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Contec announced on Jan. 19, 2020 that it has introduced ReFIBE sterile cleanroom wipes, sustainable polyester wipes made from recycled post-consumer plastic bottles.

According to a company press release, the plastic bottles are first chopped into flakes and cleaned, then the flakes are melted, filtered, and formed into chips, which are melted and made into yarn. Finally, the yarn is knitted into sterile and non-sterile 9” x 9” and 12” x 12” ReFIBE wipes.

Laser-cut with heat-sealed edges, ReFIBE are cleanroom laundered and made with 100% polyester, Contec said in the press release.

“ReFIBE has been such a fulfilling project to work on,” said Amy Russ, global project manager for the Cleanroom Division at Contec, in the press release. “We consider it our responsibility to offer clean, sustainable alternatives to our customers, and ReFIBE wipes are just the beginning. We are excited to develop more sustainable options for both existing Contec products and new innovations in the months and years to come.”

Articles

ReFIBE sterile cleanroom wipes are sustainable polyester wipes made from recycled post-consumer plastic bottles.

Contec Introduces Sustainable Cleanroom Wipes

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Although there was much analysis and anticipation over the past year about the difficulties and challenges in distributing millions of doses of new vaccines across the nation, the process so far has been much less effective than anticipated. Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

While the Trump administration’s Operation Warp Speed (OWS) deserves kudos for supporting the accelerated development and production of safe and effective anti-COVID vaccines in record time, its plan for distributing and administering the preventives has been marred by political infighting and conflicting messages. State health officials have complained loudly of the lack of resources to support a massive new vaccination program and on limited information from Washington on the timing and size of anticipated vaccine distributions. The initial roll-out to health care workers and nursing home residents were tricky to schedule and arrange, and federal vaccine prioritization guidelines proved cumbersome. Many states are moving on to include more elderly populations, acknowledging that efforts to target certain groups such as nursing homes, teachers, and other front-line workers have been confusing and wasteful.

A main problem was the administration’s delay in authorizing the Centers for Disease Control and Prevention (CDC) to provide states with clear guidelines for updating existing local procedures for distributing vaccines that critical “last mile” to clinics and health centers, a challenge familiar to supply-chain experts. Uncertainty about vaccine shipments and supplies, at a time when hospitals were dealing with surges in COVID-19 infections and deaths, prompted medical centers to cancel in-house vaccination activities. And there still is confusion about whether clinics should hold back supplies for second doses or administer all on hand.

Although vaccine manufacturing has been ramping up, and supply has not been blamed for current distribution failures, there remains concern about unanticipated production problems. In November 2020, Pfizer rattled OWS by disclosing that it would provide only 50 million doses in 2020, instead of the 100 million doses initially expected. And just last week, Pfizer announced plans to reduce vaccine supplies in Europe as it moved to renovate production processes at its Belgium facility. At one point in December, Moderna had to discard 400,000 vaccine doses due a filtration issue during production, although the company maintained that it would still produce its promised doses. Pfizer agreed recently to increase vaccine deliveries in the United States by another 100 million doses in 2021, but that is linked to access to certain supplies and raw materials needed for production. There is great hope that Johnson & Johnson will gain emergency authorization soon for its one-shot COVID vaccine, which would greatly bolster supplies of a product much easier to deliver, store, and administer.

Meanwhile, research is underway on strategies for extending the current vaccine supply. These include studies on whether smaller or less frequent doses of the Moderna vaccine provide sufficient protection. There’s a search for a certain kind of syringe that is able to extract an additional sixth dose from Pfizer five-dose vials. There also has been talk of delaying or dropping the second doses for current vaccines, but FDA officials oppose such an untested move.

Congress finally approved a $900 billion relief package in late December, which provides an additional $8 billion for state vaccine distribution and administration, and that is now beginning to trickle down to local operations. However, efforts by the Biden transition team to form a new vaccine distribution program were hampered by limited communication and information sharing by the Trump administration and OWS. In fact, current vaccine policy was further confused by the recent announcement by Health and Human Services (HHS) secretary Alex Azar that OWS would ship to states thousands of vaccine doses held in warehouses to provide second shots for patients, only to learn that there was little supply on hold to do this.

Meanwhile, President-elect Joe Biden released a

new initiative for ramping up vaccine distributio

n to meet the goal of administering 100 million doses to Americans in the next 100 days. The plan calls for mobilizing the National Guard and the Federal Emergency Management Agency to establish federal vaccination centers, while also working with pharmacies, community health centers, and mobile vaccination clinics to reach broader populations. There’s a promise of more support and resources for states and plans to ensure that all entities know well in advance and understand vaccine allocations and timing of deliveries, including an assurance of second-dose availability, in keeping with current FDA recommendations.

