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Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Pharmaceutical Technology® sits down with Henny Zijlstra from Adragos Pharma to chat about the trends affecting the outsourcing market, various strategies being employed by service providers, and the value of end-to-end services.

DCAT Week 2025: Gaining End-to-End Clarity

Looking at the outsourcing market more from the customer side, Henny Zijlstra, chief commercial officer for Adragos Pharma, specifies that a key trend is onshoring. European companies are shying away from Asia and India more so and are preferentially looking for goods and services based with Europe instead, she explains. In addition to onshoring, the geopolitical situation is high on the agenda, leading to more companies looking at outsourcing manufacturing in Europe versus the United States, she adds.

“I don't believe that [customer] demands have [necessarily] increased or changed,” Zijlstra continues. “I think it's more the service levels that [customers are] looking for which are different.” For service-providers, being customer focused is key, she remarks, making sure the customer is prioritized and have full transparency during their development project.

“In general, we've seen that it's not only Big Pharma looking for outsourcing [partners anymore],” Zijlstra says. “The biotechs [also] need these service levels, and they need the help to make sure that they actually get to the next phase of their development, to either secure their funding or to actually get to the patients faster. So, from that perspective, an end-to-end service, gives you the clarity.”

Henny Zijlstra, Chief Commercial Officer of Adragos Pharma

Henny Zijlstra, Chief Commercial Officer (CCO) of Adragos Pharma, is a strategic and customer-focused leader with a Master’s in Business and a robust background in International Business. With nearly 18 years of experience in the pharmaceutical industry, she began her career in business development, sales, and product management before rising to management and more commercially focused roles.
Her career includes significant roles in sales, product management, and global business development at renowned companies such as DSM, Lonza, and Hetero Europe. Passionate about challenging conventions, Henny consistently pushes boundaries to develop forward-thinking strategies that drive growth and transformation.
As CCO, Henny leads with a compelling vision, instilling a customer-centric mindset across the organization. Her commitment to excellence and industry progress fuels Adragos Pharma’s mission to deliver impactful innovations.

Videos

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Anil Kane DCAT Week Interview

The bio/pharmaceutical industry is feeling the pressures of demand across numerous drug modalities and dosage forms in 2025; identifying where that demand is greatest and then figuring out how to serve that population is of utmost importance, according to Anil Kane, PhD, global head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific. 

® spoke with Kane on site at the Drug, Chemical & Associated Technologies Association (DCAT) Week event on March 17, 2025, where Kane addressed, among other trends, the major topic of glucagon-like peptide-1 (GLP-1) drugs, as well as new ways of improving the clinical trials process.

“At Thermo Fisher—in the Pharma Services group specifically—we continue to see and monitor the market demand in terms of, what are those therapeutic areas that our customers would like to address, what are the types of molecules, what are the capacities and the demands of our customers?” Kane says in the interview. “And then we continue to monitor these and make strategic discussions with our partners and either leverage our existing capacity or are in discussions: How do we meet those demands, to meet the future requirements, to see the molecules reach the patient in the coming years?”

Kane also touched upon Thermo Fisher Scientific’s Accelerator Drug Development services, 

 This offering is described by the company as its 360° contract development and manufacturing organization and contract research organization drug development solutions.

DCAT Week is happening March 17–20, 2025 in New York City.

Click the video above to watch the full interview.

Anil Kane, PhD, Global Head of Technical & Scientific Affairs, Pharma Services, Thermo Fisher Scientific

Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process, spanning early-stage development to scale-up and commercial manufacturing and includes technical transfers between global sites and drug life cycle management. Kane received his Bachelors, Masters, and PhD degrees from the Bombay College of Pharmacy, University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive Master of Business Administration degree from Richard Ivey School of Business, University of Western Ontario, Canada. Kane is a member of various international pharmaceutical professional organizations and is often asked to speak about scientific topics on formulation, technology, and other technical aspects at major industry events. He has also published many articles in international journals and delivered many talks at meetings and conferences across the globe.

PharmTech Group sat down with Anil Kane of Thermo Fisher Scientific live on site at DCAT Week 2025, to talk about technologies and digital solutions companies are using to meet demand across the bio/pharma industry.

DCAT Week 2025: Keeping Up with Drug Demand

In an interview with Pharmaceutical Technology®, Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.

Industry Outlook 2025: A Busy Time Ahead

According to Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, the mega trends from 2024, such as the digital transformation, supply chain globalization, and regulatory reforms, will continue to keep the industry busy in 2025. Industry hasn’t quite matured enough yet, he stresses, and is still getting to grips with how each of the mega trends will have an impact in the future.

“Breaking it down into operations, AI [artificial intelligence]-driven drug discovery or development will be tremendously accelerated and [enable the] identification of potential new drug candidates by analyzing vast amount of data sets, predicting drug efficacy, and optimizing clinical trial designs,” Bergsteiner says. “This approach [will] reduce time and costs associated with traditional drug development.”

