Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

AstraZeneca announced on May 20, 2024 that it is planning a new $1.5 billion antibody drug conjugate (ADC) facility in Singapore. The new facility is supported by the Singapore Economic Development Board (EDB) and will be the company’s first end-to-end ADC production site. ADCs deliver highly potent cancer-killing agents directly to cancer cells and require multiple process steps, including antibody production, drug and linker synthesis, conjugation of the drug-linker to the antibody, and filling of the completed ADC. Among its drug candidates, AstraZeneca has six wholly owned ADCs in the clinic and others in preclinical development.

“AstraZeneca has built an industry-leading portfolio of cancer medicines including antibody drug conjugates which have shown enormous potential to replace traditional chemotherapy for patients across many settings,” said Pascal Soriot, chief executive officer of AstraZeneca, in a press release (1). “Singapore is one of the world’s most attractive countries for investment given its reputation for excellence in complex manufacturing, and I am excited for AstraZeneca to locate our $1.5 billion ADC manufacturing facility in the country.”

"We welcome AstraZeneca's decision to establish a manufacturing presence in Singapore for the first time. It will also be a first for AstraZeneca—an end-to-end manufacturing facility for novel antibody drug conjugates that enables precision therapy for cancer,” said Png Cheong Boon, chairman, EDB, in the release. “This greenfield investment is a strong show of confidence in Singapore's biopharmaceutical manufacturing capabilities and talent, strengthens our ecosystem in supporting the development and manufacturing of precision medicines, and creates meaningful jobs and economic opportunities for Singapore. We look forward to a successful partnership with AstraZeneca."

AstraZeneca will work with the Singapore's government and other partners on sustainability solutions for the new ADC facility. The company plans for the facility to have zero carbon emissions. Construction on the new facility will begin at the end of 2024 with a target of 2029 for full operation.

In an email commenting on AstraZeneca’s Singapore investment (2), 

, managing director and head of European Healthcare at Houlihan Lokey, said:

“With a wide portfolio of in-house [a]ntibody-[d]rug [c]onjugates (ADCs) at various stages of clinical and pre-clinical development, AstraZeneca’s plan to build a new facility by 2029 exemplifies the long-term strategic thinking of large-cap pharmaceutical companies aiming to control their supply chains more effectively. This move reflects the industry's recognition of the complexities and costs associated with developing and manufacturing ADCs, which necessitates substantial investment in infrastructure to ensure quality and efficiency in production.

“The construction of this facility also highlights a broader trend within the pharmaceutical industry, where strategic initiatives are being directed towards high-growth market segments. ADCs, for instance, represent a significant opportunity with an estimated market size of $10 billion, growing at a rate exceeding 15% annually, driven largely by their promising applications in oncology. By investing in dedicated facilities, companies are positioning themselves to capitalize on this rapid growth and technological advancement.

“The strategic significance of ADCs in the pharmaceutical industry is underscored by other recent high-profile acquisitions. 

AbbVie’s $10 billion acquisition of ImmunoGen

 was partly motivated by the latter's expertise in ADCs, particularly in the area of solid tumor oncology. Similarly, 

 for $43 billion significantly bolstered its oncology capabilities, integrating Seagen's pioneering ADC technology.

“These acquisitions illustrate how major pharmaceutical companies are significantly expanding their oncology portfolios and technological capabilities to maintain a competitive edge in the market. AstraZeneca in particular, stands out as a market leader in the increasingly competitive market for ADCs, with the development of the site in Singapore further cementing its position.”

1. AstraZeneca. AstraZeneca Plans $1.5 Billion Manufacturing Facility for Antibody Drug Conjugates (ADCs) in Singapore. Press Release. May 20, 2024.
2. Tomasic, P. Commenting on AstraZeneca Building a $1.5bn Manufacturing Site in Singapore. Email Distributed by Dynevor, S. Houlihan Lokey, May 20, 2024.

Articles

The new facility will be the company’s first to offer full manufacturing processing for antibody drug conjugates.