The plan acknowledges the need for added access to critical vaccine components, such as vials, syringes, stoppers, and needles, and may leverage the Defense Production Act to fill any gaps. And there’s support for boosting vaccine finish/fill and packaging operations, as well as for augmenting required cold chain systems needed for effective vaccine distribution and storage. The new administration furthermore backs efforts to “maximize the manufacture of vaccine,” but is vague on how to do this.

In looking to put a new stamp on its federal vaccine initiative, Biden named former FDA commissioner David Kessler to replace OWS leader Moncef Slaoui in directing continued development and production of vaccines and therapies to combat the pandemic. Kessler is best known for expanding FDA regulation of tobacco, establishing FDA user fees, and revising regulatory policies in the face of the AIDS epidemic. There is concern that he has little experience in vaccine research or distribution and has been away from federal health policy for the past 20 years. But now he will be key to the success of the new administration’s promise to vaccinate 1 million people a day to gain control of the pandemic and restore the nation’s health and economic well-being.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far. 

Vaccine Rollout Even Worse than Expected

CPhI Worldwide, organized by Informa Markets, announced on Jan. 15, 2021 that the CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue. The decision was made based on the hope that COVID-19 vaccine programs are fully advanced and that international travel is permitted.

“At CPhI Worldwide, we understand the importance of meeting face-to-face with your peers and potential business partners,” the CPhI Worldwide Team said in a press release. “The new dates will also hopefully ensure COVID-19 vaccination programs are well advanced, creating more certainty around international travel and ensuring the event is as successful as possible, delivering you the same opportunities and the experience you’ve come to expect from CPhI Worldwide.

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

CPhI Worldwide Moves to November 2021

Leukocare, a German biotechnology company, announced on Jan. 11, 2021 that it has officially launched its development laboratories and offices in Milford, MA.

According to a company press release, the new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team. The offices and laboratories are located on Rentschler Biopharma´s Milford premises, where the companies will continue to carry out their global strategic alliance that was established in 2017.

“I am delighted to announce the opening of Leukocare´s US site today,” said Michael Scholl, CEO at Leukocare, in the press release. “The company´s outstanding development over the last few years led to our desire of establishing a presence in the largest pharmaceuticals market worldwide. This strategic step enables us to be even closer to both our US and global customers and to better understand and serve their needs. Furthermore, the existing infrastructure of Rentschler in Milford—that we will partially make use of—allows us to start operations without any delay and, thus, makes Milford the perfect choice for our newly established US site. We therefore will continue to pursue our strategy of pushing boundaries of biopharmaceutical product development by combining innovative biostatistics, artificial intelligence, and vast formulation expertise with first-class analytics.”

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

Leukocare Opens Development Laboratories and Offices in Massachusetts 

Thermo Fisher Scientific announced on Jan. 15, 2021 that it has completed its acquisition of Henogen, Novasep’s viral vector manufacturing business in Belgium, for EUR 725 million (US$875 million) in cash.

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment, Thermo Fisher said in a company press release. The new business offers contract manufacturing services for vaccines and therapies to biotechnology companies and features 7000 m2 of clinical and commercial manufacturing capacity.

“Novasep’s viral vector business is an excellent strategic fit as Thermo Fisher continues to expand its capabilities for cell and gene vaccines and therapies globally,” said Michel Lagarde, executive vice-president of Thermo Fisher, in the press release. “The addition of their manufacturing capabilities in Europe complements our four development and manufacturing sites in North America. In addition, they bring an incredibly talented team with more than two decades of experience across a broad range of viral vectors. The combination will benefit our global customers seeking support and capacity in the region as well as European customers bringing new medicines to patients inside and outside of Europe.”

“Thermo Fisher is an outstanding partner for our viral vector business and its future development,” added Michel Spagnol, president and CEO of Novasep, in the press release. “Our diverse customer base will benefit from the combination of our viral vector services capabilities with the scale and capabilities of Thermo Fisher. Our talented employees will bring deep expertise to an organization that shares our commitment to providing ground-breaking new medicines to patients.”

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment.

Thermo Fisher Completes $875-Million Acquisition of Novasep’s Viral Vector Manufacturing Business

Fujifilm and The Massachusetts Center for Advanced Biological Innovation and Manufacturing announced on Jan. 14, 2021 that they are investing $76 million into a new manufacturing and innovation center in Watertown, MA.

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products, Fujifilm said in a company press release. The site will all also provide quality control, lab, office, and convening space for academia, industries, and hospitals.

Operations at the center will begin in early 2022.

