Pharma Prospects

(Plants and projects with flow and treat insights)

January 4, 2022



·         Containment Isolators & Glove Boxes

·         CraneCPE has intelligent solutions for diaphragm valves

·         Validating safety of materials in single use filters

·         Minimizing pump pulsation negative impacts




·         Novo Nordisk plans $2.6bn pharma build with engineering partner NNE

·         Britons expect continued collaboration in (bio)pharmaceutical research

·         EMA launches the Regulatory Science Research Needs initiative

·         ABPI publishes new roadmap to aid in ATMP development

·         Plasma-based engineering to accelerate antimicrobial material development

·         Reliable drug production requires fast and GMP-compliant labelling

·         TRexBio Announces Collaboration with Janssen to Discover Novel Targets for Immunology and Inflammation  


·         Guardtech Cleanrooms announces corporate restructuring after acquisition

·         UK regulator publishes guidance on use of real-world data to support clinical trials

·         Longest Running FDA-approved, University-associated CDMO in the US

·         Aragen Life Sciences to Acquire Intox Pvt. Ltd.

·         Genmab Gains Broad Access to Synaffix's ADC Technologies

·         Piramal Pharma Solutions Expands In Vitro Capabilities at Ahmedabad Site






Containment Isolators & Glove Boxes

Manufacturing and handling highly potent compounds requires specialized containment capabilities with respect to personnel, equipment and facilities. This, to protect the drug product, the operators and the environment. Most manufacturing processes for oral solid dosage (OSD) drugs require some level of containment. Nicomac is able to supply made in Europe equipment for solid forms with high containment capabilities or under isolators from OEB3 to OEB5. The Nicomac designed, complete line under isolators has been supplied with great success all over the world. Automatic and ergonomic sliding doors for an easy access to the isolators requiring less space. All round and smooth corners. High ergonomic handling inside the isolator: FBD container moving on rails from HSM to Mill, vacuum transfer from container to Mill and from Mill to Blender. Unique control system CFR21 part 11 compliant for all granulation line and isolators.

Containment glove box

·         Isolators for high containment designed for oel up to 0.1 μg/m3

·         Isolators for Dispensing- Sampling- QC

·         Containment glove box

·         Certified exposure device operator

·         Pass box

·         Material transfer technology

·         Split butterfly valves

·         RTP rapid transfer port technology

Nicomac and partner specialized in isolator technology joined their experiences, know-how and their talent to design, develop, manufacture and supply Isolation Technology to pharmaceutical companies all over the world.

Nicomac is the right solution if you are looking for isolators for solid forms

Nicomac has a specialized department with high expertise & exceptional skill on Isolation Technology for high containment

Nicomac success is due to the proven ability to produce advanced tailor-made solutions that meet client individual containment needs. Based on European technology, Nicomac started designing and manufacturing Isolators in 2004.

Nicomac has supplied and installed a completely contained granulation line with 5 kg capacity, for high potency products under isolator – OEL level of 0.1 µg/m3 in 8 hours. An ergonomic and high tech solution for:

·         Dispensing

·         HSM NicoMix

·         FBD NicoBed

·         NicoMill

·         Tumbler NiCO Mixers

·         Tablet press

·         NCS Coater

·         RTP Technology

CraneCPE has intelligent solutions for diaphragm valves

SaundersVUE  offers intelligent solutions for diaphragm valves specifically in the Life Science industry. The platform is designed to maximize plant efficiency by eliminating false alarms and reducing set-up times. SaundersVUE valve sensors provide a positive and accurate The SaundersVUE suite of intelligent products includes two valve sensors: • Saunders I-VUE: Valve solution for end users due to enhanced diagnostics and easy calibration • Saunders M-VUE: For equipment manufacturers due to its modular and compact design One feature that is present in both SaundersVUE products is the selfcalibration feature that holds potential for cost savings. Traditionally, switchboxes require two people for calibration, each taking around 30 minutes.

The maintenance personnel have to locate the valve sensor in the field, open the enclosure and then adjust the settings. This consumes a lot of time, increasing maintenance costs. However, with the new sensors, only one person is needed to calibrate a sensor. This process is very fast and efficient, taking only 3minutes, as the need to open the enclosure is eliminated because of the sensors’ contactless operation.

Validating safety of materials in single use filters


Dr Sade Mokuolu, group compliance manager, Watson-Marlow Fluid Technology Group has addressed  the importance of risk  assessment in qualifying SU components “As detailed in USP 661.1, passing the biocompatibility tests is not sufficient for a complete risk assessment to be performed. Understanding not just the material but the propensity for the material to leach unwanted and unknown chemicals into a drug product has been a requirement of the industry in recent times. This has been principally achieved through extractables testing.

