Complex biotherapeutics present unique analytical challenges for developers.

Complex Biomolecules Require Analytical Evolution

EMA starts review of Sanofi vaccine; Regeneron's EUA expanded

Emergent BioSolutions Gets FDA OK to Resume Operations

Public-private consortium is tasked with advancing domestic pharmaceutical production.

HHS Strategizes for Domestic Drug Supply

New biotherapeutics both drive and benefit from innovative development technologies.

Innovation Demands and Spurs Invention

A clinical trial, conducted by BMG Pharma (a biopharmaceutical and B2B company), has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients, the company reported in a Aug. 2, 2021 press release.

The study, which included a total of 106 people, showed sufficient efficiency of the treatment with the nasal spray and mouth rinse versus placebo in preventing COVID-19—determined with a PCR test. The efficacy of the products is believed to be a result of the combined action of hydrogen peroxide and hyaluronic acid, which form protective barriers in the nasal mucosa and oral mucosa.

Based on the results, the company have suggested that the investigated active intervention may be effective at increasing the rate of negativization of a positive PCR swab test for SARS-CoV-2. However, further research is required to confirm the initial results in certain population subgroups.

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BMG Pharma's clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.

Nasal Spray and Mouth Rinse Demonstrate Efficiency in Preventing COVID-19 and Other Infections

Evonik has reported, in an Aug. 2, 2021 press release, that it has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio for new medical device markets. The JeNaCell employees will continue to work at the development and production site based in Jena, Germany.

“JeNaCell has developed one of the most innovative biomaterials for medical device technologies. With the help of the creativity and expertise of JeNaCell's specialists, we will ensure that even more patients benefit from these products in the future,” said Thomas Riermeier, head of Evonik’s Health Care business line, in the press release. “The acquisition will help us to further strengthen our position as an innovation hub for the world’s leading medical technology companies.”

“The acquisition by Evonik is a quantum leap for JeNaCell to realize the full potential of our innovative technology,” added Dana Kralisch, CEO and co-founder of JeNaCell, in the press release. “We are excited to have found a strong and trusted partner to develop our technology platform and a new home for our passionate team of experts. Together, we will expand our customer base and explore new application areas.”

“JeNaCell is a great example for the innovation strength and the value that startups can bring to corporations,” said Bernhard Mohr, head of Evonik Venture Capital, in the press release. “We recognized the importance of the industry shift to nature-identical materials early on and are very happy to have supported the development of this technology with our investment.”

Evonik has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio.

Evonik Expands Biomaterials Portfolio through JeNaCell Acquisition

Nanoparticle medicine enabling company, Nanoform, and research-driven pharma company, Boehringer Ingelheim, have executed a master services agreement in relation to pre-clinical development projects.

Through the agreement, which was announced in an Aug. 3, 2021 press release, the companies will work together to try and solve the growing challenge of poor bioavailability and solubility in new drug candidates. As per the partnership, Boehringer Ingelheim will be able to perform proof of concept studies to assess the added value of Nanoform’s Controlled Expansion of Supercritical Solutions (CESS) technology to drug development projects.

“Wider uptake of the latest technological innovations is essential to address the low success rates for new drug candidates in Pharma,” said Christian Jones, CCO of Nanoform, in the press release. “We are delighted to collaborate with Boehringer Ingelheim to evaluate how our proprietary CESS platform can help more novel therapies reach the patients who need them. This is the first step toward what we hope will be a long and fruitful partnership between our companies.”

Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.

Nanoform, Boehringer Ingelheim Collaborate on Pre-Clinical Development Projects

Imugene Ltd, a clinical stage immuno-oncology company and Celularity Inc., a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, have entered into a research collaboration to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CyCART-19, for the treatment of solid tumors, according to an Aug. 5, 2021, announcement from the companies.

Imugene exclusively licensed the CD19 oncolytic virus technology from the California-based City of Hope cancer research and treatment center. Imugene’s strategy to treat solid tumors uses an oncolytic virus to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, that can then be used as a target for CAR T cellular therapy, the company reports.

CyCART-19 is a placental-derived T-cell investigational therapy engineered with a CAR that is cryopreserved and will be available off-the-shelf, the company reports. The therapy is in development initially for the treatment of B-cell malignancies, targeting the CD19 receptor. The company plans to file an investigational new drug application in the fourth quarter of 2021 and begin Phase I trials in the first quarter of 2022.

