Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Patrick Lavery

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In a press release on Jan. 7, 2025, Phillips Medisize’s parent company, Molex, announced the completion of Phillips Medisize’s acquisition of Vectura Group from Vectura Fertin Pharma, of Chippenham, United Kingdom, a subsidiary of Philip Morris International (1). Phillips Medisize, a global contract development and manufacturing organization which designs and makes products for the pharmaceutical drug delivery, 

 diagnostic, and medtech markets, now adds Vectura’s inhalation capabilities to its stable of services.

The announcement closes a transaction which had previously been disclosed by the two sides involved in September 2024 (2). At that time, the parties expected the deal to close by the end of 2024, meaning official confirmation comes just a week past that deadline.

“The Vectura team is delighted with the completion of the acquisition,” said Geraldine Venthoye, PhD, the chief scientific officer of Vectura Fertin Pharma who has now been appointed to the same post, as well as vice president, for the Phillips Medisize Medical business (1). “We are excited about the opportunities and scale of Phillips Medisize, which will allow us to deliver our formulation and combination product expertise to more pharmaceutical customers as part of end-to-end pharmaceutical development.”

“The acquisition of Vectura reflects our commitment to advancing industry-leading medical capabilities for our customers,” said Molex CEO Joe Nelligan in the January 7 press release (1). “Together Phillips Medisize and Vectura will unlock significant growth potential to support the growing need for inhalation therapies.”

Phillips Medisize itself had previously been acquired by Molex, whose headquarters are in Lisle, Ill., in 2016 (1). The company said in the press release that adding Vectura’s services would enhance its capacity for pharmaceutical R&D.

Vectura’s proprietary technology, plus its experience in the field of combination product development, come to Phillips Medisize in the transaction; this includes dry powder inhalers, metered dose inhalers, nasal inhalers, and nebulizers, according to the press release (1). Among Vectura’s other offerings are pharmaceutical analysis, process development, technical transfer, clinical trial supplies, and regulatory services.

“Phillips Medisize will continue to expand the services we offer pharmaceutical companies thanks to the acquisition of Vectura, particularly in inhalation, to help meet growing patient needs,” said Paul Chaffin, president of Phillips Medisize. “Together Phillips Medisize and Vectura are uniquely positioned to collaborate with leading pharmaceutical customers to develop innovative products that address the growing global demand for new therapies to treat chronic respiratory diseases like asthma and COPD [chronic obstructive pulmonary disease], as well as non-respiratory conditions.”

With a workforce of already more than 6000 covering 30 job sites in North America, Europe, and Asia, Phillips Medisize will add approximately 350 employees with the acquisition of Vectura (1). Among those are some 1200 engineers and scientists.

1. Phillips Medisize. Phillips Medisize Expands Its Inhalation Drug Delivery Capabilities. Press Release. Jan. 7, 2025.
2. Phillips Medisize. Molex, A Parent to Phillips Medisize, Announces Agreement to Acquire the Vectura Group Limited, Expanding Its Drug Delivery Capabilities in Inhalation. Press Release. Sept. 17, 2024.

Articles

The transaction, which was first announced in September 2024, expands Phillips Medisize’s inhalation drug delivery capabilities.

Molex, Phillips Medisize Close Acquisition of Vectura Group

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Hapman, a Kalamazoo, Mich., company focused on the design and manufacture of custom bulk material handling equipment, announced in a press release on Oct. 30, 2024 that it would be introducing a new conveyor at Pack Expo 2024, to be held in Chicago from Nov. 3–6, 2024 (1).

After a yearlong, intensive R&D initiative, Hapman said, the conveyor system—emblematic of the company’s nearly eight decades of expertise in tubular drag conveyors—represents Hapman’s first major product launch since 2008 (1). Hapman said the unveiling of the conveyor will serve to fill a gap in the market for material handling operations in the packaging and processing sectors and offers enhanced performance and versatility (1).

The uniqueness of the demands of Hapman’s customers, the company said, requires that the solutions provided to those customers be efficient and customizable, and designed to ease packaging and processing operations. Additional considerations include safety, productivity, user-friendly design, and the minimization of product loss. Further details about the conveyor are being kept “under wraps” by Hapman until the exhibition gets underway, according to the press release (1).

Hapman additionally plans to show its Bulk Bag Unloader, which features heavy-duty, 3” tubing construction offering adjustable heights that accommodate numerous bag sizes, as well as high durability (1). Dust control systems, vibration devices, and optional, 1- or 2-ton hoists and trolleys with certified, load-tested bag adapters are listed as some of the other features.

Other companies are also previewing their exhibits and offerings ahead of the 2024 edition of Pack Expo. Brewerton, NY-based Pacteon Group announced in a press release on Sept. 9, 2024 that it had added Descon Conveyor Systems to its portfolio, and would be displaying a Descon product at one of its booths at the event (2).

