Category Archives: Manufacturing

Sun Pharma drug combo scores FDA approval in advanced castration-resistant prostate cancer

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Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients.

Yonsa has been designed using Churchill Pharmaceuticals’ SoluMatrix Fine Particle Technology manufacturing process to offer a micronised formulation of abiraterone acetate tablets, allowing it to be more efficiently absorbed in the body. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).

As part of an existing deal between the pair, Churchill Pharmaceuticals will receive upfront, commercial milestone payments and royalties related to sales of the drug in the US, where Churchill will handle marketing duties.

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” commented Sun Pharma’s North American CEO Abhay Gandhi.

SOURCE: www.pharmafile.com/news/517442

Patient centricity: a winning formula

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Industry has taken a collective pause in an effort to re-evaluate and rethink longstanding approaches to drug development and commercialisation.

There has been considerable discussion about the concept of patient centricity in the pharmaceutical community, with attention being recalibrated on the ultimate goal — making it easier for the patient to reach improved health outcomes. This perspective is underpinned by the recognition that what is best for the patient will lead to beneficial outcomes for all stakeholders, including the drug company, the healthcare provider and the supporting community of associated service providers.

There is a famous quote from former United States Surgeon General, C. Everett Koop: “Drugs don’t work in people who don’t take them.” It is estimated that less than one third of all prescriptions written are actually filled at the pharmacy by patients. Wide-ranging studies have shown medication adherence rates for life-threatening diseases — including diabetes, heart disease and oncology — can be as low as 30–40%. With the benefit of interventional techniques and developing technologies, adherence rates have been shown to improve; however, these programmes are not broadly adopted within industry at scale and have neither significantly reduced the overall cost of healthcare nor benefitted large populations.

Patients may be non-adherent for a variety of reasons, some conscious and some unconscious. Certainly, we are all admittedly forgetful when it comes to taking our medicine on time or being diligent about timely refills of those prescriptions. Cost can also be a significant factor whereby patients will consciously stretch their medication supply or simply go off therapy. In either instance, doing so will hamper the health impact of their prescribed therapy or worse; taking a drug holiday while prescribed an anticoagulant could potentially put their life in jeopardy.

Other considerations may be unwanted side-effects or a lack of understanding about how to optimally take the medication, such as taking with food or alternatively avoiding food for some period of time, resulting in reduced effectiveness. Fear or general lack of understanding can also inhibit the path to improved health by affecting the patient’s perception of the medication and their willingness to be compliant.

Likewise, the patient may not physically experience the benefit of the drug and, in some instances, may have a negative perception owing to the unwanted side-effects. Hypertension is the classic example; the patient may have high blood pressure but generally not feel the effects of their disease. However, they may experience considerably unpleasant side-effects as a result of their course of treatment.

Likewise, a similar scenario plays out in popular cholesterol lowering medications. By scale, these two examples are noteworthy; in the US, with a population of more than 300 million people, of which 75% are adults, it is estimated that one in every three adults has hypertension, whereas 10–20% of adults have high cholesterol. A large-scale patient-centric approach to benefit medication adherence would have significant positive health and economic impacts.

Focusing patient centricity in clinical trials

In addition to challenges with patient adherence to medication in clinical trials, sponsors and study organisers are also constantly faced with hurdles such as patient recruitment and patient retention. As the industry is tasked with further expediting drug development and decreasing clinical study duration, FDA is increasingly requiring additional studies and further data to prove long-term safety and comparative effectiveness, including post-marketing studies once the drug is commercially available in the market.

This trend is coupled with an increasing percentage of drugs being brought to market for very specialised disease states and narrow therapeutic indications. This wave of specialised medicines and the ongoing need for treatment-naïve candidates, paired with cost pressures in the R&D sector, has increased the use of multinational studies. These complex studies in turn create the requirement for multilingual labelling. This can result in the creation of investigational medicinal product (IMP) study materials that may contain upwards of 16–20 languages on a single label.

