Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Automation Aids Cell and Gene Therapy Production

Despite many development challenges, stable producer cell lines show real promise.

State of Producer Cell Development for Lentiviral Vector Manufacturing

CPC presents a green alternative to chromatography that supports sustainable operations.

Exploring How CPC Progresses Green Chemistry Practices

Experts outline the benefits of single-use consumables relative to traditional approaches.

Weighing the Benefits of Single-Use Consumables

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Considerations for Analytical Testing for E&L

Suzanne Shelley is a contributing editor to 

Pharma Scientist Tracking Supply Chain Via DLT | ©leowolfert - Stock.adobe.com

Ongoing innovation in the biopharma pipeline continues to bring hope to patients and prescribers everywhere. Biologic molecules, however, are inherently fragile and thus are susceptible to deterioration in the face of excursions from the refrigerated, frozen, and ultra-frozen temperatures that are required throughout every step in the storage and transit process.

The universe of high-value biologics—which includes injectable specialty medications, cell and gene therapies (CGT), and other regenerative medicines and more—has come a long way over the past decade. Further complicating the picture, a growing number of innovative CGTs and other regenerative therapies call for the highly specialized collection and transport of not just extracted blood but extracted bone marrow, spinal fluid, and other tissue types, which are then used to produce engineered therapies that are used to repair, replace, or regenerate organs, cells, and metabolic processes in the body.

Protecting High-Value Biologics at Every Turn

BioPharm International’s Emerging Therapies 2023

The cold chain infrastructure that is needed to safeguard these products as they move from manufacturer to patients for infusion in a clinical setting or self-injection at home has also continued to evolve in terms of improved shipping container designs and insulation materials and state-of-the-art tracking and monitoring devices. At the same time, stakeholders are growing more comfortable using advanced data analytics capabilities (including artificial intelligence [AI] and machine learning [ML] techniques) and are pursuing strategic partnerships and geographically advantageous acquisitions to safeguard these critical time- and temperature-sensitive healthcare interventions.

BioPharm International's BioPharm International

 This article was previously published online July 12, 2023. 


Emerging Therapies 2023 eBook
September 2023
Pages: 24-30

When referring to this article, please cite it as Shelley, S. Protecting High-Value Biologics at Every Turn. 

Articles

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

Protecting Biologics at Every Turn

Apollo Therapeutics announced on Sept.6, 2023 the close of $226.5 million in a Series C financing led by lead investor Patient Square Capital, according to a press release.

“We are delighted to announce the close of our latest fundraise and wish to thank our existing investors for their continued support, as well as warmly welcoming all the new investors,” said Dr. Richard Mason, chief executive officer of Apollo Therapeutics, in a press release. “Apollo has built a broad and diversified pipeline focused on major commercial markets and this latest fund-raising enables us to take our most advanced programs to key clinical value inflection points.”

It was noted that there was participation by multiple new investors including M&G plc, in addition to two of the largest US public pension plans and the existing investor, Rock Springs Capital. Further, the financing significantly adds to the $195 million previously raised by the company, according to the press release.

The proceeds will be put toward the advancement of pipeline programs through clinical development and fund Apollo’s drug discovery and development activities based on breakthroughs in basic medical research made at its partner institutions. Apollo is a part of a research and development platform for the development of new medicines, with program selection being hesitant to indication and primarily driven by quality of science or the potential to transform the standard of care in major commercial markets, according to the press release. The current partner institutions include The University of Cambridge, Imperial College London, University College London, King’s College London, and The Institute of Cancer Research.

“I have long believed in a business model for drug development characterized by extremely talented management, sufficient capital to pursue multiple programs, and world-class science focused on unmet medical need. We are proud to support Apollo Therapeutics as it develops a number of promising medicines that we anticipate will eventually transform patient care,” said Jim Momtazee, managing partner of Patient Square Capital, and member of Apollo Therapeutic’s Board of Directors, in a press release.

Apollo is a part of a research and development platform for the development of new medicines, with program selection being hesitant to indication and primarily driven by quality of science or the potential to transform the standard of care in major commercial markets, according to the press release.

