Advance planning is essential to ensure a reliable supply for parenteral drug packaging

A Clear Strategy for Primary Packaging

Consistency, robustness, and API-excipient understanding are essential for successful drug release.

On-Time Drug Delivery

Despite challenges caused by COVID-19, M&A activity in life sciences is recovering well.

Analyzing European M&A Activity Post-COVID

Intelligent analytical tools detect impurities in small-molecule drug ingredients.

The Search for Unknown Impurities

Okra gum serves as a polymer for oral drug formulations.

Novel Drug Delivery Using Okra Gum

Microbial experts should employ proactive practices on the manufacturing floor.

Optimizing Microbial Control

Next Big COVID Challenge: Vaccines for Little Kids

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Pharma strategizes to reduce its environmental footprint while optimizing output.

Greener API Manufacturing

In an article published in the American Chemical Society (ACS) journal 

, researchers from the CAS Center for Excellence in Nanoscience at the National Center for Nanoscience and Technology in Beijing announced positive results concerning a microneedle patch as an alternative COVID-19 vaccine delivery mechanism. According to ACS researchers, mice that were given the vaccine through the micropatch demonstrated a strong immune response.

Of the three current vaccines authorized by FDA, one is based on protein and two on RNA. All three must be stored in cold temperatures, which has caused issues with getting them to countries with less access to temperature-controlled shipping and storage facilities. However, micropatch vaccines can be stored for over 30 days at room temperature, making them significantly easier to transport.

Additionally, according to an ACS press release on Sept. 22, 2021, traditional vaccines must be injected into a muscle, but immune cells typically aren’t found in muscles. The skin, however, contains antigen-presenting cells (APCs) and could potentially present a stronger immune response, should the injection mechanism deliver it there.

The vaccine used by the researchers was DNA-based. While the researchers state that it is easier to make than an RNA or protein vaccine, and more stable than RNA vaccines, intramuscular DNA vaccines have had limited effectiveness because the DNA must find its way inside the cell nucleus to work. However, by delivering the vaccine into the skin, researchers hypothesized that it would have a greater chance of making it into the nucleus of APCs.

The study received funding from the National Natural Science Foundation of China and the Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, Chinese Academy of Sciences.

Detailed results of the study can be seen in a 

Articles

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

Researchers Cite Positive Results in COVID-19 Microneedle Patch Trial

On Sept. 22, 2021, Biden convened heads of state, leaders from international organizations, notable figures from private sectors, and other partners for a virtual conference known as COVID-19 Summit: Ending the Pandemic and Building Back Better.

There were four key themes of the summit:

In accordance with these objectives, President Biden announced how the United States is planning on playing their part. Most notably, he declared that the US would donate an additional 500 million Pfizer-BioNTech COVID-19 vaccines to low- and lower-middle income countries. This almost doubles the number of doses donated by the US to over 1.1 billion doses.

Notable financial commitments made by President Biden on behalf of the US include $370 million toward global vaccine readiness, $250 million toward existing response efforts, and $1.4 billion towards reducing morbidity and mortality from COVID-19, mitigating transmission, and strengthening health systems, among others.

Biden also expressed interest in expanding production of mRNA, viral vector, and/or protein subunit COVID-19 vaccines for low- and lower-middle income countries. He called on other countries to prioritize vaccine tracking, response, and prevention.

“We’re not going to solve this crisis with half-measures or middle-of-the-road ambitions,” said Biden 

. “We need to go big. And we need to do our part: governments, the private sector, civil society leaders, philanthropists. This is an all-hands-on-deck crisis.”

Biden outlines a plan to end the pandemic in a virtual global conference.

Biden Hosts Global COVID-19 Summit

GlaxoSmithKline (GSK) has received a positive recommendation from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

According to a Sep. 17, 2021 press release, the three positive opinions have been based on data from pivotal studies investigating the role of targeted interleukin-5 (IL-5) inhibition with mepolizumab in hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and chronic rhinosinusitis with nasal polyps (CRSwNP). The CHMP’s recommendation will be put forward to the European Commission for final consideration of marketing authorization.

“We are pleased with the CHMP’s positive opinions as there are currently limited targeted treatment options available for patients in Europe with eosinophil-driven disease,” said Christopher Corsico, senior vice-president development, GSK, in the press release. “If approved, mepolizumab would be the first targeted treatment available for use in four of these diseases and would further reinforce its role in targeting the underlying cause of inflammation.”

GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

GSK Receives Positive Opinion from CHMP for Nucala

The first part of the 2021 CPhI Annual Report has been published, as announced in a Sep. 23, 2021 press release, and predicts a strong outlook for contract development and manufacturing organizations (CDMOs) over the next few years.

