Early investment in formulation strategies will maximize the chance of success.

The Earlier the Better in Formulation

Advances in simulation and the development of digital twins.

Computational Fluid Dynamics in Upstream Biopharma Manufacturing

Different methods give different answers when calculating limits for impurities.

Detecting and Determining Quantitation Limits for Impurities

Automatic visual inspection machines and AI highlight inspection deficits.

Visual Inspection: Seeing Room for Improvement?

Despite their promise, alternative drug delivery approaches are complex and must be justified.

Taking an Alternative Approach to Drug Delivery

Traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data. 

Practical SPC Rules to Apply on Pharmaceutical Process Data

Novavax COVID-19 Vaccine Receives EUA in Indonesia

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

Researchers from the Massachusetts Institute of Technology (MIT) announced the development of novel nanosensors for the detection of nucleocapsid and spike protein of the SARS-CoV-2 virus in a Nov. 10, 2021 press release. The Corona Phase Molecular Recognition (CoPhMoRe) sensors were born out of a collaboration between MIT and InnoTech Precision Medicine, an early-stage diagnostics company. and developed within a short timeframe of 10 days.

According to research findings published in 

 in October 2021 (1), researchers used single-walled carbon nanotubes and polymers to develop the CoPhMoRe sensors. These sensors aim to provide a platform for quick development of fast and accurate diagnostic, monitoring, and surveillance tests for detection of current and emergent pathogens.

“New technologies using innovative material and strategies are key for quick and efficient diagnosis and disease control.” said Roya Khosravi-Far, CEO and co-founder of InnoTech, in the press release. “Conventional diagnostics are expensive, specialized, and slow to develop; we need to modernize our diagnostic tests to drive robust public health response to existing and emerging threats.”

Articles

Researchers from MIT have developed novel nanosensors for the detection of the nucleocapsid and spike protein of the SARS-CoV-2 virus.

New Carbon Nanotube-Based Sensor Can Detect SARS-CoV-2 Proteins 

Novozymes and Novo Nordisk Pharmatech have formed a collaboration to develop specialty enzymes for use in biopharmaceutical processing and regenerative medicines, with a focus on stem cell and gene therapies. The companies expect to have an initial product within a few years that will be brought to commercialization, they announced in a Nov. 25, 2021 press release.

Novozymes brings extensive enzyme diversity, a large enzyme portfolio, a broad enzyme R&D platform, and strong fermentation capabilities to the collaboration. For its part, Novo Nordisk Pharmatech has recently invested in a purification plant for enzymes for high-quality biopharmaceutical production.

Specialty enzymes are in high demand in the biopharmaceutical industry, driven by the production of proteins and cells, according to the company press release. Older production technologies are increasingly being replaced by enzymatic alternatives, especially in the area of regenerative medicines, which require high quality, pharmaceutical-grade enzymes.

“I am very excited about this collaboration, where synergies between the companies in the Novo Group will come into play and with the prospect of enabling scale-up of processes in the regenerative medicines market,” said Ulla Grove Krogsgaard Thomsen, CEO of Novo Nordisk Pharmatech, in the press release.

Novozymes and Novo Nordisk Pharmatech are teaming up to develop best-in-class technical enzymes to support biopharmaceutical production processes.

Novozymes and Novo Nordisk Pharmatech Collaborate on Enzymes for Biopharma Production

BeiGene, a biotechnology company, has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell, NJ, on which it will build a new state-of-the-art manufacturing campus and clinical R&D center for advanced medicines. The company states in a Nov. 23, 2021 press release that it is investing in US manufacturing to expand and diversify its global supply chain and build new manufacturing capabilities for its biologics and drug pipeline.

BeiGene expects to invest several hundred million dollars in the initial phase of construction at the Hopewell site as well as the acquisition of the property, pending finalization of development plans. The new facility is expected to include up to approximately 400,000 ft2 of dedicated commercial-stage biologic pharmaceutical manufacturing. It will house up to 16,000 L of biologics capacity, along with clinical R&D and office space.

The initial phase of construction is expected to begin in 2022, with completion slated in late-2023 or in 2024. The property will additionally have more than one million square feet of developable real estate for potential future expansion.