As the analytical technologies have advanced, the techniques used to assess extractables and potential leachables has become highly developed. The analytical instruments are extremely sensitive and are able to detect the presence of compounds at levels in parts per billion (ppb). These technologies are a far cry from the wet chemistry tests reported in the previous compendia.By providing the level of technical/validation data about the component material to the drug manufacturer early on facilitates the adoption of SU technologies into drug processes faster.”Her complete paper is found at


Minimizing   pump pulsation negative impacts

Gary Gaudet of  DPS observes that “ there are two types of pulsation; flow and pressure,  both have an effect on the customers production, accuracy and reproducibility.  These effects can be minimized or amplified  by piping design and pressure control (i.e. Equilibar). This is required to properly make product (i.e vacines) or the increase yield in a chromatography step”

Gay adds “Using different types of motors make a difference in the performance of a pump. The two types of motors are  a digital/servo motor or a asynchronous motor. The digital motor does not only improve the accuracy of the pump but also it’s range. An example of this is, the  pump had an original turndown of  30 to 1,  now, it has greater than 300 to 1 turn down The   accuracy was increased from 1 ½% to  0.5%. This allows for better performance over a larger range for Inline Dilution and Chromatography skids“.

The example below shows two types of pulsation; flow and pressure,  both have an effect on the customers production, accuracy and reproduceability.  This is a low flow pulsation pump that has a high pressure pulsation.



Description automatically generated


Gay adds “Using different types of motors make a difference in the performance of a pump. The two types of motors are  a digital/servo motor or a asynchronous motor. The digital motor does not only improve the accuracy of the pump but also it’s range. An example of this is, the  pump had an original turndown of  30 to 1,  now, it has greater than 300 to 1 turn down The   accuracy was increased from 1 ½% to  0.5%. This allows for better performance over a larger range for Inline Dilution and Chromatography skids“


The next slide shows the difference between two types of motors on the same pump,


Chart, line chart

Description automatically generated

So, the pump types used depend on information or biases at the customers site.





Novo Nordisk plans $2.6bn pharma build with engineering partner NNE

NNE is Novo Nordisk's engineering partner from design to construction of this huge expansion and has already delivered the conceptual and basic design for the expansion of the Kalundborg site

Novo Nordisk has announced its plans to invest more than DKK 17 bn ($2.6bn) in construction of three new manufacturing facilities as well as expansion of one existing facility at the production site in Kalundborg. NNE is Novo Nordisk engineering partner from design to construction of this huge expansion, which signifies one of the largest projects in NNE history.

Novo Nordisk's investment will establish additional capacity across the entire global value chain from manufacturing of active pharmaceutical ingredients (API) to assembly and packaging, with the vast majority being invested in API capacity. These expansions will provide capacity for the production of Novo Nordisk's current and future oral and injectable products. The new facilities will be automated and include state-of-the-art production technologies

NNE has delivered the conceptual and basic design for the expansion of the Kalundborg site and will continue to act as Novo Nordisk's engineering partner for the coming phases. 

Record breaker

CEO of NNE, Jesper Kløve, is proud that Novo Nordisk has chosen NNE as it's engineering partner from design to construction, he said:"I would like to thank Novo Nordisk for entrusting NNE with the execution of this fantastic project, which is one of the biggest we have executed in NNE history. We will do our utmost to live up to all parameters."

Kløve explains that in the design, NNE have strived to take account of many different aspects. First and foremost, the company wanted to design facilities which are future-proof in terms of current and future demands for pharmaceutical production and filled with the latest technology. At the same time, NNE's focus has been to create an interior that ensures good working conditions in terms of space, flow and light for the employees who will spend their workdays inside the facilities. 

"Moreover, we have strived to achieve an architectural expression where the buildings look modern, but without drawing too much attention. One of the facilities had to fit in with the existing buildings, while another - the first large building to be established north of the railway - had to fit in with fields, railway and green surroundings," Kløve added. "We have done our absolute best and the future will tell if we achieved what we set out to do." 

Applying virtual reality in all project phases

NNE has been involved in the project from the early design phases and has from the beginning focused on using digital tools to support project execution and decision processes. 

Based on the digital 3D design model created for the project, NNE has created a collaborative tool based on virtual reality (VR), which allows several users to meet virtually inside the 3D design model and together perform design reviews and make decisions - regardless of where the participants are located physically.

In the coming construction phase, NNE will apply augmented reality (AR) technology, which makes it possible to review the design model onsite through an iPad or smartphone by adding a digital layer of information on top of reality. This makes it possible to identify and solve challenges on the spot by simply comparing the digital design model against the real-world design.