AstraZeneca Plans $1.5 Billion ADCs Facility in Singapore

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

The European Medicines Agency (EMA) announced on May 17, 2024 that its Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of medicines that contain 17-hydroxyprogesterone caproate (17-OHPC). Drugs that contain 17-OHPC are used to prevent premature birth or loss of pregnancy. Other authorized uses include treatment of gynecological and fertility disorders.

The recommendation comes after a PRAC review that found there is a possible “but unconfirmed” risk of cancer developing in people that were exposed to 17-OHPC in the womb. The review also found that 17-OHPC is not effective in preventing premature birth and may not be effective in other authorized uses.

“In view of the concern raised by the possible risk of cancer in people exposed to 17-OPHC in the womb, together with the data on the effectiveness of 17-OHPC in its authorized uses, the PRAC considered that the benefits of 17-OHPC do not outweigh its risks in any authorized use. The Committee is therefore recommending the suspension of the marketing authorizations for these medicines. Alternative treatment options are available,” EMA stated in a press release (1).

PRAC will develop direct healthcare professional communication (DHPC) for 17-OPHC medicines that recommends use of alternative treatment options. Once approved, the DHPC will be provided to healthcare professionals by the marketing authorization holder.

Results from a large population-based study that looked at the risk of cancer in those exposed to 17-OHPC in the womb was used to make PRAC’s decision. While data suggested there was an increased risk of cancer compared to people not exposed to these medications, the study had limitations, according to PRAC. “The Committee therefore concluded that the risk of cancer in people exposed to 17-OHPC in the womb is possible but cannot be confirmed due to uncertainties” (2). PRAC also considered effectiveness data of other authorized uses of these medicines in a study of more than 1700 pregnant women with a history of preterm delivery. PRAC found 17-OHPC to be no more effective than placebo in preventing recurrent premature birth or medical complications.

In April 2023, FDA withdrew the approval of Makena (hydroxyprogesterone caproate injection) after post-marketing data found that the drug was not effective and there were risks associated with its use. Makena had been originally approved under FDA’s accelerated approval pathway in 2011 (3).

“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” said FDA Commissioner Robert M. Califf in a press release at the time of the withdrawal (3). “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”

“We acknowledge at the outset the serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women,” said FDA Chief Scientist Namandjé Bumpus in the release. “Nothing in this opinion today is intended to minimize these concerns—to the contrary, our hope is that this decision will help galvanize further research.”

EMA. Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024. Press Release. May 17, 2024.

EMA. Hydroxyprogesterone Caproate-containing Medicinal Products–Referral. 

FDA. FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena. Press Release. April 6, 2023.

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

Feliza Mirasol is the science editor for 

Regeneron’s Bari Kowal gave insight into how the biopharma industry views the application of AI in R&D.

Exploring the use of AI in R&D at the US Pharma and Biotech Summit

® at the US Pharma and Biotech Summit, Regeneron's Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, talked about the implementation of artificial intelligence (AI) in the R&D space. For example. Regeneron, Kowal explained, has been using AI for quite some time. Though not a new technology, she observed, AI has allowed the company to leverage many large language models and advanced searches for the past few years. Because of this, the company has built up collections of data in different areas, such as in genomics, protein databases, or for operational uses, including patient populations, study-level data, information about investigators, and quality of documents, among others.

“[Much] of our work is crossing over multiple facets of the drug development lifecycle early on in the discovery space, looking at how we manufacture and improving those processes, but also really looking at how we execute trials and reach out to the patients create diversity in the populations,” Kowal said. “We utilize some of the genomic data for finding the targets and more personalized medicine. [There are many] ways that we're leveraging AI.”

However, she emphasizes that the real value of AI is the ability to use it for existing data, especially in the search for optimizing operational efficiency. “Looking in the future, how do we use this to help our decision making and really better predict molecules that will have a tremendous effect? The biggest benefit that I can see, at least today, is that operational efficiency. If we can streamline drug development, from start to finish, our mission is to bring important medicines to patients at the end of the day, and so the time it takes today for drugs to be developed is too long. It's not measured in years, it's measured in decades,” she remarked. “If we can go from the research space to the development space in [a] few years, that is so much better and more beneficial to the patients that are waiting for those treatments.”