Clinical trial professionals are left to balance all of these demands and creatively identify initiatives to keep the focus on the patient. At a surface level, these competing priorities may seem to be in direct conflict. However, when one looks at the situation from a broader perspective, the focus on patient centricity clearly generates tangible value and outweighs the short-term inefficiencies created by opting for a solution solely based on speed or cost.

Patient centricity in package design

A practical example of patient centricity in action can be found in package selection for investigational studies. When looking to initiate a clinical study, a sponsor company may be evaluating whether to choose a bottle or a unit dose blister in a calendarised format for their clinical study material.

Looking simply at the short-term criteria of expediting material for study initiation, when a difference of weeks or days can be considerable, the path of selecting a bottle would be a logical solution. It is a cost-effective packaging option, it is relatively “off the shelf” in its availability, it can be hand filled by a clinical packager with minimal start-up costs, has an acceptable stability profile for barrier properties and is child resistant.

Conversely, when evaluating the development of a unit dose adherence package, the company might find that it may involve a longer lead time for development and be more costly to produce. Looking from a short-term perspective and the immediate pressures of cost and expediting, the choice leaves little room for debate. However, if the sponsor company is taking a holistic approach with a focus on patient centricity, the broader economics absolutely point to the use of a patient-centric package.

Using a calendarised unit dose blister format or compliance/adherence packaging enables sponsor companies to both address the needs of the patient as well as positively impact the desire for better data, more efficient studies and lower total delivered cost. The use of this style of package allows patients to take medication exactly as prescribed and track their usage, rather than a bulk approach in a bottle format. Physicians can capture vital information on the package, including the specific date to start the therapy and any other pertinent notes for the patient. With the returned package, the patient can physically demonstrate to clinical providers that they have taken the product as prescribed. Furthermore, technologies are available that can provide real-time tracking of patient dosing, allowing for clinical interventions to ensure proper adherence while the study is in progress.

These technologies and principles extend to other delivery forms such as injectables. The ability to prompt, monitor and even track real-time information is a powerful tool. Likewise, with the advent of Bluetooth and nearfield communication technologies, packages with integrated technology can capture real-time information about side-effects or other vital information as patients take the medication during the course of treatment. Better adherence leads to healthier patients and more valuable study data.

Poor adherence can be rectified and corrected as it happens. Better information gathering can lead to improved patient retention, a significant cost in clinical trial administration and a persistent challenge in study duration. It is estimated that, in the industry, clinical studies on average have a 30% drop out rate. With more adherent investigational study patients, health outcomes are improved and better retention is realised, translating into reduced total delivered cost, more valuable data generated and studies executed more efficiently.

Patient centricity in clinical supply chain logistics

Another focus point for realising patient centricity in clinical trials is in the area of study design and administration. Considerable interest is being focused on Direct-to-Patient models, in which patients may minimise or in some instances avoid the need to come to a hospital or clinic to receive the study drug, as well as provide critical health feedback. In this scenario, patients are engaged by clinical trial or healthcare professionals in a home setting and the study drug is physically delivered to their home by a trained specialist. Clearly, this model is not applicable for all studies and disease states, but for certain programmes there can be considerable benefit to the patient and the study.

In certain geographies, patients in a traditional clinical study may have to travel significant distances to participate, which can considerably hamper patient recruitment and retention. In a Direct-to-Patient model, the study effectively comes to them. This model may increase the cost of study administration for the sponsor company; however, by executing the study in a more patient-focused approach, the sponsor company can realise significant benefit through patient recruitment and retention, again translating into better data, more efficient studies and a faster path to completion.

Patient centricity in a global world

One of the increasing challenges in taking a patient-centric approach to clinical study execution is the growth in multinational study execution. Often, supplies are designed to pool, so that multiple languages are provided and materials can be directed to individual countries as needed.

This scenario forces sponsor companies to either manage a multitude of language-specific supplies or focus on common supplies — whereby they condense information owing to the shear amount of text being added, often squeezed into a multi-page booklet.

Careful consideration must be paid to graphics that are common to all languages and cultures to ensure patients can clearly comprehend considerably distilled opening instructions, dosing regimens and other key information. Rather than a traditional pooled supply approach, some companies have developed newer strategies for just-in-time (JIT) labelling or late stage customisation logistics, whereby they label study materials according to country specific requirements at the time of drug dispatch.

