How have lessons from the pandemic influenced the way companies use technology to perform quality-control procedures?

A New View on Quality Control?

Preclinical and clinical research is improving ADC development.

ADC Development Improves on Research

Strategizing drug development in the preclinical phase has merit.

Preclinical Strategies Benefit Biopharma Development

Perfusion cell culture gains advantage with PAT tools advancement.

Perfusion Cell Culture is Gaining Momentum

Coating is an alternative to silicone oil as a lubricant. URL for article 

Syringe Coating Technology

Redefining Contamination Control for CGTs

Novavax COVID-19 Vaccine Receives EUA in Indonesia

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

REGENXBIO announced the closing of its collaboration and license agreement with AbbVie to develop and commercialize its gene therapy candidate, RGX-314, on Nov. 9, 2021. Under the terms of the agreement, REGENXBIO will receive an upfront payment of $370 million from AbbVie, with an additional $1.38 billion to be paid should additional development, regulatory, and commercial milestones be met.

RGX-314 is a potential one-time gene therapy for treatment of wet-age-related macular degeneration, diabetic retinopathy, and other chronic retinal diseases. According to a company press release, RGX-314 encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). VEGF pathways are believed to result in leaky blood vessels that contribute to the accumulation of fluid in the retina.

Currently, REGENXBIO is researching two separate routes of administration for RGX-314 to the eye. One is through a standardized subretinal delivery procedure, while the other delivers it through suprachoroidal space. The company has licensed exclusive rights to the SCS Microinjector from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

Per the terms of the deal, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314; costs of future trials will be shared across both companies. The companies will equally share any RGX-314 net sales in the United States, whereas AbbVie pay REGENXBIO tiered royalties on net sales of RGX-314 outside the U.S.

Articles

AbbVie will pay REGENXBIO up to $1.75 billion for the rights to develop and commercialize its treatment of various eye conditions.

REGENXBIO and AbbVie Officially Ink Eye Care Collaboration Deal Worth Up to $1.75 Billion

Editor of Pharmaceutical Technology Europe

Chris Spivey is the editorial director of 

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part one of four, 

serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective

Watch part 3: serialization from a software perspective

Watch part 4: serialization from a regulatory perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is a senior manager (packaging engineering) and serialization program lead with Thermo Fisher Scientific’s Pharma Services, a contract development and manufacturing organization. David has 25 years of experience in the pharma industry, including manufacturing, validation, packaging, engineering, and serialization.

 is an engineering project manager for Catalent Biologics, a contract development and manufacturing organization. Rebecca has more than 13 years of experience in the pharmaceutical industry and project management. Rebecca is responsible for managing the design, implementation, and qualification of large capital projects within the biologics business.

 is the director of corporate projects at Recipharm, a contract development and manufacturing organization. Staffan has between June 2015 and April 2019 acted as program manager for the Recipharm global serialization project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.

Watch other videos in this keynote series

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Manufacturing | Part 1

The European Medicines Agency announced on Nov. 11, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing two monoclonal antibody (mAb) drugs to treat COVID-19 patients.

Ronapreve (casirivimab/imdevimab) (Roche Registration GmbH) is being recommended for the treatment of COVID patients who do not require supplemental oxygen but are at risk for severe disease and who are 12 years of age (weighing at least 40 kilograms) and older. It may also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms.

CHMP is recommending authorizing Regkirona (regdanvimab) (Celltrion Healthcare Hungary Kft) for treating adults with COVID-19 at risk for severe disease who do not require supplemental oxygen.

Both mAbs are the first to receive a positive CHMP opinion for treating COVID-19. The committee reached its decision after evaluating data from studies that showed the drugs significantly reduced hospitalization and death in COVID-19 patients. According to EMA, the chance of being infected by a household member with COVID-19 was reduced with Ronapreve.

Both recommendations will be sent to the European Commission for approval.

