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Bio/pharma adjusts priorities amid demand for COVID-19 treatments.

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Meeting Development and Manufacturing Demands for Emerging Therapies

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On July 27, 2021, Cytiva and Pall, two subsidiaries of Danaher Corporation, announced that they will be making a $1.5 billion-investment toward expanding their manufacturing capacity and services.

The companies also released detailed plans on how the investment will be spent. The largest single investment, $600+ million, will go toward chromatography resins. Part of the $600+ million will specifically go toward establishing a new manufacturing site in the United States. The new facility is intended to complement the manufacturing capabilities of their Uppsala, Sweden, plant. No final location has been announced at this time.

Of the remaining sum, $400 million is going toward cell culture media; $300 million toward single-use technologies; and $200 million toward continuing expansion work in various countries.

This investment is the latest in a series of expansion moves made by the companies. In September 2020, Cytiva pledged $500 million over the course of five years on global manufacturing efforts. Since that announcement, Cytiva has already used the money to build a new manufacturing facility in Shrewsbury, Mass., and a new cleanroom in Westborough, Mass.

Additionally, since the September 2020 announcement Cytiva acquired companies such as Vanrx Pharmasystems, GoSilico, and Intermountain Life Sciences. In the same timeframe, Pall acquired Austar and Precision NanoSystems. Pall also announced plans to build a new plant in South Carolina and struck a manufacturing deal with Exothera.

Over the past year, Cytiva has hired 2000 new employees. With these plans in mind, the company is anticipating hiring 2000 more over the course of the next two years.

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Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.

Cytiva and Pall Investing $1.5 Billion into Manufacturing Expansion

The ZenoTOF 7600 System, recently launched by Sciex in June 2021, is a mass liquid chromatography–mass spectrometry/mass spectrometry (LC–MS/MS) instrument that includes both Zeno trap and electron activated dissociation (EAD) fragmentation.

This new system enables scientists to better identify, characterize, and quantify molecules by generating data that has been previously unattainable, Sciex stated in a company press release. These capabilities are expected to help solve real analytical challenges and advance the development of new precision diagnostics and biotherapeutics.

Zeno trap pulsing delivers up to twenty times more sensitivity than traditional orthogonal time-of-flight technology, while EAD fragmentation can derive novel structural information from diverse compound types. With EAD fragmentation, the system can fully characterize individual lipids from a single spectrum, which can enable the discovery of novel lipid markers for cancer and inflammatory disease. EAD fragmentation also allows biopharma scientists to precisely detect and quantify protein glycosylation patterns and differentiate isomeric amino acids, which are both critical for ensuring that therapies are safe and do not produce adverse reactions.

Additionally, when compared to prior products, this new LC–MS/MS system can quantify up to 40% more proteins and analyze biobank samples five times faster, Sciex stated in the press release.

Sciex’s recently launched accurate mass instrument, the ZenoToff 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

Sciex’s New ZenoToff 7600 Mass Instrument System Offers Increased Analytical Precision

Merck, known as MSD outside the United States and Canada, announced on July 16, 2021 that FDA approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by 

) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (such as anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

 (pneumococcus) is bacteria that cause pneumococcal disease. Different strains of these bacteria are called serotypes. Invasive pneumococcal disease (IPD) occurs when the bacteria infect parts of the body that are usually free from germs. Approximately, 80% of adult IPD occurs in adults 50 years of age and older. Serotypes 3, 22F, and 33F significantly contribute to IPD, and serotype 3 is the leading cause of IPD in adults in the United States.

The approval of Vaxneuvance was based on data from seven randomized, double-blind clinical studies, which assessed safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses were not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes (assessed by opsonophagocytic activity geometric mean titers).

Immune responses for Vaxneuvance were superior to PCV13 for shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. However, randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and make recommendations on the use of Vaxneuvance in adults.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

In a July 19, 2021 press release, Meissa Vaccines announced that a single adjuvant-free dose of the company’s intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212, was equally effective against SARS-CoV-2 (compared to the efficacy of currently authorized vaccines), according to preclinical data in nonhuman primates (NHPs). The data also showed that MV-014-212 stimulated mucosal (nasal immunoglobulin A [IgA]) antibodies in the upper respiratory tract and systemic (serum neutralizing and binding IgG) antibodies.