There have already been successes with AI-approaches seen in the field of personalized drugs, Bergsteiner adds. “The human metabolism is so different between patients,” he explains, “but AI enables us to develop treatments tailored to individual genetic profiles, improving therapeutic efficiency, efficacy, [and] reducing adverse reactions.”

Tore Bergsteiner, Managing Partner at MAIN5

Tore Bergsteiner is Managing Partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. Tore has approximately 30 years of experience in industry and has been a pioneering influence in the field of electronic regulatory submissions and within the management and publishing servicing industry. He previously worked for EXTEDO GmbH, a leading international product vendor of electronic approval systems for publicly owned and private pharmaceutical industry, and IABG GmbH, a major German technology and operating company. Tore graduated in Computer Sciences in 1996 and studied at the University of Bremen, Germany, the University of Texas, Austin, USA, and the Julius Maximilian University of Würzburg, Germany.

DCAT Week Interview with Lee Karras

 announced for the Halo Pharma facility in Whippany, NJ, on March 10, 2025, Noramco Group Chief Executive Lee Karras spoke with 

® on the first day of the 2025 Drug, Chemical & Associated Technologies Association (DCAT) Week on March 17.

The purpose of the investment at the New Jersey site, as Karras detailed in the interview, is to establish sterile injectable manufacturing capabilities, namely ready-to-use syringe, cartridge, and vial filling, to address critical capacity shortages in the injectable supply chain in the United States.

“We have reconfigured some of the plant space to accommodate a commercial, aseptic filling line for vial, syringes, and cartridges,” Karras says in the interview. “That line has been delivered, and we're going through the construction and installation process that will take us into early next year to be ready to produce products. This line represents an investment by The Noramco Group to alleviate products that are on drug shortage [lists] but also work on innovator products as well. So, we're not only going to do clinical manufacturing for NCE [new chemical entity] products, but we're also going to do biologics and small molecules. We're going to do commercial manufacturing domestically, obviously out of New Jersey, to supply the [United States] market, but also have our eyes set on more global regulatory approvals to ship outside of the US.”

Lee Karras, Noramco Group Chief Executive

Mr. Karras joined Noramco in April 2020, as Group Chief Executive. He is responsible for the Noramco Group of Companies, including Noramco, Purisys, Extractas Bioscience, and Halo Pharmaceuticals. Mr. Karras previously served as a director at SK Capital and CEO of Halo Pharmaceuticals Inc. Prior to Halo, Lee was President of IBA Molecular North America, a radiopharmaceutical company that provided PET imaging agents for diagnostic imaging. Prior to IBA, Mr. Karras was President and CEO of AAIPharma Services Company, a drug product CDMO, where he led the company’s transition from bankruptcy to a standalone CDMO/Pharma Services business.Prior to AAI, Lee held various positions at Baxter Healthcare and Cook Medical (Cook and Baxter Pharmaceutical Solutions). He served as General Manager and helped build the pharmaceutical services start up into one of the largest sterile injectable pharma services businesses in the world. Lee holds a bachelor’s degree in chemistry from Indiana University Bloomington and a Master of Science in Environmental Science from Indiana University Bloomington School of Public and Environmental Affairs.

PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.

DCAT Week 2025: Expanding Sterile Injectables Capacity

DCAT Week 2025: Impact of Geopolitical Climate on Biopharma

® spoke with Joseph Principe, chief commercial officer at Abzena about how current events around the world are impacting the bio/pharmaceutical industry, especially the supply chain and drug shortages.

According to Principe, the current geopolitical climate is creating uncertainty in the bio/pharmaceutical industry. “The industry doesn't really like uncertainty. I think the circumstances around [the] BIOSECURE [Act] or potential tariffs, all sort of create this uncertainty,” he says. “I think that is creating some tailwinds for Western suppliers, particularly those in the [United States]. But again, lots of uncertainty. I think we see that depending on the type of customer that we're talking to, some of the early developers have a little bit less concern about the geopolitical situation, and people who have supply chains embedded in the regions and in many cases, they're looking for alternatives to avoid some of the uncertainty.”

Abzena will be attending DCAT Week 2025, which is happening in New York City from March 17–20, 2025.

Click on the video above to watch the full interview.

PharmTech sat down with Joseph Principe, chief commercial officer at Abzena ahead of DCAT Week 2025 to get his perspective on how the geopolitical climate is impacting the industry.

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

DCAT Week 2025: Quality and Compliance for Animal-derived Products

“There are two main differences in terms of quality and compliance that you have to take into account when you're handling animal-derived products,” explains Roger Viney, chief commercial officer of ICE Pharma. “The first is to have steps in your process that ensure biological inactivation, whether it's of course, removal of bacteria, denaturing of DNA, and particularly viral inactivation.”