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

EMA Recommends Two COVID-19 Treatments

Then European Medicines Agency (EMA) announced on Nov. 10, 2021 that it has begun evaluating Moderna’s application to extend the use of its COVID-19 vaccine, Spikevax, to children ages 6–11. The agency’s Committee for Medicinal Products for Human Use (CHMP) will review vaccine data and results from an ongoing clinical study that includes children aged 6–11. EMA anticipates the evaluation to take two months, approximately. Once the CHMP reaches an outcome from the review, its opinion will be forwarded to the European Commission for a final decision.

Spikevax is currently authorized in the European Union for use in people 12 years and older.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

EMA Starts Evaluation of Moderna’s COVID-19 Vaccine for Children

On Nov. 10, 2021, CPhI Worldwide announced the winners of the 2021 CPhI Pharma Awards. The awards are given out to leaders in the industry who demonstrate “Excellence in Pharma” and were announced at a ceremony at Stella Polare, Fiera Milano in Milan, Italy on Nov. 9, 2021 during the CPhI Worldwide event.

The awards categories, along with the winners, are listed as follows:

Excellence in Pharma: CEO of the Year—


Excellence in Pharma: Packaging & Drug Delivery—


 for its prefilled and preloaded wearable drug delivery platform

Excellence in Pharma: Supply Chain, Logistics, and Distribution—


 for its Supplier Compliance Management Software

for its strong commitment to the community

Excellence in Pharma: Innovation in Response to COVID-19—


 for its speed of committing to 1.1 billion vaccine doses of COVAX

Excellence in Pharma: Finished Formulation—


 for the development of androgen and metabolic therapies

Excellence in Pharma: API Development—


 for their program to boost biological drug development

Excellence in Pharma: Digital Innovation—


 for its real-world evidence methodology for regulatory purposes in noncommunicable diseases, artificial intelligence, machine learning, and deep learning

Excellence in Pharma: Regulatory Procedures and Compliance—


Excellence in Pharma: Manufacturing Technology and Equipment—


 for its In-Cavity Powder Liquid 3D Printing solution.


“Despite the challenges of the past 18+ months, the pharmaceutical industry has shown both incredible resilience and a continued pursuit of innovation, something which is clearly reflected in the extremely high standard of entries for this year’s CPhI Pharma Awards,” stated Tara Dougal, Head of Content & Insights, Informa Markets, in a press release. “I’d like to thank our sponsor, Rentschler Biopharma and especially our jury, who lent their time and expertise to assessing the many entries we received. Lastly, I’d like to extend congratulations to all of the nominees for their achievements, and of course to this year’s winners!”

More information about the awards can be found at 

The winners of the 18th CPhI Pharma Awards, which are given as a recognition of ‘Excellence in Pharma’, were announced on November 9, 2021, in Milan.

CPhI Announces 2021 Pharma Awards Winners

Feliza Mirasol is the science editor for 

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies was part of a keynote series at INTERPHEX 2021. This is Part 2 of 2.

The progression of increasingly complex biological molecules in early drug development poses unique challenges to their analytical characterization, which, in turn, impacts the design and approach of biomanufacturers to the bioprocesses needed to produce these molecules, both in the lab and at scale up/scale out. This session will explore current advances in analytical methodologies and equipment starting at the benchtop and carrying through to process analytics and process development.

Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

Gregory Berger, Product Manager, Virus-based Therapeutics—Gene Therapy, Sartorius

Greg is part of the Viral Based Therapeutic product management team at Sartorius bringing a wealth expertise in viral vector/cell line development, vector production in bioreactors and development of appropriate analytical tools for characterization and functionality assessment. Greg obtained his PhD in Virology and Immunology from the Ecole Normale Superieure de Lyon (ENS Lyon) in France, focusing upon the development of new Lentiviral vectors for the development of Dendritic cell-based immunotherapy. He then joined the department of Immunobiology and Infectious Disease at King’s College London as a post-doctoral researcher where his work focused predominantly on viral vector integration and immune cell dysfunction upon transduction. Prior Joining Sartorius, Greg worked at the Cell and Gene Therapy Catapult where he led the development of an End-to-End AAV manufacturing platform to address the current challenges regarding viral vector manufacturing.