A conventional live attenuated coronavirus vaccine strategy is not recommended for SARS-CoV-2 because coronaviruses are genetically unstable, according to the company press release. MV-014-212 was built using the company’s AttenuBlock platform, which produces a vaccine backbone that provides appropriate attenuation, genetic stability, and optimized immunity. Moreover, live attenuated vaccines are effective at lower dosages and scalable.

According to the press release, injected vaccines may reduce but not contain transmission of COVID-19. The live attenuated intranasal vaccine, on the other hand, has the potential to block transmission, prevent infections, and provide broad and long-lasting immunity, the company claims.

Meissa’s intranasal COVID-19 vaccine generated both mucosal and systemic antibodies in NHPs and was protective against wild-type SARS-CoV-2 challenge. The company also enrolled and dosed SARS-CoV-2 seronegative and seropositive adult participants in all dosage groups of a Phase I clinical trial of MV-014-212. Interim analysis of the trial data is expected later this year.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data

PerkinElmer has entered into an agreement on July 26, 2021 to acquire BioLegend, a global developer and manufacturer of antibodies and reagents used in biomedical research (cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation, and bioprocessing). The transaction is expected to close by the end of 2021 and is valued at $5.25 billion.

With this acquisition, PerkinElmer will offer solutions in areas such as cell and gene therapy discovery. The company will also move into new spaces like proteogenomics. BioLegend’s new headquarters in San Diego, Calif. will serve as PerkinElmer’s center for research reagent content development.

PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.

PerkinElmer to Acquire BioLegend in $5.25-Billion Deal

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, Moderna announced in a 

Moderna announced data from the ongoing Phase II/III study on June 10, 2021, which enrolled more than 3,500 participants ages 12–18 years in the United States. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group, and the study met its primary endpoint. The vaccine was generally well tolerated with a safety and tolerability profile consistent with the previous Phase III study in adults.

Most of the adverse events were mild or moderate in severity. Injection site pain was the most common local adverse event, while the most common systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia, and chills.

The European Commission will consider authorizing the use of the Moderna COVID-19 vaccine in adolescents younger than 12 years of age.

Moderna is also conducting the KidCOVE study, a Phase II/III study, of mRNA-1273 in children ages six months to 12 years.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents 

Sinovac Biotech’s Eupolio vaccine, which is a Sabin inactivated poliovirus vaccines (sIPV) developed by Intravacc and out licensed to Sinovac, has gained marketing authorization in China from the Chinese National Medical Products Administration (NMPA).

The approval, which was announced in a July 20, 2021 press release, is a positive result for the ongoing efforts to eradicate the globe of polio. Intravacc had originally developed the vaccine for the purpose of providing low- and middle-income countries with the opportunity to produce their own safe polio vaccine.

According to the company press release, many vaccination campaigns to eradicate polio were put on hold or delayed during the COVID-19 pandemic. So, the approval of the Eupolio vaccine in China will help to close the gap between the supply and demand of inactivated polio vaccines for infants.

“This is a great example project in which Intravacc’s innovation and knowledge have been the foundation of the development of an affordable vaccine that contributes to the reduction of infectious disease burden on a global level,” said Jan Groen, Intravacc’s CEO, in the press release. “We have recently launched a similar program for our Avacc 10 COVID-19 nasal spray vaccine, intending to make this vaccine available to the world.”

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

The European Commission (EC) has granted marketing authorization to bluebird bio for its gene therapy SKYSONA, which is a one-time therapy for the treatment of early cerebral adrenoleukodystrophy (CALD) in patients under 18 years old without matched sibling donor.

CALD is a rare, progressive, and irreversible neurodegenerative disease that involves the breakdown of myelin. SKYSONA is custom designed to treat the underlying cause of CALD with the goal of halting disease progression and preserving as much neurological function as possible. The gene therapy works via 

 transduction with the Lenti-D lentiviral vector to add the functional copies of the ABCD1 gene into the patient’s own hematopoietic stem cells.

The marketing authorization of SKYSONA was supported by clinical data that demonstrated the treatment had a durable effect on major functional disabilities-free survival. The therapy has been evaluated as part of the European Medicines Agency’s Priority Medicines scheme (PRIME) and had previously been granted orphan medicinal product status.