And on Sept. 26, 2024, TekniPlex Healthcare, a full-service contract development manufacturing organization for medical materials science, particularly in the minimally invasive and interventional therapy devices space, announced in a press release that it would unveil its strongest-ever reinforced paper for medical device packaging applications as part of its display (3).

 at INTERPHEX 2024, held in New York City in April 2024; that interview can be viewed 

Hapman can be located at Booth #LU-7561 at Pack Expo 2024, where the company plans to roll out the new conveyor system alongside the Bulk Bag Unloader.

1. Hapman. Hapman to Showcase Material Handling Solutions at PACK EXPO 2024. Press Release. Oct. 30, 2024.
2. Pacteon Group. Pacteon Exhibits New Packaging Automation Solutions at Pack Expo International 2024. Press Release. Sept. 9, 2024.
3. TekniPlex Healthcare. At Pack Expo, TekniPlex Healthcare to Debut Its Strongest-ever Reinforced Paper for Medical Device Packaging Applications. Press Release. Sept. 26, 2024.
4. Bigica, A. 

How TekniPlex is Expanding to Support Innovative Solutions in Materials Science.

The system is Hapman’s first major product launch since 2008, following a year of intensive R&D that builds upon the company’s eight decades of tubular drag conveyor expertise.

Hapman to Showcase New Conveyor at Pack Expo 2024

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending Wainzua (eplontersen) for treatment of hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or 2 polyneuropathy (PN) in England and Wales, AstraZeneca announced in a press release on Oct. 29, 2024 (1).

“We are delighted that eligible patients now have access to this treatment for this significant disease which can be delivered in-clinic or in their own home to support more personalized care,” Tom Keith-Roach, president of AstraZeneca in the United Kingdom, said in the press release (1).

This recommendation of Wainzua closely followed that of the Committee for Medicinal Products for Human Use (CHMP) of the European Union for approval by the European Commission, 

announced by AstraZeneca on Oct. 21, 2024

 and 10 months after FDA approved eplontersen under the brand name Wainua for treatment of adults in the United States in December 2023 (2,3).

"ATTR amyloidosis is a serious, rare disease where people experience neuropathy symptoms, such as pain, discomfort, progressive weakness, and loss of sensation in the legs and arms, and mobility difficulties,” Paul Pozzo, chairman of Amyloidosis UK, said in the Oct. 29 press release. “There is no cure for ATTR amyloidosis, but today’s announcement offers an alternative treatment option to support those living with this condition in the UK ATTR community."

As with CHMP’s recommendation, NICE made its decision based on a 66-week Phase III trial (NEURO-TTRansform) (1).

“Eplontersen provides a new, disease-modifying treatment option, and this is positive news for eligible patients with ATTR-PN and the wider amyloidosis community in the UK,” Marianna Fontana, a professor of cardiology and honorary consultant cardiologist of the National Amyloidosis Centre, Division of Medicine, University College London, said in the press release. “Without treatment, ATTR-PN can lead to extreme polyneuropathy, severe disability, and premature death. In the NEURO-TTRansform Phase III clinical trial, eplontersen significantly lowered serum transthyretin concentration, resulting in less neuropathic impairment and an improved quality of life for patients.”

ATTR-PN, according to AstraZeneca, is caused by a mutation in the transthyretin (TTR) gene responsible for TTR production in the liver (1). The mutation causes the TTR protein to misfold, leading to amyloid fibril accumulation, in turn damaging peripheral nerves in the body. AstraZeneca said ATTR-PN is “frequently under-recognized” because its clinical manifestations are frequently heterogeneous and non-specific (1).

Left untreated, the severe polyneuropathy and motor disability that develops within five years of the onset of ATTR-PN can result in death within a decade (1).

1. AstraZeneca. AstraZeneca Secures Accelerated NICE Recommendation for Wainzua (eplontersen) in England and Wales Following MHRA License to Treat Hereditary Transthyretin Amyloidosis in Adult Patients with Stage 1 or 2 Polyneuropathy. Press Release. Oct. 29, 2024.
2. AstraZeneca. Wainzua (eplontersen) Recommended for Approval in the EU by CHMP for the Treatment of Adult Patients with Polyneuropathy Associated with Hereditary Transthyretin-Mediated Amyloidosis. Press Release. Oct. 21, 2024.
3. AstraZeneca. Wainua (eplontersen) Granted First-Ever Regulatory Approval in the US for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis. Press Release. Dec. 21, 2023.

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

AstraZeneca’s Wainzua Gains Another Approval in England and Wales

The Belgium-based contract development and manufacturing organization (CDMO) Ardena announced on Oct. 29, 2024 that it was making a “strategic investment” in two sites in the Netherlands, one of the countries in which the company maintains good manufacturing practice (GMP) facilities, along with Belgium, Spain, and Sweden (1). Ardena said the improvements were being made with an eye toward client demand for cutting-edge services in the field of bioanalytics.