Ahmed Besheer, Head Formulation Development, Lonza Drug Product Services

Ahmed Besheer has extensive experience in drug product development, with ten years of industry experience. Before joining Lonza in 2018, Ahmed worked at Novartis and Merck Serono in parenteral formulation development as DP project lead and later as head of NBE formulation development. At Lonza, Ahmed leads a team that develops drug products of monoclonal antibodies, recombinant protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and viral vectors. He has extensive experience in the formulation of liquid and lyophilized early- and late-phase Drug Product for various administration routes.

Ahmed earned his pharmacy degree from Ain Shams University, Cairo (EG), holds a PhD in pharmaceutical technology from the University of Halle (DE), and worked as an assistant professor at the University of Munich (DE)

Lowell Brady, Head Drug Product Phys-Chem Analytical Development, Lonza Drug Product Services

Lowell Brady leads the Phys-Chem analytical development team at Lonza Drug Product Services, which is responsible for analytical method development and support of specification setting and the analytical control strategy for customer products. Prior to joining Lonza, Lowell worked in analytical and CMC roles at large biotech and pharmaceutical companies. Lowell has a broad range of expertise ranging from in-depth characterization of protein therapeutics using mass spectrometry to the development of routine quality control methods for product release and stability testing. Lowell has experience defining strategies for supporting all stages of product and process development, from early pool/clone screening through BLA filings.

Sébastien Ribault, PhD, Vice-President and Head of End-to-End Solutions, part of the BioReliance® portfolio, MilliporeSigma

Sébastien joined MilliporeSigma in 2005 and is vice-president and head of End-to-End Solutions and the managing director of the Biodevelopment Center located in Martillac, France, where he leads the CDMO branch dedicated to large molecules within MilliporeSigma. Sébastien also supports the development of new and innovative biomanufacturing technologies and solutions in collaboration with the company’s process development team.

Prior to joining MilliporeSigma, he was a gene therapy development scientist at Transgene and was head of the R&D laboratory and member of the board of directors at Hemosystem, an in-vitro diagnostics company. Sébastien received his microbiology engineer degree from the Engineer School of Luminy, Marseille, France and his PhD in molecular and cellular biology from the University of Strasbourg.

Marc Hummersone, Senior Director, Research & Development, Astrea Bioseparations

Marc Hummersone has over 20 years of project and managerial experience in both big and small technology companies, including industry leaders AstraZeneca, General Electric Healthcare, and Cytiva. He has a broad experience base across a wide range of technologies including the development of novel chromatographic media for the purification of complex biological feed streams as well as drug discovery and development. He was a key contributor to the development of the Fibro chromatography family of products which resulted in the acquisition of Puridify, by GE Healthcare in 2017. Additionally, he was a key part of the management team who validated the concept of synthetic lethality and who identified and developed Lymparza, which is an approved drug for the treatment of BRCA-mutated advanced ovarian cancer which resulted in the acquisition of KuDOS Pharmaceuticals in 2005, by AstraZeneca. Marc has held positions including Company Director, Chief Scientific Officer and Department Director. He gained a PhD and Post-Doctoral experience in chemistry which was focused on the total synthesis of complex natural products at University College, London.

Watch other videos in this keynote series:

Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 2

Flagship Pioneering, the firm that founded Moderna and many other companies in the health sector, announced on Nov. 9, 2021, that it would be officially launching a transfer ribonucleic acid (tRNA) platform company, Alltrna. Founded at Flagship Labs in 2018, Alltrna has mapped tRNA biology to design tRNA medicines for various diseases driven by genetic mutations. Flagship has made an initial commitment of $50 million to Alltrna.

According to a company press release, various diseases stem from the same nonsense mutation, where the code for an amino acid has mutated into a “stop” codon. This results in a truncated or shortened protein product that is at the root of many genetic diseases. To combat this, Alltrna has designed a tRNA that can read these stop codons and deliver the desired amino acid, restoring production of the correct, full-length protein. If successful, a single tRNA medicine could treat various diseases with the same underlying genetic mutation.