“Fujifilm is pleased to partner with leading academia, industry, and teaching hospitals, to explore the application of genetically modified cell therapies, and bring new treatment options to the market,” said Takatoshi Ishikawa, senior executive vice-president and chief life science officer, Fujifilm, in the press release. “This collaboration supports our larger healthcare strategy to utilize the combined strength of the Fujifilm Group’s products and services to offer personalized life-altering treatment options to clinicians and their patients.”

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products.

Fujifilm to Establish New Manufacturing and Innovation Center in Massachusetts 

Roche confirmed on Jan. 12, 2021 that the US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have agreed to purchase additional supply of Regeneron Pharmaceuticals’ casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. The agreement is part of Operation Warp Speed.

Under this new agreement, the US government will purchase up to 1.25 million finished doses of the antibody cocktail by June 30, 2021. With Regeneron already supplying doses to treat approximately 300,000 people, the new agreement brings the total potential purchase to more than 1.5 million doses in the United States.

The efficacy and safety of casirivimab and imdevimab continue to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients. The trials include an open-label trial (RECOVERY) of hospitalized patients in the United Kingdom and a trial for the prevention of COVID-19 in household contacts of infected individuals. In addition, lower doses of casirivimab and imdevimab are being studied with the aim of increasing supply and offering the therapy to more patients. To date, nearly 15,000 people have participated in clinical trials for this antibody cocktail, Roche said in a company press release.

Roche is collaborating with Regeneron to increase global supply of the cocktail and aims to have more than 2 million treatment doses available annually. Regeneron is responsible for the development and distribution of the treatment in the US, and Roche is primarily responsible for the development and distribution outside the US; the company is actively working with governments outside of the US on potential supply agreements. If approved, the companies will support access in low- and lower-middle-income countries through drug donations that will be made in partnership with public health organizations.

The US government said it will provide the additional doses from this new agreement at no cost to patients, though healthcare facilities may charge fees related to administration. The government will also continue to coordinate allocation of the antibody cocktail to state and territorial health departments.

“We are doing all we can to lessen the impact of the ongoing COVID-19 pandemic, and we remain committed to collaborating with Regeneron to increase supply of their antibody cocktail,” said Bill Anderson, CEO of Roche Pharmaceuticals, in the company press release. "Casirivimab and imdevimab will be critically important to help address the pandemic if approved, and we will continue to work with regulators and governments across the globe to bring the medicine to as many people as possible.”

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

US Government to Purchase Additional Doses of Regeneron’s COVID-19 Antibody Cocktail

On Jan. 12, 2021, Boehringer Ingelheim and Enara Bio, a science-led company targeting the T-cell/cancer-cell interface for the development of cancer immunotherapies, announced that they have entered into a strategic collaboration and licensing agreement in which they will research and develop novel targeted cancer immunotherapies. The collaboration will leverage Enara Bio’s Dark Antigen discovery platform.

Under the agreement, Boehringer Ingelheim has the option to license Dark Antigens discovered and validated by Enara Bio and will be responsible for all non-clinical and clinical development. Boehringer Ingelheim will also be responsible for the commercialization of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics. Meanwhile, Enara Bio will retain rights to use any discovered antigens in cell therapy-based products and is eligible to receive an upfront payment, together with research/preclinical milestones and licensing fees for each tumor type that is explored. Enara Bio is also eligible to receive more than EUR 876 million (US$1.06 billion) in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

Under the collaboration, Boehringer Ingelheim will combine its approach to developing cancer therapeutics with Enara Bio’s expertise in identifying cancer antigens, with the aim being to provide potential new therapies for difficult-to-treat lung and gastrointestinal cancers.

Dark Antigens represent a new class of cancer-associated antigens. These antigens are derived from genomic dark matter, or the portion of the human genome that is normally not expressed as protein, the companies explained in a press release. Dark Antigen-encoding sequences, which are usually silenced in healthy cells but are activated and presented on tumor cells, are associated with specific cancer types. In addition, these sequences are shared across patients, according to the companies. Because Dark Antigens are not typically visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies, the companies stated in the press release.

Through the collaboration, Enara Bio’s proprietary Dark Antigen Platform Technology (EDAPT) will be used to discover and validate novel Dark Antigens in up to three tumor types in the lung and gastrointestinal cancer space. The discovery of shared antigens could lead to the development of vaccines that can have an impact on a broader group of cancer patients.