Namely, the expansion of Ardena’s footprint in the Netherlands will include a brand-new bioanalytical laboratory at its Pivot Park facility, located in the city of Oss, as well as added capacity and new, good laboratory practice (GLP) capabilities at its Bioanalytical Center of Excellence in Assen, according to a press release (1). The enhancements in the two locations are meant to complement each other, the company said.

“This expansion allows us to quickly scale our operations, leverage an additional pool of talented professionals, and bring enhanced efficiency and value to our clients, from discovery to late-stage clinical phases,” Jeremie Trochu, Ardena CEO, said in the press release.

Ardena previously expanded its headquarters in Gent, Belgium, in 2018, at which point the company was operating in that country as well as the Netherlands, Sweden, and Latvia (2). At the time, Ardena said it was seeing an increase in organic growth of more than 20% per year, crediting its merger and acquisition strategy. Shifting forward to 2024, that strategy has most recently included the company acquiring an advanced drug product manufacturing facility in the United States from Catalent (1).

There was also, in 2021, the acquisition of Idifarma, a manufacturer of niche and highly potent generic and innovative drugs based in Pamplona, Spain, from Suanfarma (3). Ardena said its offerings are designed to serve clients from small innovators in the biotech realm to large pharma companies across all stages of drug development, and with respect to small molecules, therapeutic peptides and proteins, antibodies and antibody-drug conjugates, nanoparticles, oligonucleotides, messenger RNA (mRNA), and cell and gene therapies (1).

“Together, these investments demonstrate Ardena's focus on growth and innovation, reinforcing our strategy to assist clients navigate through an ever-increasing complex drug development process and bring life-changing therapies to patients worldwide faster,” Trochu said in the Oct. 29 press release.

The Oss laboratory, which Ardena said will be functional by the first quarter of 2025, covers 3000 sq ft for both small and large molecule analytical testing, complete with an automated technology platform, fluorometric detection assays, and liquid chromatography—tandem mass spectrometry (LC–MS/MS) capabilities (1). By contrast, although the Assen facility will also have its LC–MS/MS capacity increased and will add new automation systems, its focus will be more on immunochemistry, flow cytometry, and quantitative polymerase chain reaction platforms, according to Ardena.

1. Ardena. Ardena Expands Bioanalytical Services in Europe. Press Release. Oct. 29, 2024.
2. Ardena. Ardena Cements Growth and Expansion with New HQ. Press Release. Nov. 8, 2018.
3. Ardena. Ardena Acquires Idifarma from Suanfarma. Press Release. Sept. 1, 2021.

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

Ardena Expands Bioanalytical Services in the Netherlands

Dosage forms, in particular oral solid dose, continue to evolve as new technologies enter the market, and as customer tastes and demands change. In this episode of the Drug Solutions podcast, Patrick Lavery, editor for 

®, surveys attendees from the recent CPHI Milan gathering about how fast the market is expanding, how it's evolved in recent years and even decades, and what drugs are most conducive to OSD formulations.

 is vice president, drug product division, 

 Her CPHI interview can be viewed in full 

 is head of global pharmaceutical sciences, 

 His CPHI interview can be viewed in full 

 is head of product implementation, oral solid dose, Recipharm. His CPHI interview can be viewed in full 

 is vice president and chief innovation officer, Colorcon. His CPHI interview can be viewed in full 

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

Drug Solutions Podcast: Dosage Forms: Roundtable on Oral Solid Dosage Trends

AAPS PharmSci 360 2024: Big Data and Variation in Excipient Production

As part of its AAPS PharmSci 360 2024 coverage, 

 spoke with Pauline Janssen, global technical lead and product development manager at DFE Pharma, about her presentation at the conference, “Using Big Data Analysis to Better Characterize Excipient Variability,” delivered on Tuesday, Oct. 22, 2024.

Janssen said there is inevitable variation in all production processes, including excipient production, and big data sets can help—but especially when those analyzing the data are subject matter experts.

“We believe it's important to understand, what is the consistency? Which [data can] you look at [for] specific parameters, for example, inconsistency documents where you can see what is the typical variation that can be expected in a certain parameter?” Janssen said in the interview. “But a challenge when you want to evaluate multiple excipients, maybe multiple parameters, is actually all the potential interrelationships between those parameters. If you want to do a full evaluation of all these parameters and maybe perform a full design of experiments, you would require a huge amount of resources. And actually, this is also one of the key concepts in the QBD [quality by design] approach that allows [us] to identify what is the typical variation and what is the relevant variation in a large data set.”

Click the above video to watch the full interview.

AAPS PharmSci 360 was held from Oct. 20–23, 2024 in Salt Lake City, Utah. Find the rest of our coverage 

, and more information can be found on DFE Pharma's 

Videos

Pauline Janssen of DFE Pharma gave a presentation on the utility of analyzing big data sets to better understand and diagnose variability in the production process.