Apollo Therapeutics Closes $226.5 Million Series C Financing 

Andreas Dreps, PhD, is SVP, Drug Development Services at ICON

Martin Lachs, PhD, is VP, Project Management Oncology at ICON.

Ribosome translating mRNA into a polypeptide chain | ©Juan Gärtner - Stock.adobe.com

Cancer messenger RNA (mRNA) vaccines have made headlines multiple times in 2023. In February, an mRNA vaccine for cancer received breakthrough therapy designation after demonstrating efficacy in a Phase II trial (

). In May, the National Institutes of Health announced that in a small clinical trial, a personalized mRNA vaccine prevented pancreatic cancer from recurring for about half of trial participants (

). These developments were catalyzed in part by the success of the mRNA vaccine for COVID-19.

Logistical Considerations in mRNA Vaccine Development

Unlike traditional vaccines, the manufacturing process for mRNA vaccines is cell-free and can be performed with synthetic enzymes. This allows for unprecedented speed and scale of mRNA vaccine development and manufacturing, which proved to be pivotal during the COVID-19 pandemic. In turn, the deployment of mRNA COVID-19 vaccines helped forge the robust supply chain for mRNA vaccine manufacturing that had not previously existed. Despite this success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.

This article reviews the therapeutic prospects of mRNA vaccines and considerations for clinical development that could help address present issues with patient recruitment, regulatory compliance, manufacturing, and funding.

Andreas Dreps, PhD, is SVP, Drug Development Services at ICON; Martin Lachs, PhD, is VP, Project Management Oncology at ICON.


Emerging Therapies 2023 eBook
September 2023
Pages: 18-23

When referring to this article, please cite it as Dreps, A. and Lachs, M. Logistical Considerations in mRNA Vaccine Development. 

 Emerging Therapies eBook. September 2023.

Despite its success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.

Otsuka Pharmaceutical and ShapeTX announced on Sept.7, 2023 a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular diseases, with the possiblity to add additional targets and tissue types. According to the press release, the companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

The AAVid platform combines throughput screening of billions of unique AAV variants and machine learning to identify novel AAV capsids for direct-to-NHP 

 selection to maximize clinical translation. Further, according to the release, AAVid capsids are designed for precise target tropism while detuning for off-target biodistribution, which reduces the required dose and associated clinical safety risks. In addition, ShapeTXTX will apply the company’s transgene engineering technology to optimize payloads provided by Otsuka for therapeutic levels of gene expression in targeted cell types.

Under the new agreement, ShapeTXTX will receive an initial payment from Otsuka and is eligible to receive development, regulatory, and sales milestone payments that will potentially exceed $1.5 billion in aggregate value. ShapeTXTX is also eligible to receive tiered royalties on future sales of products resulting from the collaboration, according to the press release.

“We’ve built our AAVid platform on generative AI approaches akin to those behind Midjourney and DALL-E 2 to tackle industry challenges with gene therapy delivery,” said Francois Vigneault, PhD, co-founder and chief executive officer of ShapeTXTX, in a press release. “By incorporating diffusion models, our platform is designing novel medicines that transcend the boundaries of what is possible experimentally. Our collaboration with Otsuka marks an exciting chapter in our journey as we extend the reach and impact of our technologies to help as many patients as possible.”

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

Otsuka Collaborates with ShapeTX for Development of AAV Gene Therapies

Recipharm is partnering with Ahead Therapeutics, a Spanish start-up biotech company, to develop a ground-breaking treatment for a rare autoimmune disease, known as myasthenia gravis, using proprietary technology to develop treatments for different autoimmune disorders.

Ahead Therapeutics is known for the development of an innovative solution based on the use of PS-liposomes containing autoantigens, according to the press release. These liposomes can induce antigen-specific immune tolerance through a biomimetic process, thereby interrupting the autoimmune reaction. Further, the company’s newly developed solution for myasthenia gravis, which is intended for parenteral administration, is based on the use of phospholipid liposomes containing the antigen peptide. Through a biomimetic process, these liposomes can induce antigen-specific immune tolerance, which then interrupt the autoimmune reaction.