“We believe the synergy between Celularity’s placental derived cells and our OnCARlytic platform has the potential to shift the cellular medicine paradigm,” said Leslie Chong, managing director and chief executive officer of Imugene in a press statement. “In preclinical studies Celularity’s cellular therapies have shown the ability to overcome limitations that have hindered other approaches, including increased proliferation and persistence 

, resistance to T-cell exhaustion and low immunogenicity, which allows for repeated dosing. These unique characteristics perfectly align with our vision for a combination treatment strategy, and we look forward to closely working together to bring this treatment strategy to the clinic and patients in need.”

Robert J. Hariri, MD, PhD, founder, chairperson and chief executive officer of Celularity, also noted in the press statement, “We are excited to initiate this research collaboration, which we believe will lay the foundation for a new approach to the treatment of solid tumors. Most solid tumors have variable targetable antigens, limiting CAR T-cell therapy efficacy. This treatment strategy with Imugene has the potential to apply to a new range of indications by enabling CD19 targeted cellular medicine to expand from its current effective usage in CD19 positive lymphomas and leukemia and potentially become applicable to a variety of solid tumors through inducing uniform expression of CD19 in solid tumors.”

The companies report research showed mice being cured of cancer with the CF33-CD19 and CAR T-cell combination. The first clinical trial, planned for 2022, will evaluate the safety and efficacy of CF33-CD19 in combination with CAR T therapy in patients with solid tumors.

A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.

Imugene and Celularity to Develop Solid Tumor Treatment

The European Commission (EC) has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

Notification of the entry into the Clinical Trial Regulation was published in a notice in the 

, confirming that the clinical trial European Union (EU) Portal and Database have reached full functionality.As reported in an Aug. 2, 2021 press release from the European Medicines Agency (EMA), both the application of the regulation and the go-live of the CTIS are set to take place six months after the publication of the notice.

CTIS will become the single point of entry for any clinical trial application submission, authorization, and supervision within the EU and the European Economic Area (EEA). With the new system, clinical trial sponsors will be able to apply for clinical trial authorization in up to 30 EEA countries with a single application, EMA specified in the press release.

Additionally, the CTIS, in conjunction with other EMA IT tools, will support the coordinated assessment of clinical trial safety reporting and will facilitate recruitment of trial participants by allowing sponsors and researchers to expand trials to other EEA countries.

It is hoped that the CTIS will foster better transparency and collaboration across borders within the EU and EEA countries. The CTIS will comprise a public website, which will host detailed information on clinical trials and the outcomes of the clinical trials that are conducted in the EU.

More information on the regulation and new system can be found on EMA’s website.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022. 

EC Confirms Go-Live Date for Clinical Trials Information System

According to a Aug. 3, 2021 press release, WuXi STA—a subsidiary of WuXi AppTec—has finalized its acquisition of Bristol Myers Squibb’s (BMS’) drug product manufacturing facility based in Couvet, Switzerland.

Plans for the acquisition were announced earlier in 2021, and with the successful completion, the newly acquired site is the first in Europe for WuXi STA. The Swiss facility expands WuXi STA’s capacity on a global scale and will afford the company greater access to the European market.

“We are delighted to have added the Couvet site to our global supply network and are excited to welcome its highly skilled team to the WuXi STA family,” said Minzhang Chen, Co-CEO of WuXi AppTec, in the press release. “Through combining resources of the Couvet site with our other facilities, we continue strengthening and broadening our capacity and capabilities to better support our global customers in delivering innovative medicines to patients in need.”

WuXi STA has finalized its acquisition of Bristol Myers Squibb’s drug product manufacturing facility based in Couvet, Switzerland.

WuXi STA Finalizes Acquisition of BMS’ Swiss Manufacturing Facility

Bristol Myers Squibb (BMS) has been granted approval by the European Commission (EC) for Opdivo (nivolumab) as an adjuvant treatment for adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy (CRT).

EC’s decision was based upon the results of a Phase III clinical trial (CheckMate – 577), which demonstrated the efficacy and safety of the therapy. In the randomized, multicenter, double-blind trial, the patients that received Opdivo were found to have doubled disease-free survival rates compared with those patients who had been administered a placebo treatment.

“We have demonstrated that the use of immunotherapy in earlier stages of cancer has the potential to prevent recurrence for certain patients,” said Ian M. Waxman, MD, development lead, gastrointestinal cancers, Bristol Myers Squibb, in a July 30, 2021 company press release. “BMS was the first company to bring checkpoint inhibitors into the adjuvant setting for the treatment of patients with melanoma, and we are pleased to be the first to bring adjuvant therapy to patients in the EU with esophageal or gastroesophageal junction cancers who continue to face a high unmet need.”