Britons expect continued collaboration in (bio)pharmaceutical research

Survey finds British adults expect pharma to continue to work together to advance both COVID-19 treatments and innovations for other diseases.

According to a survey, nearly a third of Britons are concerned continued COVID-19 vaccine and treatment research is sidelining innovations and progress on treatments for other diseases.

Additionally, 28 percent thought pharma and biotech companies need to play a stronger role in tackling vaccine inequity.

The research, an online survey of 2,241 British adults (aged 18 years and older), found that 55 percent of the population expect pharma and biotech companies to keep working together to continue developing more effective COVID-19 treatments and preventive care. However, 32 percent expressed concerns that the pandemic is causing researchers to sideline other key drug treatments/innovations unrelated to COVID-19.

In addition, the research found that many people felt their understanding of the pharmaceutical industry had improved since the start of the COVID-19 pandemic: 34 percent claimed to have a better understanding of how vaccines/treatments are developed and distributed, 34 percent of the approval process and 31 percent the use of clinical trials. However, just 27 percent believed they understand what messenger RNA (mRNA) vaccines are and how mRNA vaccines work.

Daniel Chancellor, Thought Leadership Director at Informa Pharma Intelligence, commented: “Over the last two decades, the number of treatments being designed using RNA technology have been slowly rising but were not widely known outside of scientific circles. The pandemic has changed this, as both industry and public recognition of the new vaccine class has grown – and the mRNA pipeline itself has tripled since 2019 to become one of the hottest areas of drug development. 

“Excitingly, the application of mRNA technology extends to the development of treatments for diseases that have evaded scientists for some time — take cancer or HIV, for example. Whilst the development of these is still in its infancy, highly specialist platform biotech companies are likely on a trajectory to producing effective vaccines across a range of new diseases.”

Half of survey respondents also believed that COVID-19 had forced pharma companies to speed up their pace of innovation in treatment and expect continued collaboration to expedite drug development in other areas (such as cancer and infectious diseases).

The report also reveals that Britons are fearful of Brexit and other factors disrupting access to medicines. Among the concerns were Brexit and border issues (53 percent), heavy goods vehicle (HGV) driver shortages (48 percent), general practitioner waiting times (42 percent), National Health Service (NHS) appointment backlog (41 percent) and the ongoing effects of the COVID-19 pandemic (36 percent). Concerns about Brexit threatening access to medicine and prescription drugs were significantly greater in Northern Ireland, with 69 percent of respondents indicating they were worried.


EMA launches the Regulatory Science Research Needs initiative

The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.

The European Medicines Agency (EMA) has for the first time issued a list of regulatory science topics that need further research to close gaps and improve medicine development and evaluation to enable access to innovative medicines for patients.

EMA has identified around one hundred specific topics in the Regulatory Science Research Needs list. These topics, and the initiative itself, emerged from the stakeholder consultations which underpinned the development of the Regulatory Science Strategy to 2025. EMA carried out interviews with chairs of its scientific committees and working parties, and also with external experts and opinion leaders from the principal stakeholder groups.  

For both human and veterinary medicines, the topics have been divided into four categories:

·         integration of science and technology in medicines development

·         collaborative evidence generation to improve the scientific quality of evaluations

·         patient-centred access to medicines in partnership with healthcare systems

·         emerging health threats and availability/therapeutic challenges.

EMA stated that, by publishing this list, it seeks to stimulate researchers and funding organisations to consider addressing these topics in their research agendas and share their findings and results with regulators. Moreover, EMA added that, by engaging in the Regulatory Science Research Needs initiative, researchers and funders will be able to see their findings translated into regulatory practice, medicines development and public health. The list will be also updated periodically with new topics and references to related research. 

“The acceleration of innovation in medicines development requires a parallel advancement in regulatory science,” EMA claimed in the report. “New technologies and evolving science throw up new regulatory questions and it is important that these questions are answered so that innovation is translated safely and swiftly into effective, high-quality therapies.

“Addressing the research needs in regulatory science requires a collaboration with both academia and key research funding bodies. While EMA may be able to fund a small portion of the research needs, external funding obtained by researchers will remain the primary pathway for addressing the research topics. To this end, EMA is committed to fostering a strong working relationship with European academicians and researchers as well as key research funding bodies, as part of the EMA’s Academia Action Plan,” the report continued.

A webinar to inform patients, academic and collaborative research groups, and health professionals is planned on 18 January 2022 to explain the Regulatory Science Research Needs initiative and how stakeholders can engage with it.


ABPI publishes new roadmap to aid in ATMP development

The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations. 

The Association of the British Pharmaceutical Industry (ABPI) and the Accelerated Access Collaborative (AAC) have launched a new roadmap to clarify the processes companies have to go through to get advanced therapy medicinal products (ATMPs) to market.