While speaking on a panel at the summit about diverging schools of thought on how AI should be used in R&D, Kowal observed that there were not necessarily divergent views by the panelists on how to use AI, but rather that the panelists had like-minded views on the topic. “I think we all believe that AI can be transformative. I think we believe that, ultimately, we're scratching the surface of what AI can do, but we also understand the human component and the context of human intelligence that you have to apply,” she stated.

 occurred on May 16, 2024 in New York, NY.

Videos

Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, Regeneron, discussed the utility of AI and how it can benefit R&D work.

A Discussion on Using AI in R&D at the US Pharma and Biotech Summit

Jeff Odum, CPIP, is practice lead, ATMPs & Biologics, at Genesis AEC.

Multimodal manufacturing is a strategic approach that harnesses the power of diverse manufacturing methods to optimize and streamline the production process, specifically within the realm of human therapeutics in the advanced therapy medicinal products (ATMP) space. This concept involves integrating different manufacturing techniques/platforms to improve efficiency, reduce costs, and enhance the overall quality of the manufacturing process and the eventual therapeutic product slated for licensure. 

Exploring Multimodal Biomanufacturing and Its Drivers

Pharmaceutical Technology’s Trends in Manufacturing

In a White House report, Bold Goals for US Biotechnology and Biomanufacturing, a prominent objective is to test and de-risk new biomanufacturing practices for next-generation biotechnology products in commercial manufacturing facilities (1). The growing focus in cell-based therapies, a key component of the next generation of human therapeutics, has led many organizations to focus their development efforts into a multitude of platforms.

Multimodal is not new. For the ATMP space, it was identified back in 2017 as a viable manufacturing option for clinical needs. In the context of the biotechnology ATMP space, multimodal manufacturing techniques are being applied to optimize the production of complex biological compounds and therapies that are studied in multi-omic research, such as gene editing (1).

In reality, many contract development and manufacturing organizations have been operating in a quasi-multimodal manner for decades. Multimodal can include vaccines, monoclonal antibodies (mAbs), viral vectors, plasmids, allogeneic cell therapies, and autologous cell therapies. The challenge is crafting a manufacturing plan that supports one’s business without attempting to become a one-size-fits-all solution for every need.

The forecasted growth of the cell and gene therapy (CGT) market is significant. The ATMP space, where CGT continues to serve as the primary catalyst for growth, is predicted to grow at a compound annual growth rate of 39.4% for the period from 2024 until 2030 (2).

In this growth projection, cell therapies account for 15% of the growth and gene therapies account for another 30% of growth, with many of these products advancing out of early-stage clinical manufacturing toward commercialization (2).

Just as the 1990’s large-molecule market saw a “fork-in-the-road” decision regarding single vs. multi-product manufacturing and the technologies to implement (3), the ATMP space is grappling with critical questions around asset size, cost, technology implementation, flexibility, scale, and many others. Transitioning to a multimodal manufacturing strategy could very well emerge as the most prudent business and operational solution.

Another key driver fueling the multimodal manufacturing discourse is the rapid pace of advancement in research, developing different modes of therapy to address multiple human therapeutic targets. Combination therapies using multiple therapeutic modalities have elevated anti-cancer activity while lowering doses of agents, thus reducing side effects (4). As previously referenced, gene editing tools such as clustered regularly interspaced palindromic repeats (CRISPR)-Cas, transcription activator-like effector nucleases (TALENs), and base editing have brought about multiple therapeutic solutions that are being provided for chronic diseases and oncolytic cancer treatments, as well as advanced chimeric antigen receptor T cell (CAR-T) and T-cell receptor (TCR) therapies.