“With this property acquisition, we plan to establish a flagship manufacturing and clinical R&D center in the [United States] to diversify our global supply chain. We are proud to take this next step in our journey to advance impactful treatments and make them more accessible to patients around the world,” said John V. Oyler, co-founder, chairman, and CEO of BeiGene, in the company press release. “We have already begun hiring additional colleagues from the deep talent pool in New Jersey and look forward to serving as a member of the thriving Princeton-Hopewell business community.”

“We are extremely excited that BeiGene has taken the next step in the company’s push to manufacture innovative cancer medicines right here in New Jersey,” said Governor Phil Murphy, in the press release. “Our goal since day one has been to create an environment in New Jersey that fosters the growth of companies [such as] BeiGene, and we are excited to see what’s next as the company expands.”

“BeiGene's expertise in developing innovative cancer treatments combined with their planned state-of-the-art facility makes this a win-win-win for Hopewell, BeiGene, and the millions of cancer patients whose lives will hopefully improve from BeiGene medicines. We are proud that those medicines will be manufactured right here," said Hopewell Township Mayor Julie Blake, in the press release.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

BeiGene Acquires Property in New Jersey to Build Manufacturing and Clinical R&D Center

Samsung Biologics; GreenLight Biosciences, a biotechnology company specializing in RNA products; and Environmental Impact Acquisition Corp, a special purpose acquisition company, have formed a collaboration under which Samsung Biologics will manufacture GreenLight’s messenger RNA (mRNA) COVID-19 vaccine candidate at commercial scale.

Under the agreement, the partnership will aim to accelerate production of GreenLight’s COVID-19 vaccine candidate for Phase III clinical trials and commercial sales, pending regulatory approval. Samsung will leverage GreenLight’s existing manufacturing process. Technology transfer from GreenLight to Samsung will start immediately, the companies stated in a Nov. 24, 2021 press release.

“We are delighted to partner with Samsung to manufacture [mRNA] for our [COVID] vaccine trial. There is an urgent need to develop vaccines for the whole world,” said GreenLight CEO Andrey Zarur, in the press release. “Our vaccine trial will open the way to make vaccines that are available to everybody, not just citizens of developed countries.”

“We are delighted to partner with GreenLight to leverage our expertise in manufacturing a [mRNA] COVID-19 vaccine candidate to better serve patients in lower income countries,” said John Rim, CEO of Samsung Biologics, in the press release. “This collaboration demonstrates a major milestone for Samsung Biologics as we will commence our expanded capabilities and operations to provide one-stop end-to-end messenger RNA production from [drug substance] (DS) to [aseptic fill finish] (DP) to commercial release, all from a single site. At this time of urgent global demand, we will strive for seamless service across our biomanufacturing network to fight the COVID pandemic and in turn, help make progress towards Korea's vaccine hub goal.”

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp to Build mRNA Vaccine Manufacturing Capacity

A SARS-CoV-2 variant first identified in South Africa was designated 

 as a variant of concern, named Omicron, by the World Health Organization (WHO). Further study is underway to evaluate whether the B.1.1.529 (Omicron) variant is more transmissible or causes more disease and whether current vaccines and treatments continue to be effective countermeasures.

Vaccine makers have been monitoring variants and continuing to evaluate the effectiveness of their vaccines. Pfizer and BioNTech continue to conduct surveillance efforts focused on monitoring for emerging variants. “We are beginning to run neutralization tests on the new Omicron variant of concern and expect to have initial data in the coming weeks,” said a Pfizer spokesperson in a statement. “In the event that a variant emerges that escapes protection of our vaccine, Pfizer and BioNTech expect to be able to develop and produce a tailor-made vaccine against that variant in approximately 100 days, subject to regulatory approval.”

 that it was working to test the ability of its current, FDA-authorized 50-µg mRNA-1273 vaccine booster dose to neutralize the Omicron variant and expected data in the coming weeks. The company said that if the 50-µg dose proved insufficient, it would turn to a 100-µg booster dose that is already under study to investigate its neutralizing protection against Omicron. Moderna also has two multivalent booster candidates, designed to anticipate mutations such as those that have emerged in the Omicron variant, in clinical studies. According to the press release, the first candidate (mRNA-1273.211) includes several mutations present in the Omicron variant that were also present in the Beta variant of concern, and a second multivalent candidate (mRNA-1273.213) includes many of the mutations present in the Omicron variant that were also present in the Beta and Delta variants. The company said it would also advance an Omicron-specific booster candidate (mRNA-1273.529). Moderna said it was advancing these three lines of defense in parallel.