ATMPs, also known as cell and gene therapies, have the potential to save and transform the lives of some of the sickest patients and potentially cure them. However, the processes involved in getting them to market can be complex and difficult to navigate. 

Recognising their potential, the UK Government have established initiatives to make Britain a world leader in the sector; however, ABPI stated that more can be done to attract innovators to research, develop, manufacture and launch their products in the UK. 

“Our roadmap helps to demystify the often-complex processes that innovators face and is an essential tool for those launching products in the UK,” explained Dr Paul Catchpole, Value and Access Policy Director at the ABPI. It aims to clarify the processes involved with developing ATMPs and getting approval, as well as how to engage with the system. 

It highlights four key considerations when launching a product:

1.    Engage early with all parts of the healthcare system including the MHRA, NICE and NHS England – from early product development and regulatory stages right through to service planning and commissioning to make sure the system is ready.

2.    Keep the patient in mind throughout and talk to patient groups to keep them at the heart of development. Also, consider patient population diversity.

3.    Take advantage of all available guidance and support including what’s on offer from the NHS and other parts of the system partners who can help you understand the landscape and how to meet the specific requirements of regulators, commissioners, and providers.

4.    Aim for simplicity wherever possible and look for where things can be standardised. The health service already delivers ATMPs to patients, and companies should consider what they can do to make them fit existing systems and processes to speed up time to market and to patients.

Matt Newman, Deputy Director, AAC, added: “This is one aspect of a broader programme of work to ensure that the NHS is ready to adopt the latest ATMPs, building on the successful introduction of treatments like CAR-T [chimeric antigen receptor T-cell therapy].  

“Thanks to the new roadmap, ATMP developers have access to a rich source of information, in one place, set out in an accessible format. This first of kind resource will make the end-to-end pathway for ATMPs easier for developers to navigate, increase NHS adoption and make the UK an attractive place to launch ATMPs. Ultimately, the new ATMP Roadmap will support innovators in getting ATMPs to NHS patients faster.”

To download the roadmapclick here.


Plasma-based engineering to accelerate antimicrobial material development

Could plasma-based engineering provide a greener method to produce antimicrobial materials, such as contact-killing, antifouling and drug-release surfaces?

Biofilm of antibiotic resistant bacteria.


According to researchers, plasma-enabled surface engineering could advance antimicrobial material development, providing a less expensive and more environmentally friendly method than existing wet chemistry techniques. 

Antimicrobial resistance is a growing concern worldwide, and particularly hospital-acquired infections from surgical tools, implants and heavily touched surfaces. This has prompted the study of antimicrobial materials in recent year; however, the existing wet chemistry methods are often complex, time consuming and expensive. 

In a new tutorial published in in the Journal of Applied Physics, researchers from Belgium, Czech Republic, and Italy present a promising alternative: plasma-enabled surface engineering. 

“Plasma-based engineering is an inexpensive and environmentally friendly method, because it doesn’t require the use of solvents and can be scaled up to industrial production relatively straightforwardly,” stated co-author Anton Nikiforov of Ghent University’s Department of Applied Physics, Belgium.

The technology relies on non-equilibrium plasma, or partially ionised gas, that produces chemical reactions to change the properties at the material surface. The different temperature levels within the plasma – usually ionised noble gases, oxygen or air – create distinct chemical pathways. These reactions can also be manipulated by adjusting electric power for surface activation, coating deposition and surface nanostructuring of virtually any solid material. 

According to the authors, plasma-enabled engineering can create contact-killing, antifouling and drug-release surfaces. Contact-killing materials destroy micro-organisms through the microscopic spikes that puncture microorganisms on contact, with one study demonstrating that plasma-etched black silicon nanopillar structures were highly bactericidal against Staphylococcus aureus, an antibiotic-resistant bacterium.

Antifouling materials prevent microorganisms from accumulating on surfaces to form biofilms. For instance, plasma polymerised superhydrophobic thin coatings – water-repelling materials inspired by the lotus leaf – have also been extensively developed because the lack of moisture, prevents microorganisms from adhering to and reproducing on these surfaces.

Drug-release surfaces control the release of antimicrobial compounds, enabling high-dose delivery of antibiotics to target locations, an application that is useful after surgery. For example, vancomycin, a common antibiotic, was deposited inside spherical particles using aerosol-assisted plasma deposition

The scientists explained that numerous plasma-based methods have been developed to create such surfaces, including low-pressure and atmospheric pressure plasma etching, plasma polymerisation, sputtering, gas aggregation of nanoparticles, aerosol-assisted plasma deposition, and various combinations of the same methods.

