Pharmaceutical Technology Editors

Rentschler Biopharma and Vetter, two global contract development and manufacturing organizations, are unveiling a joint visualization of their strategic collaboration, Xpert Alliance. The collaboration is focused on delivering effective solutions to address clients’ changing and expanding needs in the biopharmaceutical industry.

Rentschler Biopharma and Vetter entered the alliance in mid-2020, aiming to allow clients to bring their complex products to patients in a faster and easier manner. The companies’ joint visualization 

 is focused on the advancement of the alliance and the visibility of the collaborative services the companies offer to clients.

“It is exciting to see how our alliance has been steadily evolving and taking shape,” said Dr. Frank Mathias, CEO of Rentschler Biopharma, in a press release. “We and Vetter have ambitious goals for our collaboration and believe that our clients can greatly benefit from the complementary services and seamless interactions we offer, with the ultimate aim of bringing new, life-changing treatment options to patients.”

“With joint projects ongoing, the day-to-day workings of our strategic alliance are running smoothly, as we work together to create best-in-class solutions for our clients from early development stage through to the market,” added Peter Soelkner, managing director if Vetter, in the release. “We are pleased with the progress we have made so far and look forward to demonstrating the added value we are generating through our collaboration.”
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Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.

Rentschler Biopharma and Vetter Unveil Xpert Alliance

Symbiosis, a contract manufacturing organization specializing in sterile global manufacture of pharmaceuticals, vaccines, and biopharmaceuticals, announced on March 30, 2022 the completion of the UK Research and Innovation project (UKRI). The collaborative project involved The Cell and Gene Therapy Catapult and Freeline Therapeutics and was funded by UKRI, costing £1.3 million (approximately US$1.7 million).

The project successfully developed and enhanced the manufacturing supply chain for the sterile filling and manufacturing process of drug product. The results of the project will now accelerate the manufacturing supply chain for advanced therapeutical medicinal products (ATMPs) in the United Kingdom.

The project established a streamlined manufacturing process and an improved contamination control process. The new processes can potentially save ATMP therapy developers a significant amount of time in the development phase by eliminating the need to test individual product efficacy and avoid disinfection issues of the facility post-manufacture.

“The aim of the project was to reduce the production cycle by up to 25%. Shortening timelines reduces storage costs and can increase manufacturing facility utilization,” commented John McCormick, COO of Symbiosis. “For many drug development projects, reducing manufacturing timelines, even by a few days, can facilitate these life changing medicines entering the clinic sooner.”

Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.

Symbiosis Successfully Completes UK Research and Innovation Project to Enhance Supply Chain for ATMPs

Thermo Fisher Scientific introduced a new large-volume electroporation system on March 16, 2022 that is intended to enable the development of cell therapies. The system’s goal is to allow cell therapy developers to move more easily from clinical development to commercial manufacturing.

The Gibco CTS Xenon Electroporation System features a closed, highly flexible design to facilitate gene modifications without the use of traditional viral vectors. According to a company press release, the electroporation approach enables the introduction of a payload into a cell by temporarily increasing cell permeability; this is done using an electrical pulse.

Unlike existing large-volume cell therapy electroporation solutions on the market, Thermo Fisher’s new system features programmable, flexible electroporation conditions and offers cell therapy developers full control to optimize a variety of hard-to-transfect cell types and payloads. The system can be used as a standalone technology, or it can be integrated with the Gibco CTS Rotea Counterflow Centrifugation System as part of a modular, closed, and automated cell therapy manufacturing workflow, according to Thermo Fisher.

The CTS Xenon Electroporation System can transfect up to 2.5e9 cells in 25 mL in a sterile system. This transfection capacity enables rapid and efficient non-viral transfection for clinical manufacturing applications. In addition, the system delivers up to 80% cell viability and 90% gene knockout transfection, allowing scale up from the small-volume Neon Transfection System without the need to re-optimize the electroporation parameters. Thus, the system is designed to easily transition from benchtop to clinic, according to the company.

“We launched the CTS Rotea System in 2020 as part of our strategy to deliver fit-for-purpose cell therapy solutions that can easily scale from development to commercialization. Adding the CTS Xenon Electroporation System to our end-to-end workflow will help customers overcome manufacturing challenges that hinder production, enabling them to bring life-saving therapies to patients faster,” said Amy Butler, president of biosciences, Thermo Fisher Scientific, in a company press release.

Thermo Fisher Scientific’s new Gibco CTS Xenon Electroporation System aims to provide easier scale up for cell therapies, from clinical development to commercial manufacturing.

Thermo Fisher Introduces New Electroporation System for Large-Scale Cell Therapy Development and Manufacturing

ATCC, a global biological materials management and standards organization, announced on March 28, 2022 that it has been awarded a two-year task order by the National Cancer Institute (NCI). Valued at $5.6 million, the task order is part of an existing indefinite delivery/indefinite quantity (IDIQ) contract that ATCC has with NCI. The IDIQ contract is for supporting the Division of Cancer Epidemiology and Genetics (DCEG) Molecular Epidemiology Assay Support (MEAS) program.