“From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves. The mutations in the Omicron variant are concerning, and, for several days, we have been moving as fast as possible to execute our strategy to address this variant,” said Stéphane Bancel, CEO of Moderna, in the press release.

 that it was confident in the robust immune response of its COVID-19 vaccine against variants to date in clinical studies. “We will not be complacent. Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real world effectiveness studies being conducted with the Johnson & Johnson COVID-19 vaccine, we will work together to generate new data on Omicron,” said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson, in 

. “In parallel, we have begun work to design and develop a new vaccine against Omicron and will rapidly progress it into clinical studies if needed.”

, AstraZeneca said it was examining the impact of Omicron on its vaccine and was collecting real-world data. The company also said it was testing its long-acting antibody combination against the variant and was hopeful it would retain efficacy.

Sources: WHO, Pfizer, Moderna, Johnson & Johnson, Reuters

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions. 

Vaccine Makers Seek to Address Omicron SARS-CoV-2 Variant

Pfizer and BioNTech announced in a Nov. 25, 2021 press release that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine, Comirnaty, in children five to under 12 years of age. The European Commission (EC) will review the CHMP recommendation. If the EC grants a variation to the Conditional Marketing Authorization (CMA), the decision will be immediately applicable to all 27 European Union member states. If authorized, Comirnaty will be the first COVID-19 vaccine authorized in the EU for individuals five to under 12 years of age. The current CMA was granted for people 12 years of age and older, and it was expanded to include a booster dose at least six months after the second dose in people 18 years of age and older.

The positive opinion adopted by the CHMP is based on scientific evidence, including results from a Phase II/III randomized, controlled trial that showed a favorable safety profile, robust immune responses, and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from seven days after the second dose, during a period when Delta was the prevalant strain, the companies said in the press release. The companies have also submitted requests for authorization of their COVID-19 vaccine in the five to 12 age group to other regulators around the world, and data from ongoing clinical studies in younger ages is upcoming. 

Pfizer and BioNTech do not expect the introduction of pediatric doses to impact the existing supply agreements in place with governments and international health organizations around the world.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age. 

EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children 

GreenLight Biosciences, a biotechnology company, and Samsung Biologics, a global contract development and manufacturing organization (CDMO), have partnered up to advance GreenLight’s messenger RNA (mRNA) COVID-19 vaccine candidate, it was announced in a Nov. 25, 2021 press release.

Under the terms of the partnership, Samsung will manufacture GreenLight’s vaccine candidate for Phase III clinical trials and commercial sales (subject to regulatory approval). GreenLight’s existing manufacturing process will be leveraged by Samsung, with technology transfer between the companies already underway.

“We are delighted to partner with Samsung to manufacture messenger RNA for our COVID vaccine trial. There is an urgent need to develop vaccines for the whole world,” said GreenLight CEO Andrey Zarur, in the press release. “Our vaccine trial will open the way to make vaccines that are available to everybody, not just citizens of developed countries.”

“We are delighted to partner with GreenLight to leverage our expertise in manufacturing a messenger RNA COVID-19 vaccine candidate to better serve patients in lower income countries,” added John Rim, CEO of Samsung Biologics, in the press release. “This collaboration demonstrates a major milestone for Samsung Biologics as we will commence our expanded capabilities and operations to provide one-stop end-to-end messenger RNA production from drug substance to aseptic fill/finish to commercial release, all from a single site. At this time of urgent global demand, we will strive for seamless service across our biomanufacturing network to fight the COVID pandemic and in turn, help make progress towards Korea's vaccine hub goal.”

Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.

GreenLight Biosciences, Samsung Biologics Collaborate to Advance COVID-19 Vaccine Candidate

Contract research organization (CRO), PathoQuest, has received a good manufacturing practice (GMP) certificate for its next-generation sequencing (NGS)-based quality control testing services that it performs at its facility in Paris, France.