However, they cautioned that, despite the promise of plasma-based engineering, certain limitations are yet to be addressed, such as understanding how bacteria adheres to surfaces and what takes place in the destruction of microorganisms.


Reliable drug production requires fast and GMP-compliant labelling 

Steierl-Pharma modernizes and optimizes labelling processes with inspection technology from OMRON 

Hardly any other industry is subject to such high-quality requirements and legal regulations as pharmaceutical companies. This applies to active ingredients, production and storage as well as to the labelling process. For example, the labels must be robust and stick reliably for the usability period of the drug of up to five years. Labels carry important information such as the name of the drug, active ingredient(s), manufacturer, and variable data such as expiration date, lot number, and serialization information, if applicable. Establishing a valid labelling process is key. At the same time, the processes should also be as efficient, fast and sustainable as possible.

Steierl-Pharma GmbH from Herrsching (Bavaria, Germany) relies on the support of OMRON automation experts in this regard. By using a new labelling system with smart camera technology, Steierl-Pharma can label its pharmaceuticals with high process speed and reliability. The labels are printed with variable data on batch designation, expiration date and if required, the dispensing notice "Sample not for sale". 

Steierl-Pharma is a medium-sized pharmaceutical company in the field of naturopathy and produces medicines in liquid dosage form, in cylindrical glass containers. The product range of the company, which was founded in 1949 in Munich by a pharmacist, includes medicines for the musculoskeletal system, for lowering blood pressure, for relieving migraines or skin diseases, or for treating flu-like infections. In addition, the pharmacists at Steierl-Pharma are continuously researching new naturopathic therapies and the use of medicinal plants ineffective and well-tolerated preparations. 

The producer has the legally required manufacturing license for medicinal products as well as the GMP certificate. Such Good Manufacturing Practices (GMP) certification guarantees process integrity in drug production and conformity with applicable regulations. When it comes to filling and packaging the drugs, Steierl-Pharma uses a production line designed for around 3,600 units per hour. It consists of a filling and capping machine, a labeler, and a packaging machine. The line ensures a continuous and seamless process consisting of filling and closing the bottles with a dropper insert and a screw cap. The closed bottles then leave the cleanroom and enter the labeler, where they are labelled and then packed in a folding box together with an information leaflet in the packaging machine.

Challenge: Avoiding unintentional machine stops and read errors

In 2019, a project team at Steierl-Pharma began initial considerations to introduce a replacement for an already older labelling machine. "The labelling machine used until then already had a smart camera-based inspection system to check the identity of the label and the variable data (batch name and expiration date). However, this had two drawbacks: First, labels were repeatedly misread as bad labels, and second, bad units were not rejected, but the labelling process was stopped. However, this meant that when the machine stopped, the bottles backed up into the filling machine, so that it also stopped, and the packaging machine ran empty. "So we had a 'bottleneck' in our process," reports Steffen Wegner, Managing Director of Steierl-Pharma GmbH.

Requirements: Precision and speed

Wegner explains: "That's why we worked with the manufacturer HERMA to find a suitable inspection system. The focus here was on high reliability and good pricing." The aim was to develop a labelling machine that on the one hand met the high requirements in the GMP area, but on the other hand, also ran without interruption during regular operation. One of the central criteria was that the new inspection system should work particularly precisely: bad units such as an incorrect or illegible barcode as well as batch or expiry date errors should be detected reliably, the keyword being sensitivity. At the same time, Steierl-Pharma wanted a high level of specificity: the system should only detect actual bad units as such and eject them from the process. But that's not all: with an output of around 60 labels per minute, the inspection system only has a time window in the range of milliseconds for the complex inspection tasks. 

FHV7 smart camera supports testing and quality control

The central component here is the inspection system. Wegner explains: "We decided on the OMRON FHV7 smart camera after a test on our label material on site, supported by an OMRON application engineer. We were effectively supported by OMRON throughout the entire development process up to commissioning and qualification of the machine and beyond." With the help of the FHV7, the HERMA labelling machine at Steierl-Pharma checks the identity of the label based on the pharmaceutical code and verifies batch and expiration via OCV (Optical Character Validation) for compliance with the specifications. The FHV7 series smart camera provides illumination and image processing functionality for enhanced visual inspections. Due to its world-first multi-colour light and a powerful high-resolution 12-megapixel camera, only a single FHV7 camera is needed to perform high-precision visual inspections of the production line.