In part one of the report, experts Kevin Bottomley (partner at Results Healthcare) and Adam Bradbury (analyst at GlobalData PharmSource) highlight the pandemic, coupled with record investments in the discovery pipeline as catalysts for the CDMO growth. Additionally, the experts specify that these factors will positively impact M&A activity.

According to the findings in the report, there is a drive from the largest CDMOs to expand quickly so that they can meet both current and anticipated future demand. Financially, private equity (PE) is a major factor for growth as a result of the attractiveness of the CDMO industry for investment, particularly for high-margin products such as biologics.

“Scale is a major contributor to valuation across the sector due to the scarcity of scale assets. Companies with an EV (Enterprise Value) >$200 million command a premium over smaller players. We don’t see a significant difference in median valuation between pureplay API vs. drug product CDMOs,” said Bottomley in the press release. “However, there appears to be an investor premium for full-service CDMOs (development services, API, and drug product) who on average receive a higher valuation compared with pureplay API or drug product CDMOs. Deal activity in this sector is strongly driven by private equity. Over 60% of deals in 2020 and 2021 YTD (year-to-date) have been executed by PE or PE-backed companies.”

Analysis from GlobalData, reported in the press release, has further emphasized the confidence in the market as the number of PE houses buying CDMOs is greater than the number selling CDMOs. However, market preferences are shifting more towards specialist CDMOs and biologicals.

“There is no reason why this M&A activity cannot continue over the next two to three years,” added Bradbury, in the press release. “COVID-19 vaccine developers signed contract manufacturing agreements at an unprecedented rate during 2020/21 because many of these sponsors are small companies or non-profit institutions that lack manufacturing capabilities. Even the largest companies require extra capacity to supply billions of doses.”

The full report will be released during CPhI Worldwide, which is taking place in-person between November 9–11, 2021 in Milan, Italy, and online between October 25 and November 19, 2021.

The first part of the 2021 CPhI Annual Report has been published and predicts a strong outlook for CDMOs over the next few years.

CPhI Reports Strong Outlook for Outsourced Services in Near Future

The organizers of Pharmapack Europe, the region’s drug delivery and packaging show that will be held as a hybrid event in 2021, have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

Within the report, which can be downloaded from the Pharmapack website, are details of the Innovation Index—a market perception measure of each country’s drug delivery and device innovation. The 2021 index shows that the US is in the lead for innovation ranked at 8.26 out of 10, with Germany and Japan ranked as the second and third most innovative countries, respectively. India gained the biggest difference in its score versus 2020 in terms of innovation.

“There has indeed been a lot of activity and interest from Indian and Chinese organizations focused on developing lookalike models of existing European or US devices, including DPIs [dry particle inhalers] and soft mist inhalers,” said Andy Fry, founder, Team Consulting, in a Sep. 16, 2021 press release. “Such developments could well morph into completely new devices.”

Additionally, in the 2021 report, Pharmapack launched its inaugural Sustainability Index, which is a measure of how far long each country is towards achieving optimal sustainability for devices and packaging. European nations were top of the list for sustainability with Switzerland achieving the number one spot. For sustainability, the US was ranked as lower than all the European countries, and China and India were ranked poorly by the executives who participated in the survey.

The 2021 event returns after an 18-month hiatus due to the COVID-19 pandemic. The hybrid program starts on September 27, 2021 with online content and networking, which runs through until October 22, 2021. The in-person event will be taking place at the Paris Expo, Porte de Versailles on October 13–14, 2021.

“We are incredibly eager to welcome back the pharma packaging, drug delivery, and devices community after a year in which pharma’s innovation has never been more prescient,” said Sherma Ellis-Daal, brand manager for Pharmapack Europe, in the press release. “Yet, our research also shows the pandemic has accelerated a number of important existing trends in terms of connected devices, sustainable supply chains and remote patient administration. What’s exciting is that that with Pharmapack returning, we can provide the vital connections the industry relies upon to drive forward innovations and supply chains in 2022 and beyond.”

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

US Leads the Way for Drug Device Innovation but Lags Behind for Sustainability, Notes Pharmapack 2021 Report

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS). The regulatory authority’s decision was announced in a Sep. 18, 2021 press release.

Regdanvimab is a monoclonal antibody treatment that has been authorized for extended use in the treatment of COVID-19 in elderly patients (aged 50 years and over), or for those with at least one underlying medical condition with mild symptoms of COVID-19. Additionally, the approval covers treatment of adult patients with moderate symptoms of COVID-19. With this approval, regdanvimab becomes the first monoclonal antibody to be fully approved as a treatment for COVID-19.

“Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of regdanvimab in the treatment of patients with mild-to-moderate symptoms of COVID-19,” said HoUng Kim, PhD, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “Regdanvimab is the first of its kind for the treatment of COVID-19, so the efficacy and safety profile should be assessed thoroughly. Along with a continuous and positive feedback from expert scientists and clinicians, we are encouraged by the decision of regulatory agency to confirm this treatment is safe and effective. Celltrion group remains in diligent communication with other regulatory authorities worldwide.”

