Pharmaceutical Technology Editors

As reported on June 2, 2021, eight companies representing the pharmaceutical supply chain have joined a newly founded non-profit membership association, Alliance to Zero, which is aimed at facilitating the transition of the pharma sector to comply with net-zero emissions in line with the Paris Climate Agreement.

The founding members of the alliance include Sharp, Harro Höfliger, Schreiner MediPharm, Körber Pharma, Schott, Health Beacon, Datwyler, and Ypsomed, which represent key parts of the pharma supply chain. All members share the view that collaboration across the pharmaceutical supply chain is needed urgently to reduce the manufacturing emissions footprint.

“The formation of this alliance is the first step in a challenging but urgent journey that our member organizations have committed themselves to,” said Sebastian Gerner, president of the Alliance to Zero, in the press release. “Enabling the launch of net-zero pharmaceutical products in regulated markets will require companies like ours to transform our operations, products, services, logistics, innovations, and investments. Our combined effort and our shared responsibility to ensure a real and lasting change is at the heart of the Alliance’s mission.”

A roadmap describing what a net-zero emission concept for pharmaceutical manufacturing and supply chain might look like is already being developed by the alliance. This roadmap will also lay out the steps that are necessary for the industry to achieve the goal of net-zero emissions.

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Eight companies representing the pharmaceutical supply chain have joined a newly founded non-profit membership association, Alliance to Zero, aimed at facilitating the transition of the pharma sector to comply with net-zero emissions.

Eight Pharma Companies Join Non-Profit Association Aimed at Achieving Net Zero Emissions

The Optima Group has announced its investment into expanded production capacities in Germany to meet with high demand for packaging and filling solutions. The company revealed the expansion details in a May 28, 2021 press release.

Among the plans are new state-of-the-art assembly areas for pharmaceutical filling and freeze-drying systems, which will be built in Mornhausen (Marburg district) and in Schwaebisch Hall, the company’s headquarters. Both locations will see capacity expansions to allow for further growth and improved ability to meet increased demand.

At Schwaebisch Hall, the company is building another Comprehensive Scientific Process Engineering (CSPE) center, which will be 25% larger than the current CSPE located at the site. The new center is expected to be completed toward the end of 2021 and will provide Optima customers with expedited processes from product development to market launch.

The expanded capacity at Mornshausen will see 11,000 ft2 of space being added to the multi-story assembly hall, within which freeze-drying systems are manufactured. “This investment will enable us to further increase our production and thus create the best conditions for further growth at the Gladenbach-Mornshausen site,” said Stephan Reuter, managing director, Optima Group, in the press release.

The Optima Group is expanding production capacities in Germany to meet with high demand for packaging and filling solutions. 



Optima Expands Production Capacities to Meet Demand

Advanz Pharma has announced, in a June 1, 2021 press release, that its acquisition by Nordic Capital—a subsidiary of Nordic Fund X Epsilon, Cidron Aida Bidco Limited—has now completed. The deal was struck for $846 million.

“This deal is fantastic news for Advanz Pharma and our goal of becoming the go-to partner for complex medicines in Europe. Nordic Capital will be pivotal in helping the business through both its deep sector expertise and access to capital that will enable considerable investment in our organic and inorganic pipeline. This partnership will be essential in allowing us to further broaden choice for both prescribers and patients throughout the world and ensure access to the essential medicines we supply,” said Graeme Duncan, CEO of Advanz Pharma, in the press release. “This deal could not have been possible without our employees whose hard work has been instrumental in collectively contributing towards building Advanz Pharma into the strong and diverse company it is today.”

Raj Shah, partner and head of Healthcare, Nordic Capital Advisors, added, in the press release, “Advanz Pharma’s vision and regional focus fully aligns with Nordic Capital’s expertise and deep knowledge of European market sectors. We are delighted to be able to support Advanz Pharma at this exciting juncture in their journey. Nordic Capital will help fuel the company’s strategic growth and allow it to invest in future pipeline and M&A activities so that even more patients can access critical medicines now and in the future.”

The acquisition of Advanz Pharma by Nordic Capital has now completed, in a deal worth $846 million.