During the performance qualification, which is part of the qualification of new machines in the pharmaceutical environment, the project managers involved were surprised by the extremely high specificity of the FHV7. "We could not believe how extremely reliable the OMRON FHV7 inspection system is. As part of the challenge testing, we deliberately introduced mislabels, all of which were reliably detected – but with a throughput of several 10,000 labels, not a single good label was incorrectly read as a bad label," reports Wegner. Even single faulty units could cause a lot of trouble in the GMP environment. By using the new camera, such situations do not occur, and the machine outages caused by the incorrect reading of actual good units can also be prevented.

Another advantage of the OMRON camera, in addition to its hardware, is the software, which is intuitive to use and does not require lengthy training. "I also really like the option of a customizable user interface, and so do the users. There is only one window in which, for example, the target code, batch designation and expiration date can be entered. Code verification and Optical Character Validation (OCV) can also be performed. It's all very clear and simple," explains Wegner. The software runs on any current Windows system and communicates directly with the FHV7 via the local network. Wegner also praises the high inspection speed of the OMRON system. The complex individual inspection of a label takes just 80 milliseconds: "That's impressively fast." 

Inspection system and support

"We are very satisfied with both the new labeler and especially OMRON's inspection technology. In a highly regulated environment such as the pharmaceutical industry, manufacturers must be able to fully rely on the technology that is used – also to be able to successfully complete the qualification. This is the case with us," Managing Director Wegner sums up. "The cooperation with the sales and application team was and is also excellent." Since the company has had such a good experience with OMRON, it is planned to convert an existing packaging machine to OMRON inspection technology within the near future.


TRexBio Announces Collaboration with Janssen to Discover Novel Targets for Immunology and Inflammation 

TRexBio Inc. has entered into a multi-year research collaboration and licensing agreement with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. This collaboration with Janssen Research & Development LLC will focus on the discovery of novel tissue-targeted therapeutics using TRexBio’s proprietary Deep Biology platform.

Under the terms of the agreement, TRexBio grants Janssen an option to an exclusive license to develop and commercialize therapeutics directed against selected targets that may arise from the collaboration, in exchange for an upfront payment, option fees, milestones and royalties.

TRexBio uses its unique platform to generate insights into human tissue immune-regulation and identify novel targets for therapeutics with a focus on modulating regulatory T cell (Treg) response. The TRex Deep Biology platform combines high resolution sequencing of human tissues, cutting-edge computational biology tools, and scalable translational biology assay systems into an optimized workflow, enabling efficient discovery and functional characterization of unique tissue-specific targets.

The companies will use TRexBio’s platform to discover novel targets that aim to address unmet needs in immune-mediated disease. Janssen will be solely responsible for the clinical development and commercialization of therapeutics resulting from the collaboration.

“We are extremely pleased to establish this strategic collaboration with Janssen,” said Johnston Erwin, CEO of TRexBio. “Our differentiated Deep Biology platform has the potential to uncover truly unique insights, and we look forward to leveraging this collaboration as part of our mission to bring new medicines to patients.”




Guardtech Cleanrooms announces corporate restructuring after acquisition

The company will now operate as five distinct separate divisions under a broader group

Guardtech Cleanrooms has announced the launch of the Guardtech Group, made up of five distinct divisions including the recently acquired Cleanroom Solutions and the introduction of the Isoblok.

The remaining three divisions include Guardtech Cleanrooms, which will now cater specifically for the modular cleanroom market as well as CleanCube Mobile Cleanrooms will continue to provide portable solutions for businesses. Isopod Rapid Cleanrooms will offer quicker, more flexible and cost-effective alternatives, using standardised models made from stock held by the company, available for flat-pack delivery and with the option for self-assembly installation.

Guardtech Group Chairman Ray Wheeler said: “As a board, we’re delighted to make this announcement – the business has evolved dramatically over the past five years and we’re so proud of everything that our team’s hard work has helped us build.

“Like many businesses, we’ve had some tough obstacles to overcome in that time and we’re confident this new structure is the ideal next step to take the company into an exciting phase of our development. I’d like to thank my fellow directors and everyone else on the team for all their brilliant efforts that continue to propel us towards new horizons.”

Conor Barwise, Guardtech Operations Director, said: “I’ve been here since the beginning of the journey and it’s amazing to see how we’ve grown in that time.

“We’ve had to overcome some serious hurdles, not least the pandemic in recent years, but the way we’ve managed to push on in a positive manner is a reflection of the flexibility and ‘can-do’ spirit of the whole team. I’m proud of everything the group has achieved so far and look forward to many more successes in the future.” 

The Group moved to acquire Cleanroom Solutions late in 2021, having followed the company for many years. Guardtech Group will now act as the parent company for five distinct businesses, but there is scope in the years ahead for even further additions.

Mark Wheeler added: “Restructuring the business provided a mechanism to differentiate between the variety of products and solutions that the Guardtech Group deliver whilst celebrating the joint identity and culture that is at the heart of all of these delivery formats. 

