Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

Biologic drug products are becoming ever more present in the development pipeline, with healthy growth anticipated in the sector over the next few years (1). However, delivery of these complex molecules is not always straight-forward; in particular, when trying to deliver high doses of viscous biological drug products, common delivery devices that patients rely on to be able to self-administer their therapies are not always suitable for use.

The issue of delivering high dose, large volume, highly viscous biologics is what Congruence Medical Solutions, a start-up company incorporated in 2015 and based in the United States, specializes in. To learn more about the company and how it is tackling the issue of delivering viscous biologics in high doses, 

 spoke with CEO and founder, Gautam Shetty, at CPHI Barcelona 2023.

"We are a US-based drug delivery device company that’s engaged in the design, development, and supply of innovative drug delivery devices," revealed Shetty. "We work on addressing the unmet needs, emerging needs, and really hard to solve problems in injectable drug delivery."

The company focuses on three key areas: “microliter dosing; injection of high-dose biologics or viscous formulations; and minimizing drug waste at the point of injection,” Shetty added.

Shetty pointed out that some biologics can have a viscosity greater than 1000 centipoises, but despite this, he stated that most biologics can be addressed so long as it is possible to inject at a viscosity of 100 centipoises or lower. “We have worked on applications, maybe, as high as 1500 centipoises,” he specified.

In terms of their approach to drug delivery problems, Shetty pointed out that Congruence Medical Solutions are not the same as traditional drug delivery suppliers. “We really bring something to the table that traditional suppliers of drug delivery devices don’t,” he said. “We often joke that we work on things that other won’t or cannot do.”

Biologics Market Size, Share, and Trends Analysis Report by Source (Microbial, Mammalian), by Product (mAbs, Recombinant Proteins, Antisense, and RNAi), by Disease Category, by Manufacturing, by Region, and Segment Forecasts, 2023–2030. 

Congruence Medical Solutions was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

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Pharmaceutical Technology Europe® spoke with Gautam Shetty from Congruence Medical Solutions, a US drug delivery device company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Addressing Delivery Needs with Congruence Medical Solutions at CPHI Barcelona

Excipients are a crucial component of a pharmaceutical finished dosage form, normally providing support to help produce an effective drug product. Galvita AG, a start-up company based in Basel, Switzerland, was founded in 2021 and its COO, Dr. Rainer Schmidt, was on hand at CPHI Barcelona 2023 to provide 

with an overview of the company's offerings.

"Galvita is an excipient manufacturer," explained Schmidt. "We are producing excipients as a platform technology to be loaded with active ingredients."

Schmidt highlighted that the company is working with as many active ingredients as possible, looking to load these ingredients into an orally dispersible tablet (ODT) form. "[These ODTs] are taken by the patient [orally] and disintegrate very fast," he said. "The microcapsules [then stick] onto the mucosa and transport the active ingredient to the body."

According to clinical studies performed by Galvita, Schmidt revealed that the onset of the active ingredients has been shown to be around 10 minutes. "So, [our platform is] very fast acting," Schmidt added. "It's a very nice product to [use to] implement emergency medicine, epilepsy medicines, and any medicine you would like to have."

Schmidt went on to highlight the fact that Galvita can also incorporate poorly soluble compounds within its offerings. "The loading capacity is about 30%, and we are using water solutions and ethanol at the moment, but also isopropanol is possible," he added.

Furthermore, ODTs provide a great option for specific patient-populations, such as geriatrics and pediatrics, Schmidt stated. If the patient has difficulty swallowing, then an ODT enables the patient to simply pop the drug product into their mouth and it can dissolve and administer the drug product. "So, because we do not need so much liquid to disintegrate the tablets, in the end you cannot feel [them] in the mouth," he specified.

Taste-masking is also a possibility, Schmidt confirmed, as the microparticles used "suck in the active ingredient" and protect it. So, Galvita's platform can also taste-mask bitter ingredients, which is again beneficial for pediatric patients, he remarked.

It is also possible to coat the tablets—so, they are no longer ODTs—but within this coated format, Schmidt pointed out that it is possible to transport the tablet to the colon of the patient. "In the colon you can also have these mucosa adhering effects," he said. An option particularly useful for diseases within the stomach-colon area.

"The active ingredients we use are only in combination with inorganic materials," Schmidt summarized. "Our microcapsules are pure tri-calcium phosphate, which is [stable in the mouth] as microparticles … so no problem in terms of toxicological effects."

Galvita AG was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023. 

Pharmaceutical Technology Europe® spoke with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Producing Excipients as a Platform Technology with Galvita at CPHI Barcelona

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Global biopharma company, GSK, has entered into an exclusive strategic partnership with Chongqing Zhifei Biological Products Co. (Zhifei)—a fully-integrated biotechnology company—to co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

According to an Oct. 9, 2023 press release, the partnership, which has been set to last for an initial three-year period with the option to extend in the future, will broaden the availability of Shingrix in China significantly. Additionally, the partnership is expected to support future co-development and commercialization in China of GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and older.

The agreement is set to begin on Jan. 1, 2024 and will see Zhifei gain the exclusive rights for the importation and distribution of Shingrix within China, while GSK will co-promote the vaccine in the country through raising awareness of the importance of shingles vaccination for healthcare professionals. Under the terms of the agreement, Zhifei will buy agreed upon volumes of Shingrix that will equate to a total value of £2.5 billion ($3.1 billion) to GSK over the course of three years. The volumes of the vaccine purchased will be phased over time to accommodate the expected increase in demand as the vaccine and its importance are promoted. Further, as a part of the terms of the partnership, Zhifei has given GSK the right of first refusal to be the exclusive partner for a similar arrangement for GSK’s Arexvy vaccine once it has been approved in China.