Secondly, Viney adds that traceability is important: Knowing the exact origin of the animal-derived material means that should there be any issues in a particular country or with a particular disease, it is easy to identify and segregate the material that will be affected, he remarks.

Looking at regulatory requirements, Viney points out that harmonization is critical and allows for increased security of supply. Furthermore, offering fully integrated services is an added benefit for customers as it provides them with the confidence in traceability of the products, he specifies.

 spoke with Viney about the utility of bile acids as excipients to help improve solubility and bioavailability. The interview can be viewed by following the link below:

https://www.pharmtech.com/view/improving-solubility-and-bioavailability-with-bile-acids

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

Feliza Mirasol is the science editor for 

A discussion on aseptic sterile processing in pharmaceutical manufacturing with Simtra BioPharma Solutions' Lidia Serina.

A Discussion on Aseptic Processing for Sterile Injectable Manufacturing (DCAT Week 2025)

In an interview with the PharmTech Group ahead of DCAT Week 2025, Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the key challenges in aseptic processing for sterile injectables. Among the primary hurdles are the preservation of aseptic conditions throughout complex, multi-hour manufacturing processes while ensuring product stability, especially for sensitive molecules such as antibody-drug conjugates (ADCs); upholding cold chain logistics to maintain temperature-sensitive products during processing and shipping across global supply chains; and adherence to stringent safety standards for highly potent and cytotoxic molecules to protect both the workforce and the final drug product.

To address these challenges, Simtra is leveraging advanced automation, digitalization, and lean manufacturing practices. This includes enhanced digital monitoring, robust technology transfer protocols, and facility designs tailored to mitigate risks. The company is also expanding its capabilities in highly potent and cytotoxic manufacturing, as well as dedicated suites for ADCs.

"In parallel to the digitalization environment, we are also improving the way we do technology transfer … from when we receive a molecule and a process from a client [to when] we transfer this knowledge onto our aseptic filling lines … we need to make sure that we understand the critical process parameters [and] the quality attributes of the molecule, so we are actually able to keep the stability of this molecule along the manufacturing process [even to] the patient, right when we ship the product to the patient," Serina says.

DCAT Week is being held March 17–20, 2025 in New York City.

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions

Lidia Serina, PhD, is head of Development Services at Simtra BioPharma Solutions, leading a strategic area essential to the company’s mission. She partners with clients to develop high-quality injectable products and efficient manufacturing processes. With extensive experience in supply chain, vaccine R&D, quality and regulatory compliance, and both commercial and clinical manufacturing, Serina’s technical expertise spans a wide range of molecule types. Her leadership drives innovative solutions to the complex challenges of product development and manufacturing.

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the challenges with maintaining aseptic integrity in sterile injectable pharmaceutical manufacturing.

DCAT Week 2025: A Discussion on Aseptic Processing for Sterile Injectable Manufacturing

Pharmaceutical Technology® sat down with Tore Bergsteiner from MAIN5 to discuss the most pertinent and impactful bio/pharma industry trends from 2024.

Industry Outlook 2025: Looking at the Mega Trends

The past year, 2024, was a very active one, remarks Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. “There have been a lot of changes and trends, especially in the political legislative perspective, but also related to new technical trends, influences which are gaining more momentum and maturity,” he says.

Firstly, a key trend for industry, Bergsteiner points out, is artificial intelligence (AI) and the digital transformation that is being seen. “[AI] will become a more and more relevant technique impacting our daily businesses, our overall competitiveness in the industry,” he notes. “And we have to consider that accelerated adoption and processes driven by AI/machine learning or large language models are already reshaping a variety of key processes in pharma.”

The second trend of note for Bergsteiner is the globalization of the supply chain and the monitoring of critical medicines and relevant shortages. “That means diversifying efforts to continue reducing dependency on single regions such as India or China for API, and manufacturing needs to be decreased,” he says.

Continued regulatory reforms and harmonization make up the third key trend from 2024 for industry, emphasizes Bergsteiner. “There are streamlined pathway in the US [United States] and in the EU [European Union], fostering innovation, especially in the area of rare diseases and oncology,” he remarks. “Those [pathways] are pushing companies more and more to continue digitizing their end-to-end processes to remain competitive and regulatory compliant.”

Pharmaceutical Technology® chats with Simon Wright from Almac Pharma Services about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand. 

DCAT Week 2025: Recognizing the Value of CDMOs

Therapeutic modalities are diversifying across the bio/pharma industry, explains Simon Wright, vice president of Business Development for Almac Pharma Services. “Whilst there remains a strong demand for traditional small molecules, we see a higher percentage growth in areas such as biologics, vaccines, cell and gene therapies, and I guess, most recently, peptides,” he says. “And these drugs are administered through various formats, ranging from oral to injectables, but with an increasing trend towards drug–device combinations.”

