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Behind the Headlines Episode 26

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Ask the Expert

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Drug Digest September 2025

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Top Trends Reshaping Pharma R&D

Feliza Mirasol is the science editor for 

The winners of the 2025 Pharmapack Awards were announced on Jan. 22, 2025, according to Pharmapack Europe. The awards, which have been newly reformatted, recognize excellence in six key categories. In addition, this year’s awards used a new approach in which both commercialized products and groundbreaking innovations expected to shape pharma packaging's future were celebrated. For the first time, these awards were open to all participants in an effort to foster greater inclusivity and innovation, according to a press release (1).

The winners included many significant advancements, such as an autoinjector that eliminates the need for manual needle attachment, a fully recyclable and heat-sealable ultra-high barrier paper, and a multi-layered vial that is designed for storing gene therapy product. Other innovations included a prefilled syringe pack that reduces packaging waste by 62% and a non-electronic, eco-friendly label that can monitor both time and temperature. This year also saw the first “Women of the Year” commendations presented.

In the Delivery and Device Innovation category, the winner was Switzerland-based SHL Medical’s Elexy, a reusable electromechanical autoinjector, which was developed from years of innovative research. This autoinjector is drug-agnostic and has the widest range of primary container flexibility among autoinjectors, which means the device can caters to both prefilled syringe- and cartridge-based primary containers. The cartridge-based version of the autoinjector features SHL’s proprietary Needle Isolation Technology (NIT), which comprises a pre-installed needle housed within the cap of the autoinjector. This design eliminates the need for manual attachment of the needle and offers patients a more convenient device.

The winner of the Eco-Design category was Finland-based Huhtamaki’s fully recyclable, heat sealable, ultra-high barrier Omnilock Ultra Paper. This ultra paper is specially engineered to replace non-recyclable multi-layer laminates, including laminates made of paper, plastic, and aluminum. