Pharmaceutical Technology Editors

Miele Professional, a provider of commercial and industrial appliances, including lab equipment, has earned the Accountability, Consistency, and Transparency (ACT) Label from My Green Lab, a non-profit organization that supports sustainability in science, for three Miele glassware washer machines—the PG 8583, the PG 8593, and the PG 8583 CD. The ACT Label represents the standard for lab sustainability, and this achievement makes Miele the only glassware washer manufacturer to have achieved the certification, Miele announced in a June 2, 2021 press release.

The ACT label shows how products “rate” in sustainability-related categories. The Environmental Impact Factor is a sum of verified information on a product's energy consumption, water use, and end-of-life. The three Miele glassware washers received the following Environmental Impact Factors:

Miele PG 8583 glassware washer—Environmental Impact Factor of 72.5

Miele PG 8593 glassware washer—Environmental Impact Factor of 76.6

Miele PG 8583 CD glassware washer—Environmental Impact Factor of 74.5.

Miele’s PG 8583 glassware washer already achieved ACT Label certification in 2019, and following My Green Lab’s rigorous testing process, the model was recertified, along with the first-time certification of the PG 8593 and PG 8583 CD. Certifications will be valid for one calendar year.

Miele PG 8583, PG 8593 and PG 8583 CD Laboratory Glassware Washers offer the following benefits:

Deionized water connection, liquid dispensing

Optimized cleaning performance and efficient use of resources—variable speed pump with integrated heating elements

Safety through monitoring—wash pressure and spray-arm monitoring

Convenient drying—EcoDry or DryPlus with high-efficiency particulate air filter.

“Sustainability is at the core of everything we do at Miele. We continuously strive to be a global leader in environmental protection within our industry and are committed to our promise to conserve valuable resources, save energy, and reduce emissions,” said Marion Anacker, head of Sales, Lab—Medical—Dental, Miele Professional USA, in the company press release. “We believe there is a great opportunity to continue to reduce the environmental impact of labs across the country through smarter equipment, and My Green Lab’s eco-nutrition label is making sustainable purchasing decisions easier every day. We applaud this initiative and are incredibly proud that three of our machines have earned ACT Label certification.”

“By certifying their glassware washers through our ACT Label program, Miele is helping set the standard for sustainable laboratory equipment. The label supports their customers to make more informed purchasing decisions, leveraging a trusted third-party system,” said James Connelly, My Green Lab’s CEO, in the press release. “Ultimately, this helps save water [and] energy and reduce[s] the environmental impact of a critical, but often resource intensive, industry.”

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The three Miele washer machines have been officially certified with the “eco-nutrition” label by My Green Lab. 

Miele Earns ACT Label Certification for Three Glassware Washers

The new Waters SELECT SERIES multi reflecting time-of-flight (MRT) mass spectrometry platform, launched in June 2021, offers high-quality resolution at fast speeds. The instrument combines MRT technology with both enhanced desorption electrospray ionization (DESI) and new matrix-assisted laser desorption ionization (MALDI) imaging sources.

Together, these technologies enable scientists to more precisely explore molecular structure and function with a unique combination of speed, resolution, and mass accuracy. A scientist can research how an investigational oncology drug interacts with its intended target, such as a specific brain tumor receptor, for example, and can now do so at much faster speeds, up to 10 Hz, without compromising mass accuracy or resolution, Waters stated in a June 8, 2021 press release.

DESI is a direct-from-sample, soft ionization technique performed under ambient environmental conditions, requiring no prior sample preparation. This technology provides imaging information about the biochemical distribution of small-molecule drugs, lipids, and naturally occurring metabolites within a slice of tissue or on other sample surfaces after a single measurement. Scientists today are applying DESI to research breast and ovarian cancer, to study drug metabolism and pharmacokinetics (DMPK), to investigate the function of key metabolites in natural products in traditional medicines, and to get a closer look at the biotransformation of bacterial colonies after gene modifications.

The advanced DESI XS features a new high-performance sprayer and a heated transfer line source. It delivers new levels of usability, image clarity and sensitivity at high speed, bringing more accessible imaging to scientists through mass spectrometry data.

The SELECT SERIES MRT is available with a newly designed MALDI source, making it usefule for scientists interested in conducting MALDI imaging experiments, MALDI is an ideal complementary technique for the imaging of biological molecules, such as peptides, and can visualize tissue sections at spatial resolutions of less than 10 microns. Taken together, the combination of imaging sources gives researchers the means to generate fine spatial information and morphological detail for biological samples and even visualize brain vasculature.

The SELECT SERIES MRT platform forms the basis of next-generation Waters high-resolution mass spectrometers. This product is the first commercially available instrument of its kind that is capable of attaining 200,000 full width half maximum (FWHM) resolution and part-per-billion mass accuracy, independent of scan speed, according to Waters. The instrument allows scientists to get the highest quality mass spectrometry data and information at faster times than other commercial mass spectrometers on the market today, the company stated in its press release. The new MRT technology features an extended flight path of almost 50 meters to give scientists a clearer picture of structural information, including fine isotope structure.

“The Waters SELECT SERIES MRT opens the door to a greater understanding of molecules and their mechanisms of action in numerous scientific fields,” said Dr. Udit Batra, CEO and president, Waters. “The clarity of images produced by this instrument can yield profoundly important molecular information to scientists in research areas such as targeted therapeutics, to provide insights and enable deep biological discoveries.”