Opdivo also was granted approval from the US FDA in May 2021.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

BMS Gains European Approval for Opdivo

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine (Spikevax) active substance in its United States manufacturing site.

CHMP’s decision is expected to impact the supply of Spikevax within the European Union (EU) as it is estimated that the US supply chain will provide 40 million doses of Spikevax for the EU in the third quarter of 2021. Furthermore, the recommendation reaffirms that the two US facilities—ModernaTX in Norwood, Mass., and Lonza Biologics in Portsmouth, NH—that were recently approved are able to produce high-quality active substances consistently.

So far, CHMP has authorized four manufacturing sites for the production of the active substance for Spikevax. Two sites in the US, as mentioned earlier, and two sites located in Visp, Switzerland.

CHMP’s recommendation on this matter does not require any further decision from the European Commission.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.



CHMP Approves Manufacturing Scale-Up for Spikevax

Bioiberica, a global life sciences company, has received certification of its corporate social responsibility (CSR) management system as being aligned with the United Nations (UN) Sustainable Development Goals (SDGs), the company revealed in a July 27, 2021 press release.

The certification was awarded to Bioiberica after an audit process by Bureau Veritas, which highlighted strong alignment of the company’s CSR with 6 out of the 17 SDGs defined by the UN. As a result, Bioiberica has become the first Spanish pharmaceutical company to be awarded such a certification and has reaffirmed its position as committed to environmental, social, and economic sustainability.

“Bioiberica is firmly committed to sustainability and the circular economy model,” said Luis Solera, Bioiberica’s CEO, in the press release. “With this comes the responsibility of constantly working to improve the health of people, animals, and plants, and promoting a coherent ecological transition that contributes to creating a healthier planet. The recognition of the CSR management system reinforces our determination to continue working towards a better future.”

“By achieving certification of its CSR Management System aligned with the SDGs, Bioiberica takes a further step in its crucial commitment to sustainability,” added Bertrand Martin, executive president of Bureau Veritas Spain and Portugal, in the press release. “We’re very proud to have certified a company whose commitment is to improve global health and wellbeing, and working with companies like Bioiberica reinforces our desire to contribute to a more responsible economy.”

Bioiberica has received certification of its CSR management system as aligned with the United Nations Sustainable Development Goals.

Bioiberica Obtains CSR Management System Certification Aligned with UN Sustainable Development Goals

The University of Sheffield, in collaboration with the Cell and Gene Therapy Catapult (CGT Catapult), has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

LifeArc and the Motor Neurone Disease Association have awarded £513,141 (US$715,902) to the research so that the gene program can be tested for feasibility and efficiency to treat motor neurone disease (MND) and frontotemporal dementia (FTD) patients with underlying mutations in a causative gene known as C9orf72.

The research is being led by Guillaume Hautbergue, head of the RNA Biology Laboratory, in collaboration with Mimoun Azzouz and Dame Pamela Shaw, all from the University of Sheffield’s Institute for Translational Neuroscience. Additionally, the work will be conducted in collaboration with the CGT Catapult, which will provide a detailed non-clinical safety strategy and regulatory advice to guide the team from the University of Sheffield for the potential commercialization of an advanced therapy medicinal product.

“This is a completely new approach to tackling the most common type of [MND],” said Hautbergue, in a July 29, 2021 press release. “No one has yet attempted to prevent these repeated sequences of RNA from leaving the cell’s nucleus and it opens up new areas of investigation for gene therapy. It is an exciting time for biomedical research and the development of novel treatments for incurable diseases such as MND.”

“The progress of this scientific breakthrough from the University of Sheffield and the support for this program by leading investors and charities such as LifeArc and the MND Association, is testament to the UK research excellence and favorable ecosystem for cell and gene therapies,” commented Matthew Durdy, CEO, CGT Catapult, in the press release. “We welcome the opportunity to be part of this program and look forward to working with the University of Sheffield to help advance their innovative gene therapy technology into the clinics.”

The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

Featured Content

Complex Biomolecules Require Analytical Evolution

Emergent BioSolutions Gets FDA OK to Resume Operations

HHS Strategizes for Domestic Drug Supply

Innovation Demands and Spurs Invention