“The Guardtech Group is a collective of long-serving industry professionals that embrace problem-solving, innovative thinking and embody a determination to deliver the highest quality outcomes for a range of valued clients across the life science industries.

“At the heart of every decision the group makes is the newly established GUARD Charter, promoting the core values of guide, understand, adapt, respond and deliver. Each business within the Group and every employee working for Guardtech is held accountable against this charter and is guided to embody the values that have made our group strong over its history.”


UK regulator publishes guidance on use of real-world data to support clinical trials

Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.

The UK’s Medicines and Healthcare products Regulatory Authority (MHRA) has published new guidance on the use of real-world data (RWD) for randomised clinical trials.

The two guidance documents were drafted with the Commission on Human Medicines Real-World Data ad hoc group following consultation with industry. They provide considerations when planning a randomised clinical trial using RWD, with the intention of submitting this trial to gain a regulatory approval. 

The MHRA stated that using RWD – information generated during routine healthcare, including electronic patient health records, and disease and patient registries – to improve recruitment and aid regulatory decision-making could accelerate the development and approval of life-changing new medicines, making them available to patients more quickly.

While RWD is frequently used to monitor the safety of medicines and medical devices after they have gained approval, it is currently rarely used to demonstrate the effectiveness of an intervention before it is approved.

The new guidance is intended to be the first in a series addressing issues around using real-world evidence in support of a regulatory submission. It considers aspects related to clinical trial authorisation, clinical trial design (including choice of endpoints and safety data requirements), and requirements in terms of database quality and inspection. 

The two guidance documents are:

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

An introduction to the MHRA’s RWD guideline series, outlining points to consider when evaluating whether a RWD source is of sufficient quality for the intended use.

MHRA Guideline on Randomised Controlled Trials using Real-World Data to Support Regulatory Decisions

Guidance on considerations when planning a prospective randomised trial using RWD sources with the intention of using the trial to support a regulatory decision. The guideline covers clinical trial authorisation (if applying for approval to run such a trial wholly or in part in the UK), and clinical trial design including choice of endpoints and safety data requirements.

Commenting on the publication, Dr June Raine, MHRA Chief Executive, stated: “When used in this innovative way, real-world data has the potential to make a huge difference when it comes to bringing medicines through clinical trials to patients.

“With fewer or even no trial-specific visits, consenting trial participants do not have to travel long distances to get to their appointments. And with fewer logistical hurdles, real-world data could make it more feasible for trial sponsors to repurpose existing medicines for new conditions. 

“Because of this, and the growing need to find more cost-effective ways of conducting clinical trials, our new series of guidelines focuses on how to use real-world evidence to aid regulatory approval, helping to bring medicines to the patients who need them, sooner.”


Longest Running FDA-approved, University-associated CDMO in the US


Our experts are here to help clinical and commercial clients in developing formulations, manufacturing products, and conducting analytical testing for sterile and non-sterile projects.

What we do

Contract pharmaceutical services include:

·                     Pre-formulation studies

·                     Formulation development (including lyophilization cycle development)

·                     Clinical supply manufacturing and testing

·                     Small scale commercial manufacturing and testing

·                     Analytical method development and validation

·                     Routine quality control analysis

·                     Stability studies

·                     Active pharmaceutical ingredient (API) and excipient release testing


UI Pharmaceuticals is able to manufacture most dosage forms including sterile solutions and lyophilized powders; tablets; capsules; and non-sterile semisolids and liquids.


Aragen Life Sciences to Acquire Intox Pvt. Ltd.

Enables Aragen to conduct safety assessment studies from a GLP-certified facility for submission to regulatory agencies such as the U.S. FDA.