“We are excited to partner with Enara Bio as part of our mission to bring transformative new treatments to cancer patients,” said Jonathon Sedgwick, PhD, senior vice-president and global head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim, in the press release. “We are advancing a unique pipeline of cancer cell-directed agents, immuno-oncology therapies, and intelligent combination approaches to help combat cancer. Enara Bio’s unique discovery platform offers a novel and highly differentiated approach that will allow us to look beyond the known proteome to identify and characterize Dark Antigens to support the development of T-[c]ell [r]eceptor (TCR)-directed immunotherapies and therapeutic vaccines. We believe this is a highly innovative and promising approach to the development of the next wave of cancer immunotherapies.”

“We are extremely pleased to enter this strategic licensing agreement, our first major deal leveraging our pioneering Dark Antigen discovery and validation capabilities,” added Kevin Pojasek, president and CEO of Enara Bio, in the press release. “Boehringer Ingelheim is an innovation-led company dedicated to producing breakthrough treatments with a significant focus on cancer. We are excited to build this relationship and are encouraged that Boehringer Ingelheim shares our view of the potential of Dark Antigens to be a source of important and unconventional targets for novel cancer immunotherapies. This agreement provides strong validation for our science and our approach to exploiting the cancer-associated antigenic repertoire derived from genomic dark matter and we look forward to a productive collaboration.”

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

Boehringer Ingelheim and Enara Bio Partner on Cancer Immunotherapies

Pfizer announced on Jan. 12, 2021 that, during the second half of 2020, it invested a total of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Through this initiative, Pfizer is investing up to $500 million in biotechnology companies in an effort to provide funding and access to the company’s scientific expertise. The aim is to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer.

$10 million in Vancouver, BC-based ESSA Pharma, a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.

$25 million in Cambridge, MA-based Trillium Therapeutics, a clinical-stage immuno-oncology company focused on developing innovative therapies for the treatment of cancer. Jeff Settleman, senior vice-president and chief scientific officer of Pfizer’s Oncology Research & Development Group, was also named to Trillium’s scientific advisory board.

$25 million in Cambridge, MA-based Vedanta Biosciences, a privately held clinical-stage company focused on developing a new category of therapies for immune-mediated diseases. The company’s work is based on a rationally defined consortia of human microbiome-derived bacteria. Michael Vincent, senior vice-president and chief scientific officer of Pfizer’s Inflammation & Immunology Research Unit, will join Vedanta’s scientific advisory board.

$60 million in Bedford, MA-based Homology Medicines, a clinical-stage genetic medicines company specializing in treatments for rare genetic diseases with significant unmet medical needs. Seng Cheng, senior vice-president and chief scientific officer of Pfizer’s Rare Disease Research Unit, has joined Homology’s scientific advisory board. He will handle matters related to Homology’s gene therapy and gene editing programs for phenylketonuria (PKU).

“Pfizer has a long history of collaborating across the healthcare ecosystem with the shared goal of turning great science into innovative new medicines,” said Debbie Baron, senior vice-president of Business Development, Pfizer, in a company press release. “Our investments in Homology, Vedanta, Trillium, and ESSA reflect our commitment to find new and creative ways to leverage Pfizer’s resources to deliver breakthroughs to patients.”

The first four investments of the new program will support clinical-stage biotechnology companies while new investments will include companies focused on oncology, rare disease, and inflammation and immunology.

Pfizer Invests $120 Million in Biotechnology Innovation

On Jan. 14, 2021, Precision Medicine Group (PMG) announced that it has acquired Project Farma, a patient-focused bioengineering services firm focused on supporting life science innovators in the manufacturing and scale-up of advanced therapies. The acquisition significantly expands PMG’s expertise in cell and gene therapy.

Through the acquisition, Project Farma will be part of Precision for Medicine, PMG’s research and development services arm. Project Farma has expertise in planning and implementing complex biomanufacturing strategies and facilities for clients, ranging from start-up biotechnology companies to global biopharmaceutical companies and academic medical centers, PMG said in a company press release. Project Farma has led more than a dozen manufacturing facility builds with capital investments greater than $1 billion.

“In today’s highly competitive and scrutinized advanced therapies marketplace, ensuring a safe, scalable, and high-quality manufacturing capability can be the difference between success and failure. Project Farma are the experts at defining and developing the optimal manufacturing strategy and leading implementation of a customized solution. This essential capability is now expanded and leveraged by the comprehensive cell and gene therapy services available through Precision ADVANCE,” said Precision for Medicine’s President, Chad Clark, in the company press release.

“Since 2013, Precision has supported over 70% of [FDA]-approved cell and gene therapies and is now even better positioned to support the hundreds of therapeutic new entrants coming to market. With our acquisition of Project Farma, Precision is the only life-science services company with true end-to-end capabilities in cell and gene therapy,” said Mark Clein, CEO of Precision Medicine Group, in the press release.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

Featured Content

Can Pharma Quality Go High Tech?

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More than 50 New Drug Approvals in 2020