoise), and can enable visualization of contaminant particles, Lindsay asserts. Solubility and expertise are considerations to take into account with this method, along with the need to view sufficient images for confirmation of particle distribution because particles are visualized in a random orientation.

“A consideration for all methods discussed is that the sample tested must be representative of the bulk; particle size is measured through a variety of techniques, where in development orthogonal approaches may be taken to evaluate which provides the more meaningful data to control quality,” Lindsay stresses.

 “Other techniques can be employed to visualize particles, isolated or not, to better describe the particle and aid in identification of potential contaminants,” states Lindsay.

When evaluating surface area of particles, it is possible to use the Nitrogen Brunauer-Emmett-Teller (BET) method. “Surface area most influences solubility of a material in solution and can be additionally measured as an orthogonal technique to particle size,” Lindsay says. “As particle size decreases surface area increases per unit mass and reported as m2/g to positively increase potential dissolution rate. Thus, particle size/surface area is used to help control dissolution rate in some products.”

Measuring the surface area of particles becomes particularly important for chemically unstable compounds, Lindsay explains. For these compounds, if there is an increased surface area there will be an increased degradation rate, which influences the formulation protection or coating that has been implemented to prevent degradation.

Surface charge method can be used to evaluate the Zeta potential—the charge on a particle at the shear plane. This property is important for the understanding and prediction of how particles will interact in and successfully stay in suspensions with other particles, Lindsay confirms.

Flowability of particles, which is critical for powder blends, can be measured with a variety of methods, such as funnel, angle of repose, powder viscometry/rheology, and so on. “The ability to flow evenly is a requisite for gravity assisted processes, where flow is uneven or there are vibrations differences in flow, density, particle size can lead to size or material separation to de-mix a once uniform blend,” Lindsay says.

Pycnometry/a densitometer can be used to measure the material density at a material level and to measure that property at a bulk scale, it is possible to use tap and bulk density testing. The latter method can also provide details that will allow for an understanding of how particles will settle together, Lindsay notes.

 All products to be administered via injection need to undergo a visual inspection to check for particulates as per regulatory guidance, such as the United States Pharmacopeia Chapter <790> and European Pharmacopoeia Chapter 2.9.20 (1,2). The visual checks involve an inspection of the sample against a black and against a white background, with the naked eye and without magnification, under standardized light conditions, Lindsay states.

Light microscopy can be used to visualize the particles and their surface properties to a size of 1 µm. Additionally, this technique allows for particle geometry to be evaluated and measured, and can provide confirmation of crystal properties, Lindsay reveals. A simple count of particles in liquid samples, at set sizes between 10 µm and 25 µm, can be done using light obscuration, he adds.

Microscopy coupled with Fourier-transform infrared or Raman spectroscopy may be used to identify particles greater than 10–20 µm, although particles must be cleaned of other materials to improve spectral quality, Lindsay stresses. Scanning electron microscopy and energy dispersive X-ray analysis are useful for the visualization of the material and for elemental identification, particularly for metal/alloy contaminants.

“Particle analysis techniques have advanced greatly from the simple sieve to the use of laser and high-speed image and spectroscopic systems to gather more meaningful sample data on the particle to better describe the particle shape, size, density, and identity faster,” says Lindsay. “Also, providing the sample is representative, results are obtained with much less material thus enabling accurate measurements on very expensive materials at lower cost.”

Thanks to advancements in optical and spectroscopic techniques, it is now possible to capture images of the particle flow in real-time, allowing for particle identification, Lindsay reveals. Additionally, smaller particles (>0.3 nm) can be optically detected and measured using light scattering techniques, he adds.

“Data processors, detectors, and processing speed have contributed significantly to the advancement of new instrumentation that are both smaller and faster than previous instruments,” Lindsay says. “Bench instrument components are now being built into flowing or blending processes to also enable real-time in-situ non-destructive analysis and include final in vial measurements so that no additional material is consumed. Spectroscopic techniques, with complex libraries and processing for spectral analysis, enable real-time monitoring of blends to confirm material concentration and uniformity.”

In the future, continued advancement in analytical measurement abilities for all aspects of particle analysis to the limits of what physics will allow is expected, Lindsay emphasizes. Further miniaturization of instruments to enable measurements of lower volumes and greater speed in flowing systems and an increased use of process analytical technology (PAT) solutions that separate offline analysis will transpire, he states.

