Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Feliza Mirasol is the science editor for 

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.”

Videos

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.

Articles

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

Pharmaceutical Technology’s Trends in Manufacturing

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.

Pharmaceutical Technology’s Trends in Manufacturing May 2024 eBook

 <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

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

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.

EMA Recommends Eight Medicines for Approval in April

Video interview with Ray Guidotti, Chief Operating Officer, Simtra BioPharma Solutions

Talking Strategic Development with Simtra at DCAT

Simtra BioPharma Solutions is a premier contract development and manufacturing organization (CDMO) with more than 65 years of sterile injectable (SI) experience and a dedicated focus on providing a range of services from clinical development to commercial fill/finish. Learn more about:

Simtra’s new building in Halle that features a high-speed syringe line and vial line equipped with four lyophilizers and is expected to be GMP ready in 2024.

The new clinical line in Bloomington that will be ready to take on projects in the summer of 2025.

Construction of the new state-of-the-art building in Bloomington that will begin in the summer of 2024.

Ray Guidotti, Chief Operating Officer at Simtra BioPharma Solutions, talks about the company's strategic development and how it supports customers with a focus on excellence. 

Video interview with Adam Covitt, President, Federal Equipment Company

Federal Equipment Company: Supporting CDMO Operations Through Training, Parts, and Equipment

At a recent Drug, Chemical & Associated Technologies (DCAT) conference, 

spoke with Adam Covitt, President of Federal Equipment Company, to hear the latest in the CDMO landscape. Learn more about: 

An introduction/re-introduction to Federal Equipment Company.

Challenges and opportunities in the 2024 CDMO landscape.

How Federal Equipment Company can assist CMDO success with its Techceuticals and PharmParts business brands.

Adam Covitt, President of Federal Equipment Company, discusses how the company enables CDMO successes with its Techceuticals and PharmParts business brands. 

Video interview with Peter DeYoung, CEO, Piramal Pharma Solutions

At DCAT With Piramal Pharma Solutions

spoke with Peter DeYoung, CEO, Piramal Pharma Solutions, to learn more about the company's offerings. Watch to learn more about: 

Piramal's key service offerings and integrated solutions in the areas of oncology and ADCs.

The current operating environment for CDMOs and industry trends.

Piramal's strategy to expand its territorial footprint in the US beyond its existing facilities. 

Peter DeYoung, CEO, Piramal Pharma Solutions, talks about recent company achievements and key offerings, as well as current industry trends. 

American Society of Gene and Cell Therapy’s (ASGCT’s) 27th Annual Meeting

, Alex Meola, associate director of AAV Downstream Process Development at Oxford Biomedica, showed that hydrophobic interaction chromatography (HIC) is a useful tool for separating non-deamidated capsids from deamidated capsids, according to studies conducted by his team. The ASGCT annual meeting is occurring on May 7–11, 2024 in Baltimore, Md.

Meola emphasized how the focus on post-translational modification of capsid proteins of the adeno-associated virus (AAV) is growing in the process and analytical development space for gene therapies. The industry has been particularly focusing on how the deamidation of capsid protein from viral protein 1 (VP1)-specific residues, including the N57 domain, is linked to a loss of 

“Temperature, pH, and storage time have been identified as key factors causing this phenomenon,” Meola. “In our quest at Oxford Biomedica—to try and resolve this—we have a static binding capacity residence screening protocol that we run where we look at a variety of different residents. In this case, we decided to look at salt-tolerant residents,” he stated.

Besides process control to prevent deamidation, Meola’s team hypothesized (2) that extrusion of VP1 and deamidation of N57 are related phenomenon and result in generating empty, partial, and full capsids, which significantly influences the ability of the anion exchange chromatography (AEX) process. AEX’s ability to remove empty capsids and deliver functional AAV is thus compromised.

Meola noted that charge-driven separation techniques have not provided the resolution required to differentiate between deamidated and non-deamidated capsid species. Because of this, his team highlighted novel approaches that can be applied to the AEX process to address the complex challenge of removing both empty capsids and deamidated intact capsids. “Controlling strategies in the upstream and downstream processes should be studied and defined at the early stage of process development to limit onset of deamidation in order to minimize product related impurities and loss of vector functionality,” Meola stated.

One of the team’s first approaches was to use HIC to separate distinct peaks with near baseline resolution. After separation, each peak was isolated and individually reprocessed with AEX. “Surprisingly, we discovered that HIC resolved two different species of AAV capsids with near baseline resolution. Each species was reprocessed on AEX, and all product quality attributes were assessed for the intermediate peaks that were generated. We found that the capsids that were more hydrophobic were also more negatively charged,” he explained.

Furthermore, data from liquid chromatography–mass spectrometry analysis demonstrated that the more hydrophobic and more negatively charged capsids exhibited significant levels of VP1-specific N57 deamidation, which has been linked to a loss in gene expression. It was demonstrated, therefore, that the extrusion of VP1 exposes the hydrophobic phospholipase A2 domain on the VP1 unique region, a phenomenon that would make VP1 N57 residue exposed to solvent and thus susceptible to deamidation.

The team was thus able to demonstrate that HIC can be a useful method to separate non-deamidated capsids from deamidated capsids. Meola also stated that the team is working on a novel, patent-pending method to remove deamidated species while simultaneously enriching full capsids on the AEX process.

1. Giles, A.; Lock, M.; Chen, S. J.; et al. Significant Differences in Capsid Properties and Potency Between Adeno-Associated Virus Vectors Produced in Sf9 and HEK293 Cells. 

 (19–20),1003–1021. DOI: 10.1089/hum.2022.116
2. Meola, A.; Aguiar, A.; Chong, C.; et al. Not Created Equal: Impact of Deamidation on Capsid Heterogeneity and Anion Exchange Chromatography (AEX) Performance. Paper Abstract. annualmeeting.asgct.org (accessed May 8, 2024).

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach