The key to pharmaceutical manufacturing success in 2016
What’s hot for 2016? Lu Rahman asks key industry players what they think the key pharma trends will be for the coming year
Certain topics within pharmaceutical manufacture remain year on year. Companies continue to address issues of quality, counterfeiting and adherence while innovating with formulation and ingredients – all this while maintaining a competitive edge and offering a customer-focussed service. Innovation is always vital in this global industry - last year we saw the digital health sector impacting on pharmaceuticals and this trends looks set to have increased significance in 2016.
Wearable devices allowing the self-administration of drugs at home are becoming increasingly commonplace. Add to this the development of the first digital medicine product which addresses issues surrounding adherence, and the things are continuing to look very exciting indeed in this space.
As always, the industry’s key players have their own opinions on the trends that will be big news in 2016. Elliott Berger VP global marketing & strategy at Catalent Pharma Solutions says: “2016 will see continued pressure to make pharma companies’ R&D functions more productive and efficient, combined with the need to progress the best drug candidates faster, and with lower risk of failure. As a result, we envisage the growing importance of quickly selecting the most appropriate drug delivery technologies and driving integrated development processes to get better treatments though trials, and ultimately to patients.”
Reflecting this market outlook, the company has introduced the OptiForm Solution Suite to help develop and deliver optimised dose forms of API molecules using superior delivery platforms, and providing optimal animal PK materials in just twelve weeks.
Regulation
The issue of regulation is always on the agenda in the pharmaceutical sector. An increasingly stringent regulatory environment places ongoing pressure upon pharmaceutical manufacturers globally.
Analytical and bioanalytical contract solutions provider SGS Life Science Services has had a productive 2015. It spent the summer planning the opening of a new bio/pharmaceutical quality control laboratory at Villeneuve La Garenne, replacing the existing Clichy facility.
The new facility supports biologics development in the French market, reducing sample processing times through increased operational efficiency. It also offers services for the growing biopharmaceutical pipeline with capabilities for mycoplasma tests and amino acid analysis.
The company also completed construction of its, China, cGMP chemistry and biotechnology testing laboratories.
Ferdinand Dabu, marketing director, SGS Life Science Services, recognises the importance of regulation in the company’s work. Looking ahead to what the coming year holds, he says: “A recurring response from our lab network involved an increasingly tough regulatory environment. Specifically, stricter regulations from local authorities are pushing manufacturers in Asia to meet international standards. Additionally, we anticipate continued interest in elemental impurities as USP <232><233> are now in force for new products (2016 for EP 2.4.20 and 5.20) and will be required for existing products in late 2018 (2017 for EP). Next, with many biosimilars in development, expect to see more making it to market with the evolution of the regulatory environment in the US.”
Dabu also foresees the trend of drug/delivery device combinations to continue, shifting the paradigm in how these products are tested.
Counterfeiting
Counterfeiting is a serious issue within the pharma sector, costing the sector significant amounts of money annually. Any drug or medicine that contains the wrong or ineffective ingredients can have a harmful effect on an individual’s safety.
Richard Nemesi, global marketing manager for pharmaceutical and medical devices, Videojet Technologies, told EPM last year that, “counterfeit drugs cost the pharmaceutical industry billions of dollars each year and can erode priceless commodities – brand reputation and consumer trust”.
According to Nemesi, due to the Falsified Medicines Directive (FMD) deadlines in 2018, large pharmaceutical manufacturers are already implementing serialisation capabilities into production. He sees this trend continuing into the coming year. He also expects to see smaller organisations such as contract packagers start putting the wheels in motion to serialise their packaging lines.
“The Delegated Acts have been adopted by the European Commission and are expected to be published early 2016. What is perfectly clear is that a coding solution for FMD will need to feature robust data management, seamless integration into manufacturing equipment and high resolution print capability to convey information throughout the supply chain,” he states.
Ian Lemon, global product director, health & personal care, Essentra, agrees on the industry’s need to counteract counterfeiting.
“With the continuing rise of illegal counterfeit drugs and the upcoming Falsified Medicines Directive, expect an increased focus on security and anti-counterfeiting in 2016. Key focus areas will be track-and-trace - using unique identification numbers to monitor a drug’s journey from supply chain to consumer distribution - and tamper verification in a number of forms, such as labels, cartons, tear-tapes and seals.”
Lemon believes that in order to achieve the highest level of protection, however, companies should use a multi-layered approach incorporating serialisation, tamper verification features and overt/ covert authentication solutions.
Peter Sheppard, Genpact, is also clear on the importance of serialisation. “Product serialisation and tracking capabilities will bring new insights to the commercial side and attack working capital. The HCP experience will improve through a 360-degree engagement across R&D, medical and finance. Integrated, personalised interactions with patients, consumers and customers will deliver better care and breakthrough insights for both R&D and commercial.
“ The winners will build lean processes designed from the perspective of patient and customer outcomes, unconstrained by internal boundaries. Implementation success will depend on robust back-office integration.”
Adherence
Globally, adherence is an ongoing issue for pharmaceutical companies and individuals. Last year the FDA accepted the first digital medicine product combining a drug with an ingestible sensor to create a combination product, Abilify. One of the key benefits of this technology is its ability to aid adherence.
William Carson, president and CEO of Otsuka Pharmaceutical Development & Commercialisation, the makers of Abilify, said: “Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression.
“We believe this new digital medicine could revolutionise the way adherence is measured and fulfill a serious unmet medical need in this population.”
In 2003, the World Health Organization (WHO), indicated that ‘Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments’ ("Adherence to long-term therapies: evidence for action", 2003).
According to Jérôme Empereur, CEO, Stiplastics, in light of the WHO recommendation, and at a time when outpatient services are becoming the preferred option and patients are being encouraged to take more responsibility, it will be increasingly important to find ways of managing and monitoring patients’ treatment at home.
“Indeed, it is estimated that in developed countries, one patient in two with a chronic disease fails to follow their treatment correctly (forgetting, taking their medication late and so on). Pharmaceutical laboratories are fully aware of this and will be relying increasingly on the development of the internet of things and the technologies associated with it to develop smarter and more effective packaging to benefit both patients and stakeholders involved in health.
“The combination of electronics and plastic – the plastronics already widely used in the automotive industry – offers the potential for multiple solutions, such as an alarm to indicate when a dose should be taken, the box unlocking at the right time, feeding information back to a third party to confirm that the patient has taken their medication, etc.
“Connected pill dispensers undergoing clinical trials are generating data that could also be used to adjust treatment based on observance, to administer the ideal dose required to achieve the best possible result.”
According to Empereur, 2016 will mark the arrival of smart packaging for the pharmaceutical industry.
Formulation
Last year Dr Julien Meissonnier, Pharmaceutical Softgel Europe, Catalent looked at lipid-based formulations to increase the bioavailability of poorly soluble drugs.
He highlighted how poor solubility remains an ongoing challenge in formulation development. The number of poorly soluble compounds is estimated to be 40% of molecules on the market, however, more than 70% of drugs in development are classified as poorly soluble.
According to Zak Yusoff, senior product development manager SP Scientific, Lyophilised Antibody Drug Conjugate (ADC) and highly concentrated protein formulation will continue to gain momentum in 2016 with more products approval expected.
He adds: “In order to meet global medicinal needs, the pharmaceutical industry continues its quest for robust and fast lyophilisation processes to bring these products to the end users faster and safer. To meet this demand, adoption of existing technology such as controlled ice nucleation technology with the goal to improve product quality attributes and use of other process analytical technology tools will become more prevalent. Companies are investing more in education for their scientists to realize these goals.”
Jan Vertommen, senior director, product development & manufacturing, Capsugel, believes that innovation in improving the bioavailability of compounds will continue to be a central challenge for the pharmaceutical industry in the year ahead.
“Today, more than 60%of compounds in early development exhibit low bioavailability, and many compounds already marketed exhibit bioavailability challenges and can benefit from an optimized formulation. We are leveraging our science and engineering expertise to design and develop more effective drug products based on such an optimised formulation approach for poorly bioavailable compounds. Through our extensive range of bioavailability enhancement technologies – including lipid-based formulations delivered via liquid-filled hard capsules and soft gels, solid amorphous dispersions based on spray-dried dispersion or hot-melt extrusion technology, micronisation, and specialized nanocrystal technologies – we see numerous opportunities to help bring better medicines to market.”
Continuous manufacturing
In 2015 the European Consortium on Continuous Pharmaceutical Manufacturing (ECCPM), looked at issues surrounding continuous processing. It discussed how the FDA has endorsed the transition towards continuous manufacturing (CM) as a way to shorten the supply chain, increase agility and flexibility of development and manufacturing and to improve product quality through real time process control.
Dale Natoli, president Natoli Engineering Company is aware of the significance that continuous manufacturing has and will have on the market.
“Continuous manufacturing will continue to be explored and slowly implemented by the pharmaceutical industry. Significant advances in understanding the rheological and size properties of powders and the impact on solid oral dosage forms that these properties impart to the quality of a drug product has helped advance the likelihood of adoption. The interaction of tablet compression tooling with the powder can be a critical dimension of the manufacturing process. Punches and dies can be designed to complement the formulation’s properties, thereby providing trouble-free manufacturing and improving tablet quality,” says the company.
Quality
Alex Bunting, I Holland marketing, recognises the continuing importance of quality in the pharmaceutical sector and the company’s reaction to this.
“With the pharmaceutical industry continuing to grow and flourish, our focus for 2016 is to keep delivering the highest quality tooling and technical service to our customers.
We are celebrating our 70th anniversary this year and during the past seven decades I Holland has worked hard to become leaders in tableting science and provide customers with the best in technical support through a number of methods including new innovations and solutions to tackle common tabletting problems. We will continue to do this through investment in Research and Development which will help the pharmaceutical industry’s requirement for tablet production to be fast, efficient and fault free.”