According to the press release, Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. Further, Recipharm also offers the capacity to scale up manufacturing and preparation for commercializing the therapy.

Myasthenia gravis is defined as a rare, autoimmune disease that most commonly affects the muscles controlling the eyes and eyelids, facial expressions, chewing, swallowing, and speaking. There are currently no cures, and treatments and chronic and symptomatic.

“Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform. Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases,” said Dr. Martí Dalmases Arnella, CEO of Ahead Therapeutics, in a press release. “This agreement represents a key milestone and the beginning of an exciting journey. Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project.”

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. 

Recipharm Partners with Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy 

Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced on Sept. 13, 2023 that it has received the cGMP Manufacturing Compliance Certificate following a successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at the UK site. According to the press release, the ATMP business was announced in early 2021 and the facility is in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, UK.

“MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV,” said Dr. Robert Panting, general manager of Rentschler’s ATMP business, in a press release. “We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.”

According to the press release, following the MHRA inspection, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

“Our contribution to improving the health and quality of life of seriously ill patients, is made possible by continuously expanding our expertise in the production of essential biopharmaceuticals. By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs,” said Dr. Christian Schetter, chief scientific officer of Rentschler Biopharma, in a press release. “It is gratifying to achieve this important milestone of MHRA approval, bringing us closer to reaching our objective of supporting clients already from the earliest stages of CMC development. We are continually looking to understand not only current client needs but future ones as well, which is how our ATMP offering came to fruition. We will continue to listen to our clients to anticipate how we can improve our offering and collaborate in advancing medicine to save lives, together.”

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Rentschler Biopharma ATMP Facility Receives MHRA Approval

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will also need to be more innovative to ensure commercially viable success is achieved (2).

An area that has witnessed significant breakthroughs over recent years has been that of cell and gene therapies. The market for these emerging therapies is projected to grow at a compound annual rate of 22.41% between 2022 and 2030 (3), driven by an expanding pipeline and increasing regulatory approvals.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. Aspects such as demand for accelerated development timelines, advancing technologies, and the growing issue surrounding sustainability are monopolizing the priorities of bio/pharma companies. However, through new opportunities, like allogeneic cell therapy, it is hoped that greater benefits to patients, particularly those in undertreated populations, will be achieved (4).

In speaking with Anis H. Khimani, PhD, senior strategy leader, Life Sciences Strategy Group at Revvity, 

 discussed with how new therapies are moving from their academic origins into industry.

Continued investment in cell and gene therapies

PharmTech: Is there anything specific you are seeing in terms of new emerging therapy development or manufacturing in the industry as of now?

Khimani (Revvity): Cell and gene therapies are delivering on the promise of curing diseases.Initially starting with CAR-T [chimeric antigen receptor T cells] treatments for hematological malignancies, therapies are now in the clinic for rare inherited genetic disease, infectious diseases, and solid tumors. Each of these therapeutic areas brings with it new technical and clinical challenges. From accurately targeting the diseased tissue, to ensuring that the corrected gene is expressing proteins at sufficient level to resolve the clinical symptoms, to ensuring that the products are robust, affordable, scalable, and accessible.

The more recent introduction of base editing offers the promise of more complex multiplexed editing with reduced off target editing and significantly lower indels and translocations. This approach is expected to reduce the time required to create therapies because editing can be performed concurrently instead of needing to be performed sequentially. Multiplex base editing has also been shown to have no impact on cell viability, so the yields will be unaffected. One example of base editing, the Pin-point™ system, has been demonstrated as able to knock-out immunogenic proteins and knock-in a targeted CAR within the same editing reaction, creating an effective functional CAR-T cell line with tumor-killing activity.

Addressing new short- and long-term challenges

PharmTech: Are there any new challenges or hurdles in the cell therapy space that should be addressed for the short- and long-term?