This can reduce the complexity of a scenario in which they would be trying to accommodate 16 different languages on the same label in a multi-page booklet approach. This JIT strategy might decentralise supplies but may bring other benefits, such as meeting the language and cultural needs of patients in their geography, as well as those of the study administration.

Patient focus yields powerful results

The industry is only in the infancy of its journey towards patient centricity; but, it is clear that with a focus on the patient, many tangible benefits can be realised by drug companies in the development and commercialisation of life-saving medicines.

With so many significant breakthroughs during the past decade, it is exciting to see where this patient focused journey will lead as new patient breakthroughs are happening every day.

SOURCE: www.manufacturingchemist.com/news

AZ’s potassium drug Lokelma finally approved in US

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AstraZeneca badly needs new drugs on the market as several former blockbusters have been hit by generic competition – and finally its high potassium treatment Lokelma has been approved by US regulators.

The drug, a highly selective potassium-removing agent, has been approved at the third time of asking by the FDA, which had been concerned about issues at its manufacturing plant in Texas.

European regulators approved the drug formerly known as ZS-9 in March after their concerns over the issues were resolved, and after two previous rejections the US regulator is also satisfied with the technical arrangements at the facility.

AZ gained rights to the drug after buying ZS Pharma in 2015 for $2.7 billion and is designed to treat hyperkalaemia, where high potassium levels threaten kidney and heart function.

Lokelma (sodium zirconium cyclosilicate) will compete with Vifor Pharma group member Relypsa’s rival Veltassa (patiromer), which has been on the market for a few years in the US and Europe.

The Anglo-Swedish pharma has predicted sales in excess of $1 billion annually for ZS-9, although some analysts say this is a conservative estimate.

The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.

Sean Bohen, chief medical officer at AstraZeneca, said: “The consequences of hyperkalaemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.”

AZ badly needs the new sales – sales of its Crestor (rosuvastatin), a former blockbuster were down 38% in Q1, to $338 million, and overall revenues fell 4% to just under $5.2 billion.

The company is selling off its old and unwanted drugs to prop up revenues and reduce costs – but this can only be seen as a short-term measure before new revenues come on stream.

CEO Pascal Soriot also faces a shareholder revolt, after more than 37% of shareholders voted against or abstained at the firm’s annual meeting when asked to approve a £9.4m pay package for Soriot, down from £14.3 million last year.

Soriot has set a sales target of above $40 billion by 2023, despite the struggles getting new drugs to the market.

SOURCE: www.pharmaphorum.com/news

Celebrating 15 years of life-saving technology

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The experts in temperature controlled packaging Peli BioThermal, are celebrating 15 years of the Original Golden Hour container, developed to provide blood to critically wounded soldiers.

The award-winning Original Golden Hour container – the company’s flagship product – was recognised in 2003 as part of the US Army’s Greatest Inventions programme, has gone on to shape future product development, influencing the full range of Peli BioThermal reusable and single-use products.

“We developed the Original Golden Hour to address a critical need facing our military personnel — how to make blood available to treat the critically wounded within the crucial first hour after injury,” explained Kevin Lawler, Peli BioThermal VP of sales, “Today, the technology behind this product allows us to provide reliable temperature control not only for blood on the battlefield, but also for life-saving civilian applications, including the transport of biologics and temperature sensitive pharmaceuticals for clinical trials and commercial distribution.”

The technology is incorporated in a range of Peli BioThermal products, which are utilised by emergency first responders globally.

In 2003, the US Army needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The answer, The Original Golden Hour container was the answer to a proposal from the US Army in 2003, when they needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The container was subsequently included as part of the 2003 US Army’s Greatest Inventions program by the US Army Research, Development and Engineering Command (RDECOM) Public Affairs office.

“If you can make sure that someone doesn’t bleed out by giving a resupply of blood right there, you’ve exponentially impacted the ability to save that soldier’s life,” said sixteenth chairman of the joint chiefs of staff, retired US Marine general, Peter Pace, who also serves as chairman of the board for Pelican Products.