The new multi reflecting time-of-flight mass spectrometry platform from Waters delivers highest quality resolution at fast speeds.

Waters’ New SELECT SERIES MRT Mass Spec Platform Delivers Speedy High-Quality Resolution

It was announced in a June 28, 2021 press release, that the Council of Europe has appointed Petra Dörr, PhD, as the future director of the European Directorate for the Quality of Medicines and Healthcare (EDQM).

In October 2021, Dörr will take over the role from Susanne Keitel and will bring with her over 25 years of international experience in the pharmaceutical industry—both private and public sectors. Currently, Dörr is the head of Unit Regulation and Prequalification Department, Access to Medicines and Health Products Division at the World Health Organization (WHO). In this role, Dörr heads up teams dealing with facilitated product introduction, incidents and substandard or falsified medical products, laboratory services and networks, pharmacovigilance, regulatory convergence and networks, and regulatory system strengthening.

Early on in her career, after training as a pharmacist, Dörr worked in the medical products industry for a decade in international regulatory affairs. In October 2004, Dörr joined Swissmedic as the head of International Affairs and in July 2007 was promoted to head of Management Services and Networking, and became a member of the management board. Between January 2014 and June 2019, Dörr was the head of Communication and Networking and deputy executive director of Swissmedic.

Additionally, Dörr served as the chair of the International Pharmaceutical Regulators Forum (IPRF)—now known as the International Pharmaceutical Regulators Programme (IPRP)—from 2013 until 2016. She was elected as the vice-chair of the International Council for Harmonisation (ICH) Assembly in November 2018 and has been a member of the ICH Management Committee, the IPRP Management Committee, and represented Swissmedic at the Heads of Agencies Summits/International Coalition of Medicines Regulatory Authorities meetings.

The Council of Europe has appointed Petra Dörr, PhD, as the future director of the European Directorate for the Quality of Medicines and Healthcare (EDQM).

The Council of Europe Appoints Petra Dörr as Future EDQM Director

Contract development and manufacturing organization (CDMO) Genezen Laboratories has broken ground on a new current good manufacturing practice (CGMP)-compliant lentiviral vector production facility.

According to a June 24, 2021 press release, the first phase of the build will incorporate the construction of a 25,000-ft

 site that will include a process development lab expansion. Completion of the first phase is anticipated in Autumn 2021 with the remaining build out expected to be completed early on in 2022. The new facility is being funded by a majority investment from Ampersand Capital Partners.

“The cell and gene therapy sector is evolving rapidly, and there’s growing demand for capacity and expertise. Building on recognized expertise in lentiviral and retroviral vector platforms, and leveraging the CDMO experience of our investor Ampersand, we are investing heavily to meet this need now, and in the future,” said Bill Vincent, chairman and CEO of Genezen, in the press release. “Our new facility will support clients with the latest technologies as they develop and deliver life-changing therapeutics to patients.”

“I am confident that our partnership will help Genezen to better serve its customers as the company builds out its infrastructure and service offering, to complement the deep expertise of its people,” added David Anderson, general partner at Ampersand, in the press release. “We believe that Genezen will fast become a market leader in CGMP manufacturing of lentiviral vectors for the cell and gene therapy sector—it’s an incredibly exciting prospect in a revolutionary healthcare market that is set to grow for years to come.”

Genezen Laboratories has broken ground on a new current good manufacturing practice (CGMP)-compliant lentiviral vector production facility.

Genezen Invests in New CGMP Lentiviral Vector Production Facility

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of adult patients with moderate to severe plaque psoriasis.

Bimekizumab is an investigational IL-17A and IL-17F inhibitor that has been found to be effective and safe in adults with moderate to severe plaque psoriasis in three Phase II studies. The positive opinion of CHMP was supported by the positive Phase III trial results.

“This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe,” said Emmanuel Caeymaex, executive vice-president, Immunology Solutions and head of US, UCB, in a June 25, 2021 press release. “We’re delighted by today’s decision which recognizes the strength of the psoriasis clinical development program. Bimekizumab is testament to our commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes.”

CHMP’s positive opinion will be shared with the European Commission, which will decide upon the marketing authorization for the European Union member states and the European Economic Area countries. The commission’s decision is expected to be delivered in two months.

EMA's CHMP has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of plaque psoriasis.

CHMP Recommends EU Approval of Bimekizumab for Plaque Psoriasis

Otsuka Pharmaceuticals Europe, a subsidiary of Otsuka Pharmaceuticals Co., Ltd., has filed an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for voclosporin—an investigational, oral calcineurin inhibitor.

According to a June 25, 2021 press release, the European MAA has been submitted for voclosporin to be used as a treatment of lupus nephritis (LN), a complication of the autoimmune disease systemic lupus erythematosus (SLE). The drug is administered orally and works by inhibiting calcineurin, an enzyme that is important for the proliferation and activation of T-cells.

In December 2020, Aurinia Pharmaceuticals and Otsuka Pharmaceuticals entered a collaboration and license agreement for the development and commercialization of oral voclosporin as a treatment for LN in the European Union, Japan, United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. FDA has also approved, in January 2021, voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adults with active LN.

Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.