Aragen Life Sciences, a global research, development, and manufacturing services provider, has signed a definitive agreement to acquire Pune-based Intox Pvt. Ltd.
This acquisition will expand Aragen’s integrated discovery and development platform for the pharmaceuticals, biotechnology , animal health and agrochemicals industries. It will enable Aragen to conduct safety assessment studies from a Good Laboratory Practice ( 
GLP )-certified facility for submission to regulatory agencies such as the U.S. FDA , the U.S. Environment Protection Agency (USEPA), the European Medicines Agency ( EMA ), and others globally.
Intox is a GLP certified preclinical contract research organization ( CRO ) with its test facilities in Pune, India. It has conducted more than 15,000 GLP studies for global clients.
The acquisition will also expand Aragen’s geographical footprint in India. Aragen currently has research and manufacturing facilities at Hyderabad, Bengaluru and Vizag in India and a biologics facility in California, U.S.
Manni Kantipudi, CEO, Aragen Life Sciences, said, “Intox’s experienced scientific team has an excellent reputation for its scientific rigor and subject matter expertise, and I am delighted to welcome them into the Aragen family. This acquisition is in strategic alignment with our long-term vision to be a ‘one-stop’ integrated discovery, development and manufacturing partner to our customers. We can, now, rapidly and seamlessly, advance promising molecules for our customers, from early discovery to Investigational New Drug ( 
ind ) submissions, making Aragen one of the few global CROs that can advance programs from “concept- to- clinic”.
Dr. Narendra Deshmukh, co-founder and Director, Intox Pvt Ltd. said, “With over two decades of expertise, Intox is one of the most reputed GLP facilities in the country, trusted for the high-quality data generated by our scientists, which has helped our customers receive approvals from national and global regulatory agencies such as USEPA, USFDA, European Commission amongst others. We are delighted to be a part of Aragen and believe that the two organizations bring in complementary capabilities that will help in delivering long-term value to customers.”


Genmab Gains Broad Access to Synaffix's ADC Technologies

Secures rights for conducting research on ADCs against multiple drug targets under new licensing agreement.

Genmab and Synaffix have signed a license agreement providing Genmab broad access to Synaffix's ADC technologies. Genmab is granted exclusive research rights to utilize Synaffix ADC technologies for one drug target with the option for the worldwide development and commercialization of the resulting ADCs. Genmab has the option to exercise exclusive research and commercial licenses for additional targets.
For each specific target nominated under the license agreement, Genmab gains exclusive access to Synaffix's clinical-stage GlycoConnect 
Antibody conjugation technology, HydraSpace polar spacer technology, as well as select toxSYN linker-payloads, each designed to enable ADCs with best-in-class Efficacy and tolerability for the development of multiple potential therapies.
Genmab will be responsible for the research, development, manufacturing and commercialization of any resulting ADC therapies. At the same time, Synaffix will support Genmab's research activities, including manufacturing of components that are specifically related to its proprietary ADC technologies.
"At Genmab, we are committed to bringing differentiated medicines to patients, and we believe collaborations are foundational to accelerate innovation," said Jan van de Winkel, Ph.D., chief executive officer, Genmab. "We look forward to working with Synaffix toward our shared goal of developing best-in-class or first-in-class antibody therapies and make an impact on the lives of patients."
"In what represents our fifth Out-Licensing deal in the last six months, we are thrilled to partner with Genmab, an international Biotechnology company," said Peter van de Sande, chief executive officer of Synaffix. "In deploying our cutting-edge ADC technology platform together with Genmab's robust antibody development capabilities, Synaffix is privileged to once more play an essential role in strengthening a partner's pipeline with our innovative ADC technologies thereby aiding the transformation of cancer treatment."
Under the terms of the agreement, Synaffix will receive an upfront payment of $4.5 million and, on a target-by-target basis, is eligible to receive option-exercise, development-, regulatory- and commercial milestone payments. The total potential deal value is $415 million plus tiered, mid-single digit royalties on commercial sales.


Piramal Pharma Solutions Expands In Vitro Capabilities at Ahmedabad Site

Multi-million dollar investment to create a world-class high-throughput screening facility that will augment existing in vitro biology capabilities.

Investment augments in-vitro biology capabilities in primary and secondary screening at Ahmedabad site.


Piramal Pharma Limited’s Pharma Solutions (PPS) business, a Contract Research, Development and Manufacturing Organization ( CDMO ), has made a multi-million dollar investment to create a world-class high-throughput screening facility that will augment existing In vitro biology capabilities at its Drug Discovery services site in Ahmedabad, India. The expansion, which is expected to go live in 3Q22, will significantly add to the primary and secondary screening capabilities of compounds prepared at the site.
The benefits of this new investment include integrated chemistry and biology services from a single site, with anticipated significant improvements to drug discovery cycle times. New personnel with experience in biology services are also being added to the site team.
The new high-throughput screening technology enables PPS to evaluate and screen 1000 compounds per week using various 
Assay platform technologies such as Fluorescent Imaging Plate Reader (FLIPR), TR-FRET/HTRF, Fluorescence Polarization (FP), absorbance, Luminescence/ Electrochemiluminescence (ECL), Alpha Screen, Lantha Screen, Flow Cytometry, and high content imaging. These platforms will be applicable to a variety of targets (e.g., G- Protein -coupled receptors (GPCRs) and Kinase -targeted therapies). 
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions said, “Assisting customers in the discovery process is synergistic with our efforts to be a patient-centric CDMO. With this investment, we are enhancing our discovery platform by adding new in vitro biology services to our existing capabilities, making us a more integrated partner.”