Nordic Capital Acquires Advanz Pharma for $846 Million

According to a June 2, 2021 press release, Samsung Biologics and KAHR Medical have signed a strategic development and manufacturing agreement for a cancer immunotherapy drug candidate.

As per the terms of the agreement, Samsung Biologics—a contract development and manufacturing organization (CDMO)—will provide end-to-end cell line development and clinical drug substance and drug product manufacturing services for KAHR’s—a cancer immunotherapy company—drug candidate, DSP502. Additionally, Samsung Biologics will provide support to KAHR for its investigational new drug (IND) filing.

“We are proud to announce our partnership with KAHR Medical for the production of their novel drug candidate,” said John Rim, CEO of Samsung Biologics, in the press release. “We will leverage our fully integrated, scalable, and high-quality development services and experienced teams to enable a faster transition from gene to IND in order to ensure KAHR’s success in bringing cutting edge immuno-recruitment cancer drugs to patients in need.”

“We are very pleased to partner with Samsung Biologics, which is recognized as a leader in biopharmaceutical process development and manufacturing,” added Yaron Pereg, PhD, CEO of KAHR, in the press release. “DSP502 focuses on promising checkpoint pathways, unleashing the potential of the immune system to enhance anti-tumor immunoactivity through dual checkpoint inhibition.”

Samsung Biologics and KAHR Medical have signed a strategic development and manufacturing agreement for a cancer immunotherapy drug candidate.

Samsung Biologics, KAHR Medical Sign Strategic Agreement for Cancer Immunotherapy Drug

Celltrion Healthcare, a global biopharmaceutical company, has revealed positive one-year results from a Phase III trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma (CT-P17), with the reference adalimumab in patients with rheumatoid arthritis (RA).

In a June 2, 2021 press release, the company announced that both primary and secondary endpoints of the trial had been met, which demonstrates that Yuflyma has comparative efficacy, pharmacokinetics (PK), safety, and immunogenicity to the reference adalimumab in the treatment of patients with moderate-to-severe active RA up to one year. The randomized, double-blind, Phase III trial included 648 patients and an abstract has been published in an official supplement to the 

Professor Jonathan Kay of the University of Massachusetts Medical School and principal investigator of the trial said, in the press release, “CT-P17 is administered at 100 mg/mL, reflecting the high-concentration formulation of reference adalimumab, and is also citrate-free, which could lessen discomfort during injection. Demonstration of equivalent efficacy and comparable safety of CT-P17 to [European Union] EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar.”

Furthermore, Celltrion has announced that the European Commission (EC) has granted marketing authorization for Remsima SC (infliximab), which is to be used without intravenous infusion in both new and existing RA patients.

“Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima SC to bring clinical benefit for chronic diseases which require long-term treatment,” added HoUng Kim, PhD, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “Having both Remsima SC and Yuflyma in our product pipeline furthers our efforts to deliver value-added medicines to both payers and patients.”

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

Celltrion Reveals Positive Clinical Trial Data for Biosimilar Adalimumab

Cytiva has acquired the German scientific software maker GoSilico, the company announced in a June 2, 2021 press release. GoSilico’s simulation software is used to build digital twins of downstream processing to speed process development using mechanistic modelling to replace physical experiments.

“The powerfully innovative digital solution created by GoSilico will bring great value to our customers, who can use mechanistic models to improve their decisions, accelerate their process development, and more quickly bring new therapies to market,” said Olivier Loeillot, vice-president, Cytiva, in the press release.

“Our entire team is excited to join the Cytiva family. With Cytiva’s global presence and broad base of customers, our mechanistic modelling technology will reach more drugmakers, ultimately enabling a more robust process development and a more efficient path to bring new therapies to patients,” said Thiemo Huuk, co-founder and co-CEO of GoSilico, in the press release.

Traditional process development methods are time consuming. “One factor at a time” can take approximately 13 weeks and design of experiments often takes approximately four weeks, but simulation using modelling in digital twins can be a scalable and robust solution within about one week, Cytiva said in the press release. In addition, modeling reduces the amount of experiment materials used.

GoSilico’s products will continue to be known as GoSilico ChromX and GoSilico DSPX for the immediate future and will be integrated into Cytiva immediately, according to the press release.

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.