According to a Nov. 24, 2021 press release, the GMP certificate was awarded after a recent inspection by the French National Agency for the Safety of Medicine and Health Products (ANSM). The certification makes PathoQuest the first French CRO capable of offering GMP grade NGS-based testing services for quality control of biological drugs.

“Obtaining the GMP certification confirms that our quality management system meets the requirements and is at the expected level by the health authorities,” said Violaine Mélen, PathoQuest’s Chief Quality Assurance & Regulatory Affairs officer, and qualified person, in the press release. “The GMP certification for our biosafety testing services completes our [good laboratory practice] certificate obtained in January 2020 and the Pharmaceutical Establishment status achieved in September 2020. Offering GMP-grade genomic testing services is our pledge of quality to the biopharmaceutical industry, the health authorities, and the safety of the patient.”

“Gaining this GMP certification is a major milestone in the implementation of PathoQuest’s growth strategy and strengthens our leadership in the quality control testing of biologics,” added Jean-Francois Brepson, PathoQuest’s CEO, in the press release. “By offering these testing services, we will enable our clients to entrust their vaccine, cell and gene therapy, and other innovative therapies projects to PathoQuest, from early preclinical phases to commercial supply. We believe this represents a tremendous advantage for biopharmaceutical companies when they evaluate contract manufacturing alternatives that are faster, safer, and 3R-compliant at a GMP grade. Those assets make PathoQuest the ideal partner.”

PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.

PathoQuest Achieves GMP Certification for Quality Control Testing Services

Donaldson Company, a provider of filtration products and solutions, has acquired Solaris Biotechnology, an Italian designer and manufacturer of bioprocessing equipment, for approximately €41 million (US$46.3 million). The acquisition was announced in a Nov. 23, 2021 press release.

“We are excited about Solaris’ capabilities and growth trajectory, and this acquisition is an important step on our journey towards strengthening our presence in the life sciences market,” said Tod Carpenter, chairman, president, and CEO of Donaldson, in the press release. “With Solaris, we are well-positioned to provide more comprehensive solutions to food and beverage customers and expand our access to biopharma and other key life sciences markets. We are committed to building our presence in these markets, and this acquisition, combined with a strong pipeline of opportunities for both focused organic growth and additional acquisitions, gives us confidence we can deliver on our strategic priorities while creating value for our stakeholders.”

“By being part of Donaldson, we will have the global scale and financial flexibility to continue delivering on our growth plans, and we are thrilled about this opportunity,” added Matteo Brognoli, co-founder and CEO of Solaris, in the press release. “Like Donaldson, Solaris is built on strong customer relationships and providing technologically advanced solutions. With the need for Solaris products expanding rapidly, we are better able to meet the growing need while playing an important role in Donaldson’s expansion into life sciences.”

Under the agreement, Brognoli will stay on with the company as managing director of Solaris. His responsibilities will be day-to-day operations and continued growth of the business.

Donaldson Company's acquisition of Solaris Biotechnology is intended to expand their footprint in the life sciences market.

Donaldson Company Acquires Italian Bioprocessing Equipment Specialist

Flywheel reported, in a Nov. 22, 2021 press release, that Roche and Genentech have successfully integrated its platform for ingestion, classification, standardization, curation, and analysis of medical imaging data.

The cloud-scale informatics platform is secure and allows the aggregation and management of medical imaging and associated data to advance drug discovery. Data are organized and processed via automated pipelines, which is time efficient and reduces the potential for human error in drug development.

“Manual processes to curate data at the terabyte and petabyte levels are historically costly, time-consuming and prone to human error. With our platform in place, Roche and Genentech researchers can access high-quality images for complex analysis and machine learning, ultimately speeding the development of innovative therapies,” said Jim Olson, CEO of Flywheel, in the press release. “Before using the platform, this level of collaboration and analysis was simply not possible.”

“At Roche we envision a future where data, analytics and digital technologies routinely enable more targeted, efficient research and development and more integrated, personalized care,” added James Sabry, head of Roche Pharma Partnering, in the press release. “The Flywheel platform enables rapid access to highly-curated imaging data, enhancing our ability to answer key scientific questions that are critical to advancing better patient care experiences and outcomes.”

Flywheel's platform will aid Roche and Genentech in the aggregation and management of medical imaging data.