Pharmaceutical Technology’s Trends in Manufacturing May 2024 eBook

1. The White House. Bold Goals for US Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. White House, Executive Order 14081, March 2023.
2. Vision Research Reports. Cell and Gene Therapy Market (By Therapy Type: Gene Therapy, Cell Therapy; By Application: Oncology, Genetic Disorders, Dermatology Disorders, Musculoskeletal Disorders, Others; End-Users: Hospitals, Cancer Care Centers, Wound Care Centers, Others)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2022-2030. Market Research Report, July 2022.
3. Witcher, M.F.; Carbonell, R.;Odum, J.; et al. Facility of the Future: Next Generation Biomanufacturing Forum Parts I, II, III. 

When referring to this article, please cite it as Odum, J. Exploring Multimodal Biomanufacturing and Its Drivers. 

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

Interview with Ken Keller, president and CEO, Daiichi Sankyo, at US Pharma and Biotech Summit

Ken Keller, CEO of Daiichi Sankyo sat with 

® at the US Pharma and Biotech Summit to discuss how to effectively create productive partnerships in the bio/pharmaceutical industry. He noted that a key component is for prospective partners to have a shared commitment to the therapeutic area that is the focus of a drug development program. “If it's strategically important to your partner, then it usually works out very, very well,” Keller said.

Relevant experience in the therapeutic area is also important. “Specifically, we work in oncology. So, if we're looking at a drug that has potential in breast cancer, we'll be looking for someone that's showing success in oncology in breast cancer very recently.”

Challenges involved in creating partnerships for developing therapies include creating a clinical data plan and committing to developing a stable supply chain going forward, Keller points out. “[A clinical data plan] is really the roadmap for whatever asset you have, that looks out five or 10 years, because sometimes it takes that long to complete the trials and the challenges, you've got to design them to deliver the evidence that not only prescribers will find attractive, but also payers.”

“I think it starts with the CEO and the C suite, doing something that only they can do. So as a leader, you've got to set the expectations for how bold you want that team to be,” says Keller. “The most important thing when two companies decide that they're going to do something together, is to really find a cohesive relationship, where you both believe that you can do more together than separately.”

Ken Keller, president and CEO, Daiichi Sankyo, discusses the foundation of partnership and takes a look at the future of biotech partnerships at the US Pharma and Biotech Summit.

A Look at the Future of Bio/Pharma Partnerships at the US Pharma and Biotech Summit

Melissa Green, head of global marketing for the healthcare division at TekniPlex, shares highlights from the company's presentation at INTERPHEX 2024. 

TekniPlex at INTERPHEX 2024: Advances in Materials Science

 sat down with Melissa Green, head of global marketing, healthcare division, at TekniPlex, to discuss the company's offerings and recent additions to its capabilities. 

TekniPlex is a global, integrated company that provides materials science and manufacturing technology solutions for healthcare, including the medical device, pharmaceutical, and diagnostics industries. 

During the show, TekniPlex demonstrated its expertise to support the burgeoning biologics market, including solutions for upstream and downstream processing and final fill operations, as well as single-use bioprocessing applications. 

“As the biologics sector continues its steady growth, so does the need for high-quality materials and components suppliers who can also be innovative solutions partners," said Chris Qualters, CEO of TekniPlex Healthcare, in a 

. “With our expanding capacities and innovative mindset, TekniPlex Healthcare is poised and ready to respond to the evolving needs of the sector, providing value-added solutions that help bring life-changing therapies to market.”

During the interview, Green also spoke to the advantages of the company's 

 in late 2023, which elevated the company to a full-service contract development manufacturing organization for medical materials science, specifically within the minimally invasive and interventional therapy devices space. 

Learn more about what TekniPlex has to offer by watching the video interview above. 

TekniPlex recently acquired Seisa Medical, which has expanded the company's services into that of a CDMO. 

How TekniPlex is Expanding to Support Innovative Solutions in Materials Science

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

IMA Life North America held a groundbreaking ceremony on May 8, 2024 for its new 80,000-square-foot facility in Tonawanda, NY. The facility is being built to increase production for the company’s freeze-drying equipment.