“In time industry should expect to see more analytical instrument techniques be part of the PAT solution to reduce some laboratory testing outside of the particle analysis areas too,” Lindsay adds. “The regulations already support alternate techniques to better manage risk and assure quality. Data analytics with smarter artificial intelligence will help identify and correct processes, within defined and approved design and quality-by-design spaces, seamlessly to enable more effective production.”

 <790>, “Visible Particulates in Injections,” 

 Chapter 2.9.20, “Particulate Contamination: Visible Particles” (Strasbourg, France, 2008).


Vol. 45, No. 12
December 2021
Pages: 44–45,48

When referring to this article, please cite it as F. Thomas, “Not a Particle of Doubt,” 

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

Not a Particle of Doubt

University spinouts enable the commercialization of innovative research from academic institutions, providing early-stage project visibility for Big Pharma companies and investors, creation of intellectual property, and technology transfer services. The benefits of university spinouts, such as BioNTech for example, have been irrefutably proven over the course of the COVID-19 pandemic.

Intellectual property services and R&D tax credit specialists, GovGrant, performed analysis of data for companies founded in the past 20 years. Their analysis revealed that, in the United Kingdom, university spinouts in the fields of pharmaceuticals and biotechnology managed to raise the most capital (1). In fact, half of all the capital raised, which is worth £5.9 billion, went to pharmaceutical and biotech spinout companies.

Additionally, based on its analysis, GovGrant found that seven of the top 10 most successful university spinouts from the past decade are housed within the pharmaceutical and biotechnology industries. The top‑ranking spinout, Exscientia from the University of Dundee, is valued at £784.5 million (1).

However, despite the publicised success stories, there are still hurdles for European university spinouts to overcome. A potentially success-limiting issue for university spinouts is the continuing lack of sufficient late-stage funding (2). Even with growth in late-stage funds since 2010 and higher returns on investment in Europe, the region still lags behind the United States and China in the biotech sector (3). Then there is the challenge with equity shares and revenue royalties that have been specified as ‘too high’ in Europe, which is not necessarily the case for US academic entrepreneurs (4).

So, how might Europe as a whole begin to take advantage of the innovation borne from academic institutions in the longer term? Domestic funding, particularly during the late stages would be a good start (5).

, Research Report (November 2021).
2. C. Lang, “Biotech Investments in Germany ‘Could Prove to be a Treasure Trove’,” 

, Analysis Article, 5 May 2021.
3. McKinsey & Company, “Infographic: Capital Landscape for European Biotechs is Maturing, but it Continues to Trail the United States,” Article, 12 Aug. 2021.
4. N. Benaich, “Universities in the UK and Europe Have a Start-Up Problem,” 

, Article, 10 May 2021.
5. M. Palmer, “Should the New UK £375m ‘Breakthrough’ Fund Back Startups or Scaleups?” 

When referring to this article, please cite it as F. Thomas, “Spinning Success?” 

Pharma and biotech are ruling the roost in terms of university innovation, but European spinouts are still experiencing barriers to long-term success.

Spinning Success? The Benefits of University Spinouts

For aseptically produced products, contamination control is critical. As a result, various associations and regulatory bodies have published guidance documents on the many safeguards required to ensure compliance with requirements. Most recently, industry has been awaiting the revised Annex 1 guidance from the European Union, which is currently still under consideration in draft form. Additionally, there is an increasing proportion of products in development that cannot be terminally sterilized, meaning there is a rising need for efficient aseptic processing solutions. In a keynote session titled “Evolution of Aseptic Processing”, presented at INTERPHEX 2021 on Oct. 20, 2021, several experts discussed the evolution of aseptic processing and provided insights into some of the challenges and opportunities facing the bio/pharma industry today.

The session was moderated by Felicity Thomas, European editor, 

Pharmaceutical Technology, Pharmaceutical Technology Europe, 

. In this video, Felicity interviewed Jordi Serrat, Product & Technology Director, Azbil Telstar. Jordi spoke about the role of disruptive and digital technologies in aseptic processing.

This video is part 5 of 5. The other speakers in this session were:

Part 1: Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex.

Part 2: Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG.

Part 3: Luke Stockhausen, Lead Process Engineer, CRB.

Part 4: Rafael Beaus, Global Consultancy Manager, Azbil Telstar.

Watch other videos in this keynote series:

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 5

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, 

serialization from a regulatory perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 3: serialization from a software perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

 leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

Watch other videos in this keynote series

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.