It truly makes a difference on the battlefield. And that’s as true today as it was 15 years ago.”

Patented Golden Hour Technology provides superior thermal protection for high value temperature-sensitive payloads between 2 and 1686 liters, from -50ºC to 25°C for up to seven days (168 hours). Today, Golden Hour Technology is integral to all of the company’s products, including reusable products like the Credo Cube shipper and the Credo ProMed series, as well as the Chronos range of single-use shippers.

SOURCE: www.manufacturingchemist.com/news

In Europe, Mylan’s rivals try to plug EpiPen shortages

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LONDON (Reuters) – European makers of emergency allergy treatments are stepping up production of alternative life-saving adrenaline shots to try to fill intermittent shortages of Mylan’s (MYL.O) market-leading EpiPen injection.

Mylan began warning about EpiPen supply constraints in Britain two months ago. Canada has also seen similar problems, while on Wednesday the Food and Drug Administration added EpiPens to its list of drugs in shortage in the United States.

The shortfall reflects manufacturing delays at Pfizer’s (PFE.N) Meridian Medical Technologies unit, which is Mylan’s manufacturing partner and produces all the EpiPens sold globally at a single plant near St. Louis.

Allergy charities said there were anecdotal reports of some patients having difficulty filling prescriptions but there did not appear to be major supply issues overall, thanks to the availability of rival products.

Jext and Emerade, from ALK-Abello (ALKb.CO) and Valeant’s (VRX.TO) Bausch+Lomb unit respectively, are sold in both Britain and parts of Europe, while Lincoln Medical makes Anapen for certain European markets outside the UK.

“ALK has increased its production,” a spokesman for Denmark-based ALK-Abello said on Thursday. “We are doing all we can to meet the increased demand. We can make up some of the shortfall but not all, as EpiPen has a market share of around 70 percent.”

Lincoln Medical said it had not yet seen any major impact in Europe, reflecting the fact that the market was cushioned by multiple sources of supply and by the stocks held at distributors.

A spokeswoman for Britain’s health department said “limited” supplies of standard-dose EpiPens were available and stocks were being closely managed to ensure pharmacies could fulfil prescriptions. Supplies of half-dose 0.15 mg EpiPen junior have not been hit and remain readily available.

“Any patient who is unable to obtain supplies of EpiPen 0.3 mg should speak to their doctor about using an alternative,” she said.

EpiPens and other competing devices deliver doses of adrenaline via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction, such as to bee stings or exposure to peanuts.

SOURCE: www.uk.reuters.com/article

New partnership offers improved serialisation support

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Pharma customers can now experience track and trace systems first hand in a production facility, following a partnership between Mettler Toledo and R-Pharm Germany.

Product inspection specialist Mettler Toledo and contract manufacturer R-Pharm Germany are working together under a new partnership agreement to provide pharmaceutical customers with the support they need in the conception and planning of serialisation and aggregation solutions.

As a result of the collaboration, customers can now experience track and trace systems first hand in a live production facility, enabling them to understand the available options and develop solutions to meet their specific requirements more effectively.

Implementing or upgrading serialisation systems is becoming more time-critical as the industry prepares for compliance with the Falsified Medicines Directive, which comes into effect in February 2019.

In addition to helping customers develop their own track and trace solutions, the R-Pharm facility – equipped with the latest Mettler Toledo technology can also provide a bridging service for pharmaceutical customers until their own plant is upgraded.

Contract manufacturer R-Pharm, once part of the Pfizer production network, has been implementing Mettler Toledo systems and solutions for guidance-compliant serialisation and aggregation of pharmaceutical packaging for more than 7 years.

In that time, nine packaging lines at its Illertissen, Germany plant have been updated to offer more flexible operation and rapid product changes. As a result, all of the globally valid scenarios for pharmaceutical coding can be realised at this one site. Because R-Pharm works for many different clients, particular value is placed on flexible data management in the selection and implementation of the solutions from Mettler Toledo.