Under the contract, ATCC may coordinate receipt of specimens from clinical and field sites as well as process fresh samples within 24 hours. ATCC will also perform a broad range of molecular assays to characterize the models as required. ATCC may also provide support services for the procurement, storage, and shipment of specimens to and from international and domestic specimen sites as well as prepare specimens for transport to testing laboratories by aliquoting, labeling, and batching, as needed, according to a company press release.

DCEG’s mission is to discover the causes of cancer and research ways to prevent cancer by conducting transdisciplinary epidemiological and genetic research. DCEG investigators typically rely on contract services to provide technical support for specimen collection, receipt and processing, and assistance in identifying laboratories to perform state-of-the-art testing using high-quality biological specimens collected from clinical and field sites. The MEAS program provides support services for clinical studies on the genetic and other cellular events that influence the onset of different types of cancer.

"At ATCC, we are committed to supporting members of the clinical research community by providing them with the highest quality biomaterials for cancer research," said Raymond H. Cypess, chairman and CEO of ATCC, in the press release. "We know how important this is when they are designing studies to discover cancer's genetic and environmental determinants and innovative approaches to cancer prevention. Scientific research is critical for unlocking incredible breakthroughs in global health."

"Through our expertise in providing standard reagents, functional testing, and biorepository operations and management, ATCC continues to support cancer research through DCEG's clinical studies," said Joseph Leonelli, senior vice-president of ATCC Federal Solutions, in the press release. "We look forward to our continued relationship with NCI through the MEAS program."

Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.

NCI Awards ATCC Task Order to Provide Cancer Epidemiology Services to Research Community

KeyPlants, a Swedish provider of innovative life science facilities and PODs, announced on March 29, 2022 that it has shipped a first-of-its-kind vaccine manufacturing filling facility to Senegal in West Africa. The shipment of the facility was completed in less than eight months.

The facility will be the only regional manufacturing hub in Africa outside of South Africa that is capable of producing finished COVID-19 vaccines as well as other life-saving vaccines, according to the company. The facility is expected to become fully operational later in 2022.

The shipment of the facility is a step towards the materialization of Project MADIBA, led by Institut Pasteur de Dakar (IPD), a non-profit foundation focused on promoting public health in Senegal and throughout Africa. Project MADIBA has the capacity to produce up to 300 million COVID-19 vaccine doses annually, revolutionizing access to vaccines in Africa.

Project MADIBA has the ability to produce other therapeutics in addition to messenger RNA vaccines as well as align with the evolving needs of the local community due to the facility’s design. The facility’s portable and prefabricated design and multi-suite drug substance and fill/finish capabilities allow for a more sustainable and secure infrastructure of vaccine access.

“We are proud to leverage our extensive experience and expertise in modular facilities and off-site manufacturing to drive forward this important project,” said Jörgen Harrysson, CEO of KeyPlants, in a press release.“By doing so, we will help provide crucial access to lifesaving therapeutics for the African population.”

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.

KeyPlants Ships First-of-its-Kind Vaccine Manufacturing Facility to Africa

Sanofi and IGM Biosciences announced on March 29, 2022 the signing of an exclusive worldwide collaboration agreement focused on IgM antibody agonists against three oncology targets and three immunology/inflammation targets. IGM will receive $150 million upfront payments with the potential to reach more than $6 billion in development, regulatory, and commercial milestones.

Engineered IgM antibodies are part of a new group of potential therapeutics because of the possession of 10 binding sites compared to traditional igG antibodies which have only two. The superior features of IgM antibodies will be used to stimulate cell surface receptors and allow the companies to leverage ownership of a new antibody technology platform.

According to a press release, the details of the collaboration are as follows: “For each immunology/inflammation target collaboration program, IGM will lead research and development activities, and assume related costs, through the completion of Phase I clinical trial for up to two constructs directed to each immunology/inflammation target, after which Sanofi will be responsible for all future development and related costs, in exchange for up to $1065 million in aggregate development and regulatory and commercial milestones per immunology/inflammation target. Following the completion of Phase I clinical trial for each immunology/inflammation target, Sanofi will be responsible for subsequent development activities, commercialization efforts, and related costs. IGM is eligible to receive tiered high single-digit to low-teen royalties on global net sales.”

“Sanofi is a global leader in the development and commercialization of innovative therapies, and we welcome the addition of their extensive expertise and resources in expanding and accelerating the development of our IgM antibody platform across multiple areas of high unmet need,” said Fred Schwarzer, CEO of IGM Biosciences, in the release. “This partnership builds on an existing research collaboration with Sanofi and is a key step towards our goal of unlocking the full breadth of potential for this important new class of therapeutics. We are pleased to share this vision with Sanofi and look forward to working together on these six potentially first- and best-in-class programs.”

Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.