"Alltrna builds on the more than decade long exploration, conducted at Flagship Labs, focusing on the RNA world as a source of programmable therapeutic modalities," said Noubar Afeyan, co-founder and chairman of Alltrna and CEO of Flagship Pioneering, in the press release. "With Alltrna's platform we are leveraging tRNAs as the critical gatekeepers of protein production to target our central translation code for unprecedented therapeutic effect."

According to the press release, Alltrna's tRNA platform harnesses the combinatorial potential of the hundred-plus different modifications possible at each nucleotide position. The stable structure, small size, and diversity of tRNAs make them ideal candidates for therapeutic treatments.

"We have built the world's first tRNA therapeutic platform by combining the extensive learnings at Flagship in RNA design and delivery with a reinforced learning framework that unlocks the relationship of tRNA modality to biological output, disease application, and drug design," said Lovisa Afzelius, origination partner at Flagship Pioneering and founding CEO of Alltrna, in the press release. "Since the company's founding, we have established a deep understanding of tRNA biology and its diverse combinatorial modifications to systematically design, program, and deliver tRNAs to correct disease."

Flagship Pioneering has officially launched Alltrna, a company planning to combat genetic diseases with transfer ribonucleic acid (tRNA) medicine.

Flagship Pioneering Launches Transfer RNA Company, Alltrna

Birmingham Biotech, a biotechnology company specializing in diagnostic tests, protective nasal sprays, and mobile medical facilities, announced on Nov. 9, 2021, that it had reached a licensing agreement with the University of Birmingham to commercialize their antiviral nasal spray. Designed by Professor Liam Grover, a member of the university’s Healthcare Technologies Institute, the nasal spray is designed to protect against COVID-19.

“As COVID-19 restrictions around the world are gradually lifting, there is a real need for effective methods of viral protection,” said Grover in a Birmingham Biotech press release. “While existing measures like wearing masks and handwashing remain essential, this nasal spray provides an additional protective measure with the potential to reduce transmission. We are thrilled to be working with Birmingham Biotech to bring the [antiviral] nasal spray to individuals around the world.”

According to the press release, the spray is designed to work by encapsulating and deactivating the virus while it is still in the nose, preventing wider uptake by the body. It is formulated with two compounds: a polysaccharide gel that coats and retains the virus, so it does not travel further down the respiratory tract, and carrageenan, an antiviral agent. According to the Birmingham researchers, carrageenan completely inhibited SARS-CoV-2 activity.

“We are delighted to enter into a partnership with the University of Birmingham and to be able to work together with its world-leading academic researchers, to advance medical innovations,” said Michael Hsu, managing director of Birmingham Biotech, in the press release. “We have a shared commitment to bring our proprietary anti-COVID-19 nasal spray to as many people as possible at an affordable price, focusing on developing markets with the greatest need.”

The licensing agreement covers the entire duration of the patent and gives Birmingham Biotech exclusive marketing and sale rights outside of India. According to the press release, the nasal spray is expected to be available in the United Kingdom and Asia in early 2022.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

Birmingham Biotech and the University of Birmingham Sign Licensing Agreement for Antiviral Nasal Spray Against COVID-19

The European Medicines Agency announced on Nov. 8, 2021 that it will be reviewing data available on the use of molnupiravir (MK 4482 or Lagevrio) as a treatment for COVID-19 prior to authorization. A rolling review of the drug is currently ongoing. The agency’s Committee for Medicinal Products for Human Use (CHMP) will provide recommendations to national authorities in the European Union regarding the possibly early use of the medication. The decision came because of the rise in infections across the EU.

“EMA and HMA [Heads of Medicines Agencies] remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy. EMA will communicate on the outcome of this review and that of the rolling review once they conclude,” the agency stated in a 

Molnupiravir, an oral antiviral medicine that reduces the ability of SARS-CoV-2 to multiply in the body, was developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.

EMA Begins Review of COVID-19 Treatment

xPfizer announced on Nov. 5, 2021, that its investigational novel oral antiviral candidate Paxlovid (PF-07321332; ritonavir) significantly reduced severe risks of COVID-19 in a recent clinical trial. According to an interim analysis of the Phase II/III Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, ritonavir demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause within three days of onset relative to the placebo group.