“Our clients expect from us a direct connection to their own ERP or MES systems, or would like to use serial numbers of cloud systems such as Tracelink,” explained Michael Unbehaun, Engineering Manager at R-Pharm.

“Therefore we make sure that our software systems are always state of the art and successively expand the interface palette. In this way, we can ensure efficient and rapid onboarding of new clients and enable them to exploit the potential of our lines.”

The new partnership agreement ensures that the experience gained by R-Pharm and Mettler Toledo in recent years are passed on to its customers.

Interested parties can now see – live in the production plant – the performance and functional scope of the PCE systems within the framework of reference visits at R-Pharm.

Accompanying presentations provide visitors with comprehensive background information on conception and implementation options and inform them of the organisational requirements that R-Pharm uses in the implementation of global track and trace orders.

R-Pharm and Mettler Toledo have now also started to offer combined workshops to provide a more intensive discussion of selected topics, from line integration and its process organisation to data exchange with cloud providers.

For those who want to delve even deeper, subject-specific training will be offered via a new T&T User Academy, including sessions on topics ranging from the development of standard operating procedures to pharmaceutical validation of machines or OEE management tactics.

SOURCE: www.manufacturingchemist.com/news

More than 400 jobs to be created by Dundalk’s “Factory of the Future”

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The move will see the creation of a further 700 construction jobs.

400 new, high-skilled jobs will be created over the next five years in Dundalk, Co. Louth after it was confirmed that a Chinese bio-manufacturing company will be investing €325 million into the creation of a new drug substances manufacturing facility in Mullagharlin.

WuXi Biologics is a Shanghai-based and Hong Kong-listed biologics technology firm, which provides pharmaceutical and biotechnology companies services to develop and manufacture biologics.

The facility is situated on the Industrial Development Authority’s greenfield site in Mullagharlin, Dundalk and will be the company’s first site outside China.

Launched on Monday, 30 April in Dundalk, Taoiseach Leo Varadkar said: “This is the start of something special.”

“We will see the Factory of the Future, right here in Dundalk. It’s the first sizable Greenfield project from China in the pharma sector and I am delighted to see it located here in Dundalk. It’s also the latest in a number of investments in this town which has become a hub for a range of sectors, mainly in the new knowledge based and pharmaceutical sectors.”

Minister for Business, Enterprise & Innovation, Heather Humphreys TD said: “This investment will result in the creation of over 400 highly skilled jobs over 5 years as well as approximately 700 construction jobs.

“This development is a further example of the success of our commitment under the Regional Action Plans for Jobs to provide quality jobs in regional locations.”

Dr. Chris Chen, CEO of WuXi Biologics later added: “We are all excited to initiate our first global site to enable local companies and expedite biologics development in Europe.

“In addition, this is the start and a critical part of our global biomanufacturing network to ensure that biologics are manufactured to the highest quality and with a robust supply chain to benefit patients worldwide. We are committed to Ireland and will work with all local partners to build this state-of-art next generation biomanufacturing facility as a showcase to the global biotech community.”

SOURCE: www.joe.ie/news/400-dundalk-chinese-biotechnology-624392

Method to predict drug stability could lead to more effective medicines

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Researchers have developed a new method to predict the physical stability of drug candidates, which could help with the development of new and more effective medicines for patients.

Researchers from the UK and Denmark have developed a new method to predict the physical stability of drug candidates, which could help with the development of new and more effective medicines for patients. The technology is being developed for use in the pharmaceutical industry in order to make medicines that are more easily released into the body.

The researcher’s method solves an old problem: how to predict when and how a solid will crystallise. Using optical and mechanical measuring techniques, they found that localised movement of molecules within a solid is ultimately responsible for crystallisation.

Solids behave differently depending on whether their molecular structure is ordered (crystal) or disordered (glass). Chemically, the crystal and glass forms of a solid are exactly the same, but they have different properties.

Molecules in the glass form are more readily absorbed by the body because they can dissolve more easily

One of the desirable properties of glasses is that they are more soluble in water, which is especially useful for medical applications. To be effective, medicines need to be water-soluble, so that they can be dissolved within the body and reach their target via the bloodstream.