The Tonawanda facility is planned to open in September 2024 and will feature 50,000 square feet of production space and 30,000 square feet of office space on 15 acres. This new facility will supplement IMA Life’s current 60,000-square-foot facility in Tonawanda. New York State will provide up to $1,127,443 in performance-based Excelsior Jobs Program tax credits through the NY’s economic development agency, Empire State Development (ESD), in return for IMA’s commitment to job creation with an additional 70 employees. ESD promotes the creation of new job through the use of loans, grants, tax credits, and other financial assistance to enhance private business growth in New York State.

“New York is continuing to bring the companies, the investment, and the talent to build the future of medicine in our state. IMA Life’s investment in Western New York will help provide the critical equipment needed for pharmaceutical companies to manufacture life-saving drugs, while also creating the jobs needed to grow and support the healthcare sector,” said New York Governor Kathy Hochul during the groundbreaking ceremony (1).

Ernesto Renzi, president of IMA Life North America, said, 

We have deep respect for the life-saving medicines our customer’s process using IMA equipment, and we look forward to expanding our production capabilities and adding jobs right here in Western New York. The impressive competence of the workforce has allowed us to grow our customer base and expand the company.”

IMA Life North America is one of six IMA Life production sites. IMA Life produces equipment that meets maximum levels of sterility and is shipped worldwide. The Tonawanda facility manufacture large freeze dryers that rapidly convert vials of liquid medicines into a shelf-stable powdered form that is easy to transport. Products include blowers, washers, depyrogenating tunnels, liquid and powder fillers, freeze dryers, automatic loaders/unloaders, labelers, and isolation systems.

At INTERPHEX 2024 in New York City in April, IMA Life received the Best New Product/Service award for the company’s KryoAir air-based refrigeration system for freeze dryers. KryoAir is a single-state, oil-free system that requires minimal maintenance and can deliver consistent cooling output across different temperatures, according to the company (2).

The turbo-compressor-expander technology is augmented by the Cold Thermal Energy Storage (CTES) system, which harnesses the power of phase-transitioning compounds to maximize capacity per unit of volume. This enables the turbo-compressor-expander technology to support intensive and discontinuous energy applications.

“Pairing CTES with the turbo compressor expander, KryoAir transforms a well-established technology into a powerhouse of clean energy utilization. This dynamic synergy allows KryoAir to achieve extreme low temperatures with unprecedented efficiency, all while maintaining a compact and reliable design,” the company stated in a press release (2).

IMA Life. Groundbreaking Ceremony for IMA Life North America in Tonawanda, USA. Press Release. May 16, 2024.

IMA Life. IMA Life Wins INTERPHEX NY Awards for the Third Consecutive Year. Press Release. April 10, 2024.

The new 80,000-square-foot facility will increase production of the company’s freeze-drying equipment.

IMA Life North America Breaks Ground on New Facility in Tonawanda, NY

Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India, at Merck Life Sciences Pvt, Ltd.

K. Vasantakumar Pai, PhD , is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University

K. Sreedhara Ranganath Pai, PhD, is professor, epartment of Pharmacology, Manipal Academy of Higher Education

Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC, at Merck Life Sciences Pvt, Ltd.

Somasundaram Gopalakrishnan, is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd.

Tathagata Ray is Area Manager, Process Development at Millipore India Pvt. Ltd (India).

The COVID-19 pandemic has given the bio/pharma industry lessons on being prepared to manufacture parenteral formulations for human use in emergency situations. Vaccines, remdesivir injection and amphotericin injection, are such recent examples. The challenge then becomes having enough flexibility in the manufacturing lines to facilitate manufacture of large volumes of unit doses of injectables as may be required with shorter changeover times, while assuring compliance and patient safety from the product contact parts used in the manufacturing line. Single-use manufacturing solutions provide the flexibility in terms of batch sizes, fill volumes, and ease of manufacturing, especially in terms of manufacturing different products in the same line with minimum line changeover requirements. This article reviews and elaborates the initial risk assessment process for extractable and leachables arising from single-use product contact manufacturing parts as per 

) chapters <665> and <1665>, which go into effect May 1, 2026 (1,2). The determined risk can then be used to build the level of extractable profiling and process equipment-related leachables (PERLs) followed by assessing the patient safety for regulatory submissions. 