Khimani (Revvity): The production of cell therapies rely on accurate and safe editing without compromising the health of the cells being edited. To achieve this, there needs to be tight controls over cell isolation, editing, expansion, analysis, and delivery to the patient. The increasing number of processes being developed to address the cell therapy market will need to be consolidated at some point to create a standardized, scalable therapeutic approach. This will help to reduce manufacturing times and costs of treatment, and also create a framework for clinical trials and subsequent regulatory approvals, getting treatments to patients faster.

The benefits of utilizing allogeneic cell therapies

PharmTech: Why are companies starting to look at allogeneic cell therapies more closely?

Khimani (Revvity): Allogeneic therapies follow the traditional drug manufacturing process more closely than autologous cell therapies. The therapy can be scaled up so that the same product can be used to treat multiple patients, standardizing the product and reducing the cost per patient treated. As the tools used for gene editing to create allogeneic cell therapies continue to evolve and become more robust, it is imaginable that there will be an increasing interest and eventual preference for allogeneic cell therapies over autologous cell therapies.

Industry players and allogeneic therapies

PharmTech: Are allogeneic cell therapies a bigger opportunity for industry players, such as contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), and why?

Khimani (Revvity): Decentralizing manufacturing processes provides an opportunity for CDMOs and CROs to integrate into product pipelines. These industry players are already contributing their own expertise to accelerate allogeneic cell therapies, such as developing new analytical methods. As the cell therapy market continues to mature and CDMOs and CROs manage an increasing number of projects related to the development of this new generation of therapies, they will also mature their expertise, systems, and processes and grow their presence with the cell therapeutics industry. Cell therapies are rapidly evolving and are being developed to treat a broad array of disorders, so it is foreseeable that companies within the market will differentiate into having deeper expertise in a smaller number of specific therapies and/or areas of expertise over time.

PharmTech: What do you hope to see for the future of allogeneic cell therapies/any other emerging therapy development or manufacturing?

Khimani (Revvity): We hope that the combined learnings of this emerging and rapidly expanding class of therapies will see the acceleration of treatments and possibly cures for many devastating diseases. The first autologous cell therapy was approved in 2016, the first autologous CAR-T therapy was approved in 2017 and the first allogeneic stem cell therapy was approved in 2011, so we’re still at the starting line. Most promising, the development to approval timelines for cell therapies are trending faster than conventional therapeutics and the FDA has established a new, specialized office to process the increasing number of regulatory submission for cell and gene therapies.The current clinical trials address a broad range of conditions, including hematological malignancies, solid tumors, ocular conditions, infectious disease, autoimmune conditions, long COVID, inherited genetic diseases such as spinal muscular atrophy (SMA), severe combined immunodeficiency (SCID), neurological diseases including Parkinson Disease, depression, and diabetes. The breadth of indications continues to expand as we learn more about how to produce and administer cell and gene therapies, so it is an exciting era of medicine to be a part of.

Agrawal, G.; Keane H.; Prabhakaran, M.; Steinmann, M. The Pursuit of Excellence in New-Drug Development. McKinsey & Company, Nov. 1, 2019. https://www.mckinsey.com/industries/life-sciences/our-insights/the-pursuit-of-excellence-in-new-drug-development

McKinsey & Company. How AI Can Accelerate R&D for Cell and Gene Therapies. 

, Nov. 16, 2022. https://www.mckinsey.com/industries/life-sciences/our-insights/how-ai-can-accelerate-r-and-d-for-cell-and-gene-therapies

Cell and Gene Therapy Market (by Therapy Type: Cell Therapy and Gene Therapy; by Indication: Cardiovascular Disease, Cancer, Genetic Disorders, Infectious Diseases, Neurological Disorders; by Delivery Method: In-Vivo and Ex-vivo; by End-Users: Hospitals, Cancer Care Centers, Wound Care Centers, Others)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2022–2030

Fontanillo, M.; Paulick, K.; Poda, P.; Silberzahn, T. Out of the Shadows: A Brighter Future for Pharma Technical Development. McKinsey & Company, Sept. 16, 

. https://www.mckinsey.com/industries/life-sciences/our-insights/out-of-the-shadows-a-brighter-future-for-pharma-technical-development.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. 