“Most of the medicines in use today are in the crystal form, which means that they need extra energy to dissolve in the body before they enter the bloodstream,” said study co-author Professor Axel Zeitler from Cambridge’s Department of Chemical Engineering & Biotechnology. “Molecules in the glass form are more readily absorbed by the body because they can dissolve more easily, and many glasses that can cure disease have been discovered in the past 20 years, but they’re not being made into medicines because they’re not stable enough.”

After a certain time, all glasses will undergo spontaneous crystallisation, at which point the molecules will not only lose their disordered structure, but they will also lose the properties that made them effective in the first place. A long-standing problem for scientists has been how to predict when crystallisation will occur, which, if solved, would enable the widespread practical application of glasses.

“This is a very old problem,” said Prof Zeitler. “And for pharmaceutical companies, it’s often too big of a risk. If they develop a drug based on the glass form of a molecule and it crystallises, they will not only have lost a potentially effective medicine, but they would have to do a massive recall.”

In order to determine when and how solids will crystallise, most researchers had focused on the glass transition temperature, which is the temperature above which molecules can move in the solid more freely and can be measured easily. Using a technique called dynamic mechanical analysis as well as terahertz spectroscopy, Prof Zeitler and his colleagues showed that instead of the glass transition temperature, the molecular motions occurring until a lower temperature threshold, are responsible for crystallisation.

These motions are constrained by localised forces in the molecular environment and, in contrast to the relatively large motions that happen above the glass transition temperature, the molecular motions above the lower temperature threshold are much subtler. While the localised movement is tricky to measure, it is a key part of the crystallisation process.

Given the advance in measurement techniques developed by the Cambridge and Copenhagen teams, drug molecules that were previously discarded at the pre-clinical stage can now be tested to determine whether they can be brought to the market in a stable glass form that overcomes the solubility limitations of the crystal form.

“If we use our technique to screen molecules that were previously discarded, and we find that the temperature associated with the onset of the localised motion is sufficiently high, we would have high confidence that the material will not crystallise the following manufacture,” said Prof Zeitler. “We could use the calibration curve that we describe in the second paper to predict the length of time it will take the material to crystallise.”

SOURCE: www.europeanpharmaceuticalreview.com/news

Green Leaf Farms receives expanded cultivation site approval

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US manufacturer of cannabis products has begun operations in a state-of-the-art facility.

Green Leaf Farms, a US-based manufacturer of medical and recreational cannabis products, has received approval for expansion of its state-of-the-art facility and commencement of operations in an additional cultivation site.

Both sets of permits were tied together, the company said, due to the complexity of the structural and mechanical engineering that was needed to integrate the operations.

Based in Denver, Green Leaf Farms is a Division of Player’s Network (PNTV). The company took home the approved building permits for Phase Three development of its production and cultivation build-out, and officially began operations in an 8000 ft2 cultivation room. The site was completed last November.

According to PNTV, the expanded building has been designed to develop new products that will differentiate Green Leaf Farms in the emerging legal marijuana industry.

The expansion includes a state-of-the-art cleanroom, genetics lab, development laboratory, an extraction facility, a commercial kitchen, product development space, automated water purification including custom dosage and nutrient centre, a bio-testing facility, curing, packaging, and media centre.

“These design approvals will allow Green Leaf Farms to complete its build-out and become what I believe will be among the most advanced marijuana production and cultivation facilities in the world,” said Mark Bradley, CEO at PNTV.

“We have combined technology with an amazing, creative workspace that will encourage innovation, product development, differentiation and operating efficiencies.”

Green Leaf Farms has announced that further details of the expanded cultivation and manufacturing facility will be disclosed in due course.

SOURCE: www.manufacturingchemist.com/news

Carrying the torch for scientific glassblowing

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Walk into a chemistry lab anywhere in the world and you are bound to find an array of glassware being used for all manner of experiments.

Glass has many properties that make it useful for scientific applications, such as good chemical resistance and being transparent and good for heat transfer.