“SKYSONA is the first and only one-time gene therapy approved in the EU [European Union] for patients with CALD, a devastating neurodegenerative disease, and we are immensely grateful to all who have brought us to this milestone, from the patients and their loved ones, to all study investigators, regulators, the ALD community and, of course, the extended bluebird family,” said Andrew Obenshain, president, severe genetic diseases, bluebird bio, in a July 21, 2021 press release. “bluebird bio was founded with the mission of developing a therapy to recode CALD on the genetic level, and today’s announcement represents over twenty years of research and development that has laid the groundwork for future gene therapies to be possible.”

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD. 

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

Catalent has announced, in a July 21, 2021 press release, that it will start the first phase of a $100-million expansion program at its Italian facility in Anagni to increase its manufacturing capabilities for biologics drug substance.

This first phase of the expansion will involve the installation of two 2000-L single-use bioreactors in new, purpose-built manufacturing suites. Additionally, early phase clinical development and late-stage and commercial tech transfers will be supported through associated investments. Infrastructure for a further six 2000-L single-use bioreactors will also be created in the initial phase.

It is anticipated that the initial phase will be commissioned and operational for customer projects in April 2023. Later phases of the expansion program are set to provide 16,000 L of flexible manufacturing capacity, which will allow for 2000 L to 8000 L batch production scale.

“Catalent is committed to supporting customers from small and virtual biotechs to large biopharma companies that require the right capabilities, scale of capacity, and integrated solutions to meet their needs for new biologic therapies and vaccines,” said Mario Gargiulo, Catalent’s region president, Biologics, Europe, in the press release. “Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations.”

Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.

Catalent Invests $100 Million to Expand European Biologics Manufacturing Capabilities

 on July 20th that it has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

G-CON manufactures turnkey current good manufacturing practice (CGMP)-compliant suites called PODs. PODs are cleanrooms built offsite and differ from traditional structures due to their ease of scalability, mobility, and the ability to repurpose them after the completion of the production process.

"We are proud to partner with G-CON for the next, exciting chapter of its growth trajectory," says Marika Vitiä, director at Summa Equity, in a press release. "We strongly believe G-CON has the potential to significantly accelerate bioprocessing production timelines, to help biopharma manufacturers get to market earlier and fully meet their capacity requirements after launch. This is a vitally important element of the healthcare value chain, ensuring that more of society has access to the right healthcare when they need it."

Founded in 2009 in College Station, Texas, G-CON has sold more than 300 cleanrooms since its inception. Following the acquisition, Summa has stated their goal to support G-CON in expanding their local market while also establishing an overseas presence. The transaction was completed on July 15th.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider. 

Summa Equity Acquires Cleanroom Provider G-CON Manufacturing

On July 21, 2021, Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Biovac will utilize Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and feature more than 20 manufacturing facilities. They will receive drug substances from facilities in Europe.

Biovac’s Cape Town facility is expected to be incorporated into the vaccine supply chain by the end of 2021, while manufacturing of finished doses is slated to commence in 2022. Annual production will exceed 100 million finished doses once full operational capacity is reached. All doses be exclusively distributed within the 55 states of the African Union.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere,” said Albert Bourla, chairman and chief executive officer at Pfizer, in a 

. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill/finish, and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to over 100 countries and territories. They have also pledged to supply 500 million doses to the US Government at a not-for-profit price, which the US will in turn donate to COVAX 92 Advanced Market Commitment (AMC) countries.

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

On July 22, 2021, Catalent announced the launch of its next-generation cell-line development technology, GPEx Lightning, which combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.

The benefits of the GPEx cell line expression system include titers of up to 10 g/L for traditional monoclonal antibodies, with no need to test for genetic stability. The new GPEx Lightning platform combines multiple, advanced engineering technologies into a single process, which can provide high yielding cell lines while reducing development steps. This reduction in steps can potentially save six to 12 weeks of development timelines.

“Speed to clinic is of critical importance to our customers and the patients they serve, and GPEx Lightning builds on a proven platform to accomplish that goal,” said Mike Riley, region president, Biologics, North America, Catalent, in a company press release. “We continue to develop innovative offerings from cell line development through to CGMP [current good manufacturing practice] manufacturing to enable accelerated timelines with the highest level of rigor and quality.”

Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.

Featured Content

A Holistic Approach to Purification

Novavax Reports 90% Efficacy for Vaccine

Balancing Outsourcing Priorities

Technology Forum