Handling New Therapies Moving Through Drug Development at a Rapid Pace

Nurix Therapeutics announced on Sept. 7, 2023 that it has entered a multi-year, multi-target strategic collaboration agreement with Seagen, to further advance a new class of medicines, called degrader-antibody conjugates (DAC), for use in cancer treatment. According to the press release, the collaboration between the two companies will focus on an innovative approach to combine two powerful technologies to target cancer, antibody-drug conjugation (ADC) and targeted protein degradation (TPD), with the intention of creating drugs with new mechanisms of action, improved specificity, and anti-cancer activity.

“By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, MD, PhD, president and chief executive officer of Nurix, in a press release. “With Seagen, our strategic goal is to advance ADC technology to the next level to provide patients with new DAC drugs that deliver greater anti-tumor efficacy and safety compared to currently available agents.”

According to the agreement terms, Nurix will receive an upfront payment of $60 million and the potential to receive up to approximately $3.4 billion in research, development, regulatory, and commercial milestone payments across multiple programs. Further, as a part of the multi-year collaboration, Nurix will use its proprietary DELigase platform to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are fitting for antibody conjugation. According to the press release, Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

“The targeted protein degrader modality provides unique advantages over payloads currently employed across the ADC field,” said Gwenn M. Hansen, PhD, chief scientific officer of Nurix, in a press release. “This collaboration is a new application of our DELigase technology, and we are delighted to work with Seagen, a pioneer in the development and commercialization of ADC therapeutics, to create a new generation of drugs to fight cancer.”

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Nurix Announces Strategic Collaboration with Seagen

On Sept. 6, 2023, Charles River Laboratories International and PathoQuest announced the publication of the results of a seminal study in 

, which demonstrated the proprietary, good manufacturing practice (GMP) grade, next-generation sequencing (NGS)-based assay from PathoQuest had a greater capability of detecting viral contaminants when compared to 

The objective of the study was to compare classical 

 testing methods used to screen cell lines for adventitious viruses with a GMP-compliant viral transcriptome NGS assay. Further, the study was conducted as a head-to-head comparison of standard 

testing and NGS-based testing of cell substrates.

According to the press release, the team of Charles River experts prepared test materials and ran the 

 assays, while PathoQuest’s team tested the material with their proprietary NGS-based assay. There were cells infected with a wide variety of viruses reflective of the diversity and various patterns of virus-cell interactions in a real-world setting for biologics to determine the range of detection. Additionally, the infected cells were increasingly mixed with uninfected cells to further assess the analytical sensitivity and analyzed across several conventional 

 tests and with the NGS-based transcriptomic assay.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to 

 adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

“Our study demonstrates that PathoQuest’s unique NGS assay significantly increases the capability of detecting viral contaminations in cell substrates like cell banks, the starting material for biologics production, and in bioreactors during biologics production. The test has been validated to GMP standards and provides the pharmaceutical industry a faster, more efficient, and reliable testing option compared to animal-based testing,” said Professor Marc Eloit, DVM, PhD, head of the Pathogen Discovery Laboratory at the Institute Pasteur and Founder of PathoQuest, in a press release.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Charles River and PathoQuest Publish Study Validating Proprietary Next-Generation Sequencing Viral Safety Assay 

Orano Med and Orbit Discovery announced on Sept. 11, 2023 that they have entered a collaboration to discover specific peptide receptor radionuclide therapies against cancer cells and advance the development of novel radiopharmaceuticals. According to the press release, the agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

“We’re delighted to continue expanding our existing portfolio of partners by collaborating with Orano Med who have a strong track record of discovering novel radiopharmaceuticals,” Neil Butt, chief executive officer, Orbit Discovery, said in a press release. “We’re very proud of our proprietary screening platform at Orbit and acknowledge its role in empowering the next wave of peptide therapeutics.”

Radioligand therapies rely on the concept of combining the ability of biological molecules, like peptides, to target cancer cells with the short-range cell-killing capabilities of radioisotopes. According to the release, the approach results in an increased cytotoxic potential toward cancer cells while still limiting toxicity to nearby healthy cells.