But, despite the important role glass plays in science, the skill to develop the glassware is in decline. Scientific glassblowing has now been classed as an endangered craft by The Radcliffe Trust.

Becoming a skilled glassblower can take as long as a decade according to Radleys Workshop Foreman Paul Robson.

He has been glassblowing for 40 years but his interest in the profession goes even further back. He said: “It was a demonstration with the scouts that kind of stuck with me. Later I attended a course at Braintree Technical College.”

Talking about the craft, Paul said: “It has been in decline because things have changed. The demand for glassware has declined because of alternative materials being available and new chemistry techniques being used.”

“Training has changed, too, and there are no more courses at colleges. You have to go to a local company and learn on the job.”

To help tackle the issue, Radleys has just started its own training programme. Radleys foundations lie in glassblowing and it is still an important part of their business.

Craig Joyce is the first apprentice to join the training programme at Radleys, which takes about 3–5 years. He fell into the job by chance when he was looking for a change after years spent mostly working in customer services at bars and restaurants.

The position caught his eye when he was job hunting. He said: “It looked really interesting. I’ve always liked making things and I like doing DIY at home. I originally worked as a workshop assistant for 6 months before I was offered the apprenticeship.”

Now he is several months into the apprenticeship and is enjoying using his new skill. He said: “I think it’s amazing what you can do with glass and I really can’t speak highly enough of my mentor. I enjoy coming to work every day.”

Craig’s scientific glassblowing apprenticeship combines following a detailed training programme with actually manufacturing items and components for sale. He routinely makes test tubes and adaptors and is building the skill through training to make more complex equipment like jacketed coil condensers.

“It can be very frustrating if you don’t do something right. You can burn yourself, or the item you’re working on can easily crack, or break. You have to be patient, have your eye on the ball and pay attention to minute details.”

But he is spurred on by the thought that the glassware he produces helps scientists all over the world do critical work.

“I like to think what I’m doing makes a difference,” he said.

As well as working on orders from their glassware catalogue, Radleys also deals with bespoke requests from scientists who need a specific piece of glass to help them solve a problem. Paul said: “The bespoke requests are very technical, you have to be determined because it can take a long time to finish what you are making.”

Being dexterous and having the ability to concentrate are just some of the qualities scientific glassblowers need. “You have to be a certain sort of person; perseverance and concentration are important,” Paul said.

You also need to get your head around more technical aspects such as engineering tolerances. Scientific glassblowing doesn’t leave much room for error. If you are not precise, you could end up producing a piece of equipment that isn’t fit for purpose, or is unsafe to use.

Trainees start of by mastering basic techniques, such as joining two pieces of glass, which in itself can take a while. A lot of the process involves benchwork, which’s done by hand with a flame. This gives them a hands on feel for how glass reacts. For example, when it’s molten hot, it follows gravity.

They then learn how to put all that they’ve learnt together. Everything they make needs to go into an oven to be annealed at 570 °C.

They use the raw material Borosilicate, also known as lab glass, or Pyrex glass to laypeople. The glass is usually imported from Germany because they are world leaders in producing it.

A lot of Radleys glasswork involves making reaction vessels for pharmaceutical or polymer companies. Paul’s work as Workshop Foreman also includes dealing with health and safety, technical issues and quality assurance. He leads a team of eight glassblowers.

During his time as a foreman, he has noticed it has become difficult to find trainees. “There is so much scope for other things. Manual skills aren’t at the forefront of young people’s minds.”

But even with the rise of automation, the human touch is still needed for glassblowing. Paul said: “You can use machines for holding hot stuff but you still need a person to do the job.”

Paul estimates there are fewer than 300 glassblowers in the UK. The British Society of Scientific Glassblowers is one of the places the small community can turn to for support.

“They help if we are stuck and they have a good library of resources, including videos,” Paul said. At the society’s latest symposium, Radleys won best in show.

If you think you’ve got what it takes to become a scientific glassblower, and are interested in starting your career with us, then please get in touch. Radleys are always on the lookout for talented people to join our expanding business, from trainees to expert glassblowers.

SOURCE: www.manufacturingchemist.com/news