Application of the Risk Evaluation Matrix as per 

<665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

Manufacturing systems used for biopharmaceutical drug substances or drug products can be partially or completely constructed from plastic materials. During the manufacturing process, the drug product and its components could directly come in contact with the plastics and potentially interact with one or more of the manufacturing system’s product contact components. The substances that leach from a product contact manufacturing component could become incorporated into the process stream. If these leached substances persist in the process stream and continue through the process operations, they could accumulate in the drug substance or drug product as PERLs (1,2). When present in the drug product, these PERLs can potentially alter the critical quality attributes of the drug product, such as its stability, efficacy, and safety. 

Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products

, addresses these interactions by providing a risk-based means for chemically characterizing and qualifying plastic components used to manufacture biopharmaceutical drug substances and pharmaceutical and biopharmaceutical drug products. 

Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products

, communicates the key concepts behind and provides additional information and guidance regarding the applicability and the application of 

 <665>. The authors discuss a practical approach by which 

 <1665> can be applied in a step-by-step manner for the risk assessment, using a case study involving the manufacturing process for remdesivir injection and single-use technologies (Merck).

The testing of a product contact component is driven by the risk that the component may be unsuited for its intended use based on chemical or biological effects attributed to PERLs (1). As such risks increase, the degree of required testing also increases. The risk assessment process is accomplished by a risk evaluation matrix that establishes the appropriate contributors to the dimension of risk, provides a quantifying means for the risk in each dimension, quantifies the total risk for each dimension, and links the quantified risk to an appropriate characterization strategy.

 <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. 

 <1665>, Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. 

Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India. Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC. Tathagata Ray is consultant, Global Strategy Deployment; all at Merck Life Sciences Pvt, Ltd. K. Vasantakumar Pai, PhD, is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University. K. Sreedhara Ranganath Pai, PhD, is professor, Department of Pharmacology, Manipal Academy of Higher Education. Somasundaram Gopalakrishnan is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd.

*To whom all correspondence should be addressed.

When referring to this article, please cite it as Mavuleti, R. R.; Pai, K. V.; Pai, K. S. R.; et al. Application of the Risk Evaluation Matrix as per 

<665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing. 

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

Cresset, a UK-based company focused on solutions for computational drug discovery and development, announced on May 13, 2024, that it is opening a new headquarters in Bangalore, India. This news follows the establishment of Cresset’s new facility in Boston earlier in 2024. The facility in Bangalore, one of India’s leading areas for biotechnology and pharmaceutical research, is intended to expand Cresset’s existing Asia-Pacific presence, increasing its reach across the region to include markets such as South Korea, Japan, China, and Australasia.

Cresset intends to take advantage of the nearby chemistry talent available in Bangalore. New staff appointments in India will encompass a range of areas, including sales, support, and development.

“Launching our new site in India marks a major milestone in our international growth and expansion as a company,” said Mark Mackey, PhD, co-founder, chief scientific officer, Cresset, in a press release (1). “The talent pool and centers of excellence available in the region will enable us to expand our existing service offering to clients and develop strong relationships through face-to-face contact on the ground.”

“We already have a satellite office space in Bangalore, where a high proportion of our Indian staff are currently based,” Mackey continued. “The new office will allow us to grow our overall business and gain access to grant funding in the Indian market.”

Bangalore is a popular area for expansion. On Oct. 30, 2023, Aragen, a contract research development and manufacturing organization, announced its new biologics manufacturing facility in the city, as part of a $30 million investment (2). The planned 160,000-square-meter facility is set to include process development labs and multiple good manufacturing practice (GMP) suites, as well as supporting functions such as quality control labs. It is designed to facilitate solutions across the biomanufacturing lifecycle and will be equipped to develop and manufacture monoclonal antibodies, therapeutic proteins, and fusion proteins.