This collaboration will strengthen the capabilities of Orbit’s peptide display engine to identify peptide candidates specific to tumor-associated targets, and the technology enables the screening of large peptide collections through the combination of DNA encoded libraries and bead-based presentation, according to the press release.

“Since the inception of Orano Med, we have recognized the value of collaboration,” said Julien Dodet, chief executive officer, Orano Med, in a press release. “In our strategy to develop and deliver 212Pb Targeted Alpha Therapy for cancer patients, we’re delighted to work with Orbit Discovery and leverage its technology and expertise in peptide ligand discovery to build our pipeline of radiotherapies.”

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Orano Med and Orbit Discovery Enter Collaboration for New Novel Targeted Radioligand Therapies 

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

FDA announced on Aug 30, 2023, that it is creating two compliance policy guidances initiating a year-long stabilization period for those in the pharmaceutical supply chain that need time to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The policy effects trading partners, mainly manufacturers, wholesale distributors, dispensers, and repackagers. The requirements are scheduled to change on November 27, 2023, and the stabilization period lasts until November 27, 2024.

The DSCSA went into effect in 2013, and outlines the requirements for the electronic tracing and identification of prescription drug distribution in the U.S. It requires trading partners to supply, accept, and maintain documentation on prescription drugs and their chain of ownership in the U.S. supply chain, from manufacturer to dispenser. The current DSCSA requirements as of September 1, 2023, will be changed on November 27, 2023. The new requirements will include mandating that trading partners manage documentation of product and ownership electronically (previously, partners were permitted to do so in paper format).

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product —Compliance Policies

 Revision 1 (WDVRS). WDVRS Revision 1 adds a year extension (from November 27, 2023, to November 27, 2024) to a guidance released on October of 2020 that directs distributors to verify product identifiers before distribution. EDDSR covers FDA’s new compliance policies for product tracing at the interoperable, electronic, package level; these policies will go into effect on November 27, 2023.

FDA intends for trading partners to use the stabilization period to “build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients.” It is not intended as a justification for delaying compliance efforts with the DSCSA.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies

Feliza Mirasol is the science editor for 

The opening of a new solutions center in Bengaluru, India, by Illumina, a US-based company specializing in DNA sequencing and array-based technologies, in August 2023 not only expands Illumina’s capabilities in genomics, but also expands access to genomics in that country.

The new center houses a fully equipped laboratory with the latest next-generation sequencing and array technologies. It is also fully resourced with field applications and service engineers that can offer broad genomics capabilities. The center will also provide training and education to increase technical expertise and access to genomics locally.

The new center is a permanent facility on the ground in Bengaluru for Illumina, which has spent the past 16 years working in partnership with Premas Life Sciences, an India-based contract research organization and provider of niche technologies in genomics, cell biology, and biopharma. With the help of the new solutions center, Illumina will continue collaborative work with Premas to grow the genomics market in India, according to an Aug. 17, 2023 company press release.

"Expanding Illumina's presence in India allows the company to collaborate and be part of a vibrant biotech ecosystem with skilled labor, strong research and development resources, and supportive government policies," said Gretchen Weightman, senior vice-president, Asia Pacific, Middle East & Africa, Illumina, in the company press release. "In our 25th anniversary year, it's a very exciting time to be growing our physical presence in India to drive access and the further adoption of genomics to transform human health, particularly in oncology and infectious disease."

Illumina’s business in India is led by Abhishek Gupta, country manager, and, according to Weightman in the press release, "Abhishek brings vast knowledge and experience to Illumina India, and we look forward to supporting him and the team as they collaborate with and support our customers." said Weightman.

The new solutions center also presents the opportunity to pursue equitable access and more diverse data in India. "Democratizing genomics and making it available to the many and not just the few will take a collaborative approach. We must better reflect diversity in genomic data and drive awareness for, access to, and adoption of genomic technologies, through partnership," Weightman said in the release.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Featured Content

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State of Producer Cell Development for Lentiviral Vector Manufacturing

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Weighing the Benefits of Single-Use Consumables

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