EPIC-HR was a randomized, double-blind study of non-hospitalized patients with COVID-19 considered to be at high risk of progressing to severe illness. Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection within a five-day period with mild to moderate symptoms. They were required to have at least one characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

Two groups of patients (randomized 1:1 to receive ritonavir or placebo every 12 hours for five days) were evaluated: those treated within three days of symptom onset, and those treated within five days. In the former group, 0.8% of patients who received ritonavir (3/389) were hospitalized through Day 28; no deaths were reported in this patient group. In that same time frame, 7.0% of patients who received placebo (27/385) were hospitalized; seven deaths were reported in this group.

These values were comparable to those in the five-day group, which reported 1.0% (6/607) and 6.7% (41/612) hospitalization rates, respectively. No deaths were reported in this ritonavir group, while three patients in the placebo group died.

Treatment-emergent adverse events were comparable between ritonavir (19%) and placebo (21%). Among the patients evaluable for treatment-emergent adverse events, fewer serious adverse events (1.7% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.1%) were observed in patients dosed with ritonavir compared to placebo.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” said Albert Bourla, chairman and CEO, Pfizer, in a company press release. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”

According to the press release, at the recommendation of an independent data monitoring committee and FDA, Pfizer will cease further enrollment in the study. Pfizer plans to submit the data as part of its ongoing rolling submission to FDA for Emergency Use Authorization as soon as possible.

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Pfizer Pill Reduces Severe COVID-19 Risks by 89% in Phase II/III Study

Element Materials Technology announced on Nov. 4, 2021, that it had signed an agreement to acquire JMI Laboratories, a company specializing in performing antimicrobial resistance surveillance studies.According to a company press release this move was made to strengthen Element’s North American offerings.

JMI uses their proprietary SENTRY Antimicrobial Surveillance Program to perform antimicrobial resistance monitoring studies for FDA regulatory and new drug application submissions. The company also offers microbiology and molecular testing services to assist in development and clinical trial support.

This acquisition is the latest in a series of acquisitions Element has made throughout 2021. Most recently, they purchased a pharmaceuticals contract development and manufacturing organization, 

, in October, and an extractables and leachables specialist, 

“JMI’s SENTRY surveillance program, with over 20 years of data from over 130 hospitals across 40 countries, is a real differentiator,” said Jo Wetz, CEO, Element, in the press release. “Resistance to antibiotics is a clear and present threat to public health on a global scale. With JMI’s team of renowned experts, Element is now positioned to play an important role in helping to address the growing risk of antimicrobial resistance.”

“After 20 years of operation and having built a strong reputation for our expertise and client relationships, we are proud to be joining the Element group,” said Andrew Fuhrmeister, CEO, JMI, in the press release.“This move will bring us wider global access through the Element network and will allow us to work within the expanded life sciences offering, building industry leadership.”

Element’s acquisition of JMI Laboratories will increase their North American service offerings.

Element Acquires JMI Laboratories

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies was part of a keynote series at INTERPHEX 2021. This is Part 1 of 2.

Marc Hummersone has over 20 years of project and managerial experience in both big and small technology companies, including industry leaders AstraZeneca, General Electric Healthcare, and Cytiva. He has a broad experience base across a wide range of technologies including the development of novel chromatographic media for the purification of complex biological feed streams as well as drug discovery and development. He was a key contributor to the development of the Fibro chromatography family of products which resulted in the acquisition of Puridify, by GE Healthcare in 2017. Additionally, he was a key part of the management team who validated the concept of synthetic lethality and who identified and developed Lymparza, which is an approved drug for the treatment of BRCA-mutated advanced ovarian cancer which resulted in the acquisition of KuDOS Pharmaceuticals in 2005, by AstraZeneca. Marc has held positions including Company Director, Chief Scientific Officer and Department Director.He gained a PhD and Post-Doctoral experience in chemistry which was focused on the total synthesis of complex natural products at University College, London.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.