Pharmaceutical Technology Editors

Societal CDMO announced on May 5, 2022 that it has entered a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe. The agreement establishes Societal CDMO as the exclusive supplier of Ritalin LA capsules for the European market through 2023.

Societal CDMO had served as Novartis’ exclusive global supplier of Ritalin LA and Focalin XR capsules for approximately 20 years, and Novartis has given European rights to Ritalin LA capsules to InfectoPharm. The new agreement will maintain Societal CDMO’s role as the exclusive supplier of Ritalin LA in Europe. The company’s exclusive Manufacturing and Supply Agreement with Novartis remains unchanged for the rest of the world and will continue through 2023.

“Societal has a long history and know-how with Ritalin, dating back to the company’s innovative formulation work that allowed for the creation of an extended-release version of the product. Over the years, we’ve enjoyed an excellent relationship with Novartis while serving as the exclusive global supplier of Ritalin LA capsules,” said David Enloe, CEO of Societal CDMO, in a press release. “We now look forward to delivering the same high-quality supply and manufacturing services to the InfectoPharm team to support the company’s commercial efforts for the product in the European market.”

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Societal CDMO has signed a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA in Europe.

Societal CDMO Signs Manufacturing and Supply Agreement with InfectoPharm 

Lonza and Integral Molecular recently announced a strategic collaboration wherein they will work together to assess the risks of off-target binding of biologic drug candidates. The collaboration aims to provide a better method of assessing immunogenicity, immunotoxicity, and cross-reactivity potential early in a biologic’s development cycle.

According to a press release from April 25, 2022, the companies feel that their respective expertise complement one another in this endeavor. Lonza’s early development services focuses on cell-based assays, which evaluate the activity of biologic therapies upon binding. Integral Molecular, on the other hand, detects off-target binding liabilities via its Membrane Proteome Array platform.

“Early immunogenicity de-risking significantly increases chances of the future success of therapies as they progress through the development pathway,” said Yvette Stallwood, head of early development services, Lonza, in the press release. “Lonza’s 14 years of expertise in 

 immunogenicity and immunotoxicity assessments complements Integral Molecular’s valuable insights into off-target binding using [its] Membrane Proteome Array.”

“We are pleased to offer complementary expertise to Lonza’s cell-based assay experience for preclinical safety profiling of biologics, thereby offering drug developers a more complete evaluation methodology to select the optimal candidate to move forward to IND [investigational new drug] filing.” said Benjamin Doranz, CEO and co-founder, Integral Molecular, in the press release.

Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.

Lonza and Integral Molecular Enter Biotherapeutics De-Risking Collaboration

MilliporeSigma, the US and Canada life science business of Merck KGaA, announced that its ZooMAb recombinant antibodies earned an accountability, consistency, and transparency (ACT) label from My Green Lab, a non-profit focused on promoting sustainability in science. ZooMAb is the first-ever antibody to receive the ACT label designation, according to MilliporeSigma in an April 14, 2022 press release.

According to the press release, the antibodies received the lowest environmental impact factor (EIF) scores in the chemicals and reagents category. MilliporeSigma attributes multiple characteristics of the antibodies to this score:

As recombinant antibodies, they can be shipped in room temperature packaging. Traditional monoclonal antibodies (mAbs) must be shipped in specially insulated, ice-cooled containers, which contribute to high packaging material consumption and transport emissions.

The antibodies weigh 2.5 grams, which allows for more opportunities to eventually ship the product in much smaller packaging. MilliporeSigma estimates that this would prevent the emission of around 175 metric tons of CO2 per year by 2025.

While the antibodies are based on animal cells, like traditional mAbs, the recombinant technology they employ provides a greater, more consistent supply. It also reduces the use of animals in research.

In addition to these factors, the manufacturing facility where the antibodies are produced has implemented energy, water and waste reduction measures, produces renewable energy from a wind farm, and has an environmental management system program that is International Organization for Standardization 14001 certified. The antibodies also do not contain any Red List chemicals, carcinogenic, mutagenic or toxic to reproduction substances, polybutylene terephthalate, or GreenScreen Benchmark-1 chemicals, further contributing favorably to its low EIF score.

“Helping our customers and suppliers to reduce their impact on the environment is a key part of our sustainability strategy,” said Jeffrey Whitford, head of sustainability and social business innovation, MilliporeSigma, in the press release. “By showing how products rate in different categories, such as manufacturing; energy and water use; packaging; and end-of-life, the ACT label gives scientists another data point to help increase their sustainability. We are proud to be part of this program and are thrilled to achieve one of the top ranking EIF scores for our ZooMAb antibodies.”

MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.

MilliporeSigma’s ZooMAb Antibodies Earn ACT Label from My Green Lab

FDA announced on May 5, 2022 that it has limited the emergency use authorization (EUA) of the Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age or older who elect to receive the vaccine because they would otherwise not receive a COVID-19 vaccine.

FDA warrants the EUA limitation to the risk of thrombosis with thrombocytopenia syndrome (TTS) associated with the vaccine. TTS is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. Onset of symptoms have been seen approximately one to two weeks following the administration of the Janssen vaccine.

FDA has determined that, for the specified groups the vaccine is to be limited to, the known and potential benefits of the vaccine outweigh the known and potential risks. The revision of the authorized use of the vaccine is reflected in the Fact Sheet for Healthcare Providers Administering Vaccine, which includes a warning statement summarizing the risk for TTS.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA Limits Use of Janssen COVID-19 Vaccine

Schott, a specialty glass company, has announced the inauguration of its new high-end polymer prefillable syringe manufacturing facility in Mülheim, Germany, in a May 6, 2022 press release. The company has invested millions in the new plant, which is reported to be providing more than 100 jobs for the region.

An R&D center has been included within the company’s investment, which will be used to drive rapid prototyping of new polymer syringe solutions for drug delivery. Additionally, the investment in the plant include a logistics and integrated administrative area, it was revealed in the press release.

“[The facility’s] opening marks a big step in our strategic business expansion,” said Andreas Reisse, executive vice-president of Schott’s Pharma business unit, in the press release. “The new facility in Müllheim aims to play an important role in supplying the global pharma industry with advanced drug delivery solutions made of polymer.”

Schott has announced the inauguration of its new high-end polymer prefillable syringe manufacturing facility in Mülheim, Germany.

Schott Inaugurates New Prefillable Syringe Manufacturing Facility in Germany

Innovative nanoparticle medicine-enabling company, Nanoform Finland, has launched STARMAP Online—a sparse-data artificial intelligence (AI) solution that it is using as a secure online portal for direct use by the company’s current and future partners.

The company, which announced the launch in a May 4, 2022 press release, has been using the product to provide clients with an assessment of whether their molecules are suitably stable for use with the Controlled Expansion of Supercritical Solutions (CESS) nanoparticle engineering. The AI solution is a digital version of the CESS technology, which provides a determination of whether molecules should be nanoformed through 

“STARMAP Online opens up new galaxies of potential, and we are excited to increase access for the pharma community. The technology has a significant potential impact, allowing viable CESS candidates to be rapidly identified. STARMAP Online has the potential to transform the lives of patients by accelerating the development of new therapies, supporting our mission to touch the lives of a billion patients with nanoformed medicines,” said Prof. Edward Hæggström, CEO of Nanoform, in the press release.

Nanoform Finland has launched STARMAP Online—a sparse-data artificial intelligence (AI) solution that it is using as a secure online portal for direct use by the company’s current and future partners.