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS). 

Celltrion Gains Regulatory Nod in Korea for Regdanvimab

ProductLife Group (PLG), a regulatory compliance and outsourcing services specialist, and Juuka Advisory, an operations consulting company, have teamed up to form a new consulting offering, ProductLife Consulting. The partnership was announced in a Sep. 20, 2021 press release.

Both PLG and Juuka will draw from their expertise and operational experience to provide an end-to-end services portfolio for the pharma, biotech, medtech, and cosmetics markets through the new venture. ProductLife Consulting will be headed by Jean-Luc Taborin, who is Jukka’s CEO.

“I’m proud to join PLG, a leader in regulatory compliance outsourcing services,” said Taborin, in the press release. “With their knowledge of drug development, we’ll be able to tackle any perspective of the development of pharma, biotech, medtech, or cosmetics companies end-to-end.”

“This is a key milestone in PLG’s roadmap to strengthen its consulting offering with senior principals such as Jean-Luc and his team,” added Xavier Duburcq, CEO of ProductLife Group, in the press release. “PLG’s service offering and global footprint can now be proposed as a follow-up to any strategic recommendation that ProductLife Consulting makes to groups that want to accelerate and perform in their markets.”

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting. 

ProductLife Group and Juuka Advisory Partner Up on New Consulting Venture

FDA granted accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, according to a Sept. 20, 2021, FDA press release. According to the Seagen company press release, Tivdak is the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

In the innovaTV 204 clinical trial, 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen, received Tivdak. The trial showed a 24% objective response rate with a median duration of response of 8.3 months.

Tivdak is approved under FDA’s accelerated approval program based on tumor response and the durability of the response, according to Seagen’s press release. Verification and description of clinical benefit in confirmatory trials will impact any continued approval.

“TIVDAK’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them,” said Jan van de Winkel, CEO, Genmab, in Seagen’s press release. “The journey towards the approval of TIVDAK started nearly two decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of cancer patients and their families. Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators and our collaborators for their participation in our clinical studies.”

The biologics license application for Tivdak was submitted in Feb. 2021 and accepted with priority review in April 2021. The submission was based on the innovaTV 204 trial results.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA. 

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

In a Sept. 21, 2021, press release, Boehringer Ingelheim announced the acquisition of Abexxa Biologics, a biopharmaceutical company developing precision medicines for cancer treatments. The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell (rather than those expressed on the cell membrane).

Abexxa’s platform allows the targeting of intracellular antigens of cancer cells by recognizing their presentation on the cell surface by MHC class 1 molecules. While the Abexxa platform addresses the more common HLA-A2 peptide presentation, the company developed specific expertise in the nonclassical MHC class 1 molecule HLA-E, which has the potential to impact a broader set of cancer patients’ antigens, according to the press release.

Additionally, Abexxa developed a T-cell receptor-like antibody that can be used to disrupt the NKG2A:HLA-E immune checkpoint axis in oncology. Abexxa molecules are also being formulated to recruit immune cells targeting HLA-E peptide complexes on tumors.

“The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully to enable immune-targeting of cancer cells,” said Clive R. Wood, corporate senior vice-president and global head of discovery research, Boehringer Ingelheim, in the press release. “By expanding our portfolio of antibodies binding novel intracellular tumor antigens, we are striving to develop unique and broadly applicable new immunotherapeutic approaches for cancer patients.”

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

Boehringer Ingelheim Acquires Abexxa Biologics, Expanding Cancer Treatment Potential

Celsion Corporation, a clinical-stage company with a focus on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co., a generics manufacturer, announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine in a Sept. 17, 2021, press release. Under the terms of the amended agreement, Poly Pharm will manufacture clinical and commercial batches (pending approval for use for the latter) for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

Poly Pharm is experienced with chemistry, manufacturing, controls, process development, and current good manufacturing processes, including process optimization and manufacturing services to help customers advance new drug development projects. FDA, EMA, China’s National Medical Products Administration, and the World Health Organization have approved its sites and compounds, according to the company press release.

Madame Fang, CEO of Hainan Poly Pharm, said in the press release. “Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in highly cost-effective manufacturing of nucleic acid based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA vaccine technology platform is a promising platform as it may address global vaccine storage and distribution needs.”

“This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm,” said Michael Tardugno, chairman, president, and CEO of Celsion in the press release. “Our first collaboration is GEN-1, which incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is being evaluated in the Phase I/II OVATION 2 Study in combination with chemotherapy for patients with newly diagnosed advanced ovarian cancer. We have enjoyed a productive working relationship with Poly Pharm delivering quality product efficiently and are delighted to expand our contract manufacturing agreement with them.”

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

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