Pharmaceutical Technology Editors

FDA announced on Oct. 12, 2022 that it would be amending its emergency use authorizations for the Moderna and Pfizer-BioNTech bivalent booster to permit their use in children as young as five years old. While the Pfizer vaccine is authorized for use in children as young as five, the Moderna vaccine is only permitted for children ages six and older.

According to an agency press release, FDA based its decision on immune response and safety data from a clinical study in adults whom received a bivalent COVID-19 vaccine, containing both the original strain and the BA.1 omicron variant. (FDA considers BA.1 as relevant and supportive of vaccines containing components of the BA.4 and BA.5 variants.) The bivalent boosters contain a protein in common between BA.4 and BA.5 to add protection against the omicron variant.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, director, Center for Biologics Evaluation and Research, FDA, in an agency press release. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

In addition to this authorization, the amendment now restricts the use of the monovalent boosters in children aged 6 to 11 years old. Both vaccines remain authorized as a primary series for individuals six months and older.

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FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older

Spectrum Chemical, a provider of fine chemicals, laboratory equipment, and supplies, recently announced the promotion of Russell Kneipp to the positions of president and CEO. Kneipp, who has served as COO for Spectrum Chemical since 2018, will assume these roles effective immediately.

“Russell has done a remarkable job making sustainable improvements in our operations, product portfolio, QC testing capabilities, and global infrastructure, as well as preparing Spectrum Chemical for the future,” said Paul Burg, founder and co-chairman, Spectrum Chemical, in a company press release. “With his proven track record guiding high-performing teams like ours, I have full confidence that he will take Spectrum Chemical to even greater heights.”

According to a press release from Sept. 28, 2022, Kneipp has worked in leadership positions in various industries, including chemicals, industrial manufacturing, automotive, aerospace, and medical devices. This includes senior roles with Honeywell International, Royal Truck Body, Industrial Parts Depot, and Storm Manufacturing Group.

“I am honored and very excited to accept this new opportunity and responsibility with Spectrum Chemical,” said Kneipp in the release. “Our products and services are highly respected throughout the world, and we have exceptionally talented and committed employees working diligently every day to maintain our customer-centric reputation. Together, we will move forward into the next level of business progress and continue to deliver the highest quality and value to our customers and partners.”

In addition to the appointment of Kneipp, Randy Burg has been named co-chairman after working in various leadership positions with the company for 40 years, including president and CEO. He will transition to this role in June 2023, where he will preside with Paul Burg.

Russell Kneipp, who has been Spectrum’s COO since 2018, will assume the roles effective immediately.

Spectrum Chemical Appoints Russell Kneipp as President and CEO

CRB, a life sciences consulting company, recently announced the release of the Horizons: Life Sciences report. The report, available as a free download on the CRB site, discusses various challenges facing manufacturers and how they can keep pace with rapid innovation.

According to a company press release from Sept. 27, 2022, the report features perspectives from approximately 500 industry leaders representing North American, European, and Multinational companies; primarily, they serve in R&D roles upstream of Good Manufacturing Practice manufacturing. The report’s eight chapters analyze various trends and their impact on submarkets, as well as survey data on what companies are doing to drive success. Topics of note include the importance of diversification, multimodal manufacturing, talent, and partnerships.

“While the COVID-19 pandemic taught us new lessons about the quick and safe delivery of critical vaccines, the learnings from that global shock are only now being understood,” writes Tim Barba, CRB’s COO for Global Technical Operations, CRB, in the report’s opening passages. “They guide our thinking about highly adaptable research and production environments. They inform our collaboration with industry and trade partners in the pursuit of cures. They even teach us to focus inward to make sure our researchers, support teams and staff have the right tools, technology, and high-level support required to get the job done.”

CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.