In addition, regulatory and financial incentives are giving rise to increased attention on novel drugs that treat rare and difficult-to-treat diseases that have smaller patient populations, Wright adds. With these trends in mind, contract development and manufacturing organizations (CDMOs) need to offer flexibility as a strategic partner to innovators, he specifies.

“We're really seeing a desire for more of a strategic partnership versus maybe more of that traditional transaction relationship [from sponsor companies],” Wright says. “I truly believe that the evolution of sponsor CDMO relationships reflects how pharmaceutical companies recognize the value of CDMOs within their overall network and ecosystem. I think that the most strategic relationships today are characterized by strategic partnership approach where companies leverage specialist expertise and trust the CDMOs to assume greater responsibility and deliver substantial value.”

Simon Wright, vice president of Business Development for Almac Pharma Services

Simon Wright is Vice President of Business Development for Almac Pharma Services, part of Almac Group. In his role, Simon leads the business development team across both Europe and North America, and he supports the company’s marketing efforts for the business unit. Simon has approximately 30 years’ experience in the CDMO space.

India-based Shilpa Biologicals, a fully owned subsidiary of Shilpa Medicare Limited, announced on March 17, 2025 that it has entered into a strategic partnership with Switzerland-based mAbTree Biologics. The companies will co-develop and commercialize mAbTree’s novel biologic asset—a checkpoint inhibitor for immuno-oncological applications.

Under the agreement, Shilpa Biologicals will support development—including clinical studies—and long-term commercial supply with good manufacturing practice (GMP) manufacturing. Meanwhile, Shilpa Group will provide mAbTree access to India and several global markets through its partner network (1).

The partners aim to develop a fully human monoclonal antibody (mAb) against a novel immune checkpoint protein. This protein enables T-cell activation and the generation of strong immune responses against tumors, similar to the more well-established blocking action of programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1).While blocking PD-1/PD-L1 has demonstrated significant clinical successes, recent studies suggest that Shilpa Biologicals’ and mAbTree’s novel target carries a highly attractive therapeutic potential in various immuno-oncological states as both a monotherapy and combinatorial therapy. Their approach has the potential to convert cold tumors (those with poor immune cell infiltration) to hot (having good immune infiltration). Their approach can also suppress tumor metastasis and make refractory tumors susceptible to chemotherapy. This target is applicable in various cancers, including lung cancer, head and neck squamous cell carcinoma, and hematologic malignancies, according to a company press release (1).

“We are delighted to enter this strategic collaboration with mAbTree Biologics as we share a common vision to bring innovative solutions to address unmet medical needs around the globe, especially in the field of oncology where Shilpa has had a long history of providing affordable innovative solutions,” said Madhav Bhutada, director, Shilpa Biologicals, in the press release (1).

Shilpa Biologics’ large R&D teams will provide full-service capabilities, from cell line development to GMP drug product manufacturing. Manufacturing activities and the provision of clinical supply will be conducted at the company’s biomanufacturing facility at Dharwad, Karnataka, in India.

“mAbTree is excited to continue our strategic partnership with Shilpa Biologicals and our aim is to enable greater access to medicines for more patients across the world, especially focusing on India and ROW [rest of world] markets where access has been limited,” said Raj Andhuvan, CEO, mAbTree in the release. “But what really impresses us about Shilpa is their commitment and scientific expertise. We look forward to rapidly advancing therapeutic options in the NBE [new biological entity] space and to addressing emerging health challenges.”

mAbTree’s pipeline (including this asset under the partnership with Shilpa Biologicals) includes two oncology assets that have completed preclinical studies and two assets currently in the R&D phase, one multiple sclerosis and the other in psoriasis. The rest of the company’s pipeline includes two undisclosed candidates in the investigational new drug application-enabling phase, one in the 

 proof-of-concept phase, and two in the lead optimization phase (2).

Shilpa Biologicals’ pipeline primarily includes biosimilars in various stages of development. It has an adalimumab biosimilar that has complete Phase III trials, an aflibercept biosimilar entering Phase III trials, and a FC fusion protein biosimilar and another mAb biosimilar in preclinical studies. The company also has a new biological entity, recombinant human albumin, that has started Phase III trials (3).

1. Shilpa Biologicals. Shilpa Biologicals Pvt Ltd Signs Strategic Development Partnership with mAbTree Biologics AG for a Novel Immuno-Oncology Asset. Press Release. March 17, 2025.
2. mAbTree Biologics. Pipeline. 

 (accessed March 17, 2025).
3. Shilpa Biologicals. Product Portfolio. 

Articles

The partnership aims to develop and commercialize a novel checkpoint inhibitor for immuno-oncology applications.

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