Aragen has since operationalized the first phase of the facility, which it announced in a press release on Mar. 27, 2024 (3). It also executed its first small-scale manufacturing project for a US-based organization, a novel anticancer monoclonal antibody. The facility can process batch sizes up to 50 liters and includes process development and analytical labs.

“We are happy to announce the commissioning of the first phase of our biologics manufacturing facility at Bangalore, India as per schedule and the successful completion of the first project at this facility,” said Manni Kantipudi, CEO of Aragen Life Sciences and director of Aragen Biologics, in the press release (3). “This brings us one step closer to offering full-scale Gene-to GMP solutions to our customers. Once the facility’s expansion is fully operational by the end of this calendar year, we will be able to do internal tech transfer from our R&D labs in California to the manufacturing site in India, thereby enabling end-to-end integrated service offering to customers.”

Cresset Group. Cresset Targets Global Growth with New India HQ. Press Release, May 13, 2024.

Establish $30 Million Biomanufacturing Facility in India

Aragen Operationalizes First Phase of its Biologics Manufacturing Facility in India

The drug discovery company intends for this new site to increase its reach in the region, supporting growing demands from its Asia-Pacific consumers.

Cresset to Open New Headquarters in Bangalore, India

At its April 2024 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight medicines for approval: Altuvoct, Fruzaqla, Jeraygo, Obgemsa, Truqap, Tofidence, Wezenla, and Eribulin Baxter (1).

Altuvoct (efanescotocog alfa) was recommended for a marketing authorization for the treatment and prophylaxis of bleeding in patients with hemophilia A, which is a rare genetic bleeding disorder cause by a lack of factor VIII. Fruzaqla (fruquintinib) received a positive opinion for the treatment of patients with previously treated metastatic colorectal cancer. Jeraygo (aprocitentan) also received a positive opinion, for the treatment of resistant hypertension. CHMP gave a positive opinion to Obgemsa (vibegron) for the treatment of adult patients with overactive bladder syndrome. Truqap (capivasertib) received a positive opinion for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations.

Tofidence (tocilizumab) and Wezenla (ustekinumab), both biosimilar medicines, received positive opinions from the committee. Tofidence received a positive opinion for the treatment of COVID-19, rheumatoid arthritis, systemic juvenile idiopathic arthritis, and pediatric plaque psoriasis. Wenzela received its positive opinion for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Erubulin Baxter (eribulin), a generic medicine intended to treat breast cancer and liposarcoma, a rare disease which develops in fatty tissue, also received a positive opinion from the CHMP.

In addition to the positive opinions, two applications for marketing authorization were withdrawn. The first was for GeGant, a radionuclide generator that doctors can use to label diagnostic medicines. A question-and-answer document on the withdrawal of GeGrant is available 

. The second was Upstelda, a biosimilar treatment for plaque psoriasis, psoriatic arthritis, and Crohn’s disease, which is a duplicate of Wezenla. The committee also recommended extensions of indication for six medicines already authorized in the European Union: Alescensa, Opdivo, Rozlytrek, Rybrevant, Sirturo, and Triumeq. The committee recommended new contraindications on the co-administration of Reyataz (Atazanavir) with ivosidenib and encorafenib, and with phenobarbital, phenytoin, and carbamazepine.

In regulatory updates, EMA is currently reviewing the impact of the appellate judgement of the Court of Justice (March 14, 2024) on the evaluation of Hopveus, the subject of the court case, as well as other regulatory procedures. Because of this, CHMP has created a new ad-hoc expert group (AHEG) for Syfovre and will reset the evaluation procedure for this treatment from the point of reset to day 180 of the initial assessment. The judgement reviewed questions related to the organization of EMA’s Scientific Advisory Groups and AHEGs, which are both groups that are called upon by EMA to respond to questions from the EMA’s committees during a medicine evaluation. The agency wrote that it is “considering the impact of the appellate judgment on the evaluation of other regulatory procedures,” and “will further communicate as appropriate” (1).

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

Featured Content

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