“This partnership is consistent with our focus on products with a high and durable level of differentiation,” said Luke Miels, chief commercial officer, GSK, in the press release. “It materially expands the number of Chinese adults who can benefit from Shingrix and includes the option to extend the collaboration to include our novel RSV vaccine Arexvy.”

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The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China. 

GSK and Zhifei Partner to Extend the Availability of Shingrix

The Janssen Pharmaceutical Companies of Johnson & Johnson have requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). The submission was announced in an Oct. 6, 2023 company press release.

In the Type II extension request, submitted to the European Medicines Agency (EMA), Janssen is seeking approval for its amivantamab therapy to be used in combination with chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Janssens’ antibody therapy was granted conditional marketing authorization by the European Commission in December 2021 as a monotherapy for adults with NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy has been unsuccessful.

The indication extension application to EMA is supported by the results of a Phase III clinical study (PAPILLON) that has evaluated the efficacy and safety of amivantamab in combination with chemotherapy as a first line treatment for NSCLC patients with EGFR exon 20 insertion mutations. In July 2023, Janssen revealed that the Phase III study met its primary endpoint, demonstrating that the combination of amivantamab with chemotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival for patients when compared with chemotherapy alone.

“People living with advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations generally face a poor survival probability, and new treatment options are urgently needed from the very first line of therapy,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag, in the press release. “Today’s submission to the EMA highlights our deep commitment to change the trajectory of lung cancer, through earlier intervention with targeted treatment options for eligible patients.”

“PAPILLON is the first randomised Phase [III] study to read out in patients with NSCLC with EGFR exon 20 insertion mutations. Pending approval, this creates an opportunity to make a significant improvement to the standard of care for this patient population, where high unmet medical needs remain,” added Kiran Patel, vice president, Clinical Development, Solid Tumors, Janssen Research & Development, in the press release. “We look forward to working with the EMA to bring this potential new indication to the lung cancer community as soon as possible.”

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). 

Janssen Seeks European Approval of Extended Indication for Rybrevant

Orakl Oncology—a precision oncology start-up spun out of the Gustave Roussy Institute in France—has fundraised €3 million (US$3.2 million) to develop its techbio platform, which enables the identification of relevant targets and accelerate delivery of oncology drugs.

Within oncology, a major hurdle to overcome is getting drug candidates to patients sooner in the development process. Currently, the late delivery of drug candidates to cancer patients leads to a 96% failure rate in clinical trials and missed treatment options, the company reported in an Oct. 4, 2023 press release.

Additionally, as each tumor is different, it is important for future cancer treatments to be developed with this uniqueness in mind. Therefore, Orakl Oncology has built unique tumor avatars through the combination of cell biology, engineering, and machine learning that have the capability of mimicking real-life responses to drugs. The company’s collection of avatars, which is growing, will provide a population-scale view of the complexity and heterogeneity of cancer, which will, in turn, help pharma and biotech companies achieve clinical trial success.

“Our ambition is to become a world-leading techbio platform leveraging the smartest collection of tumor avatars to transform oncology drug development and bring faster, smarter, and more cost-effective treatments to patients,” said Dr. Fanny Jaulin, Orakl Oncology CEO and co-founder, in the press release. “We are delighted with the result of this oversubscribed fundraising round, and we are very grateful to all our investors for their support.”

“We are very proud of Gustave-Roussy’s spin-out, Orakl Oncology,” added Prof. Fabrice Barlesi, general director of Gustave Roussy, in the press release. “They [Orakl Oncology] aim to disrupt precision oncology by leveraging major academic and pharma partnerships to accelerate drug development, ultimately leading to better patient outcomes.”

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

Millions Raised for the Development of Precision Oncology Platform

Global contract development and manufacturing organization (CDMO), Cambrex, has doubled its manufacturing capacity with an expansion of its facility in High Point, North Carolina. The completion of the expansion was announced by the company in an Oct. 2, 2023 press release.

The $38 million expansion has added new state-of-the-art analytical and chemical development laboratories, two new clinical manufacturing suites, and a small-scale commercial manufacturing operation comprising three work centers and 2000 L reactors to the High Point facility. Additionally, with the added infrastructure, Cambrex has created more than 70 new positions and is seeking to recruit expert pharmaceutical R&D scientists and staff within the region.

“When we began this project in 2021, our vision extended far beyond capacity,” said Tom Loewald, CEO, Cambrex, in the press release. “We designed a facility that can continue to deliver on client needs as the industry evolves, with state-of-the-art technology and laboratory equipment, an energy-efficient infrastructure, and clinical to commercial manufacturing scale.”

“We are extremely excited about this expansion in North Carolina, which would not have been possible without the support of the State’s leadership and economic development programs, and their focus on nurturing the region’s skilled and diverse workforce,” added Dan Bowles, vice president and general manager, Cambrex High Point, in the press release.

Furthermore, the newly expanded High Point facility provides complementary capabilities to those of Snapdragon Chemistry—which Cambrex had previously acquired in January 2023. Snapdragon Chemistry specializes in R&D for API batch and continuous flow process design, meaning that the combination of those capabilities along with the new offerings available at High Point will provide customers with a single-vendor offering for their flow chemistry scale-up needs through to commercialization.

Cambrex has completed the expansion of its North Carolina facility, doubling its manufacturing capacity.