CRB Releases Trends and Insights Report

Schrödinger, a pharmaceutical company that utilizes a specialized computational platform for drug discovery, announced a collaboration with Eli Lilly and Company (Lilly) on Oct. 6, 2022. The collaboration is focused on discovering and optimizing small molecule compounds for a designated target.

According to a company press release, Schrödinger will be responsible for the discovery and optimization process, while Lilly will handle completion of preclinical development, clinical development, and commercialization. Schrödinger will receive an upfront payment and be eligible to receive up to $425 million, contingent on various discovery, development, and commercial milestone payments. Schrödinger will also be eligible to receive low single - to low double-digit royalties on net sales of any products emerging from the collaboration.

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Eli Lilly and Company will partner with Schrödinger to develop and optimize small molecule compounds.

Lilly and Schrödinger Ink $425 Million Small Molecule Partnership

Cytiva has acquired CEVEC Pharmaceuticals, a Germany-based provider of high-performance cell line development and viral vector manufacturing technologies, in a move that strengthens Cytiva's capabilities to offer biomanufacturing solutions.

With this acquisition, Cytiva gains CEVEC’s scalable producer cell lines for vectors based on adeno-associated virus and adenovirus, two widely used vectors for gene therapy delivery, according to an Oct. 6, 2022 company press release. Cytiva also gains producer cell lines (PCLs) enabled by CEVEC's ELEVECTA technology, which promotes yield, scalability, and robustness in the manufacturing process. The ELEVECTA technology provides all the components necessary for vector production integrated into the genome of the PCL, thus offering an alternative to technologies based on transfection or the use of a helper virus.

Under the agreement, CEVEC and its 46 scientific experts become part of Cytiva, effective immediately. CEVEC's products, services, and technologies will continue to carry the ELEVECTA and CAP brands in the immediate future and will be available to customers worldwide.

"[CEVEC's] innovative technology complements Cytiva's offering and brings the promise of improved viral vector manufacturing. With Cytiva's global reach and ability to scale, more customers will have access to [CEVEC's] technology and expertise to help accelerate and advance therapeutics for the benefit of patients," said Emmanuel Abate, president, Genomic Medicine at Cytiva, in the release.

"We are excited to become part of Cytiva. Combined with Cytiva's global presence and leading brands, this enables the whole gene therapy industry to embark on new and powerful solutions for scalable vector manufacturing and start a new era for therapies made available to patients in need," said Nicole Faust, CEO of CEVEC Pharmaceuticals, in the release.

Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.

Cytiva Acquires CEVEC, Boosts Cell Line Development Capabilities

Amphista Therapeutics, a biotechnology company focusing on drug discovery projects that use targeted protein degradation (TPD), announced on Oct. 6, 2022, that it had selected Domainex, a medicines research service partner, as a partner to provide integrated drug discovery services for its research programs. Domainex will provide Amphista with expertise in protein production, assay biology, and medicinal chemistry.

According to a company press release, Domainex has experience designing, synthesizing, and profiling targeted heterobifunctional protein degraders. Additionally, the company has established 

 binary and ternary complex formation assays to confirm target engagement.

“We are delighted to have been selected by Amphista Therapeutics to help them advance their portfolio of drug discovery projects, building on our previous collaboration,” said Tom Mander, CEO, Domainex, in the release. “Our skilled, multi-disciplinary, integrated team of medicinal chemists, cell biologists, biophysicists, and protein scientists will work closely with the scientific leadership team at Amphista to advance their cutting-edge protein degrading technology.”

“Amphista is expanding rapidly as we advance our growing internal TPD portfolio and our recently signed research collaborations with BMS and Merck Healthcare,” said Nicki Thompson, CEO, Amphista, in the release. “To support our planned growth, we’re also excited to expand our network of contract research collaborators and work with Domainex with their high-quality chemistry, assay biology, [and] biophysical expertise as we tap into the rich expertise in the Cambridge, UK, area.”

Amphista Therapeutics and Domainex will work together to develop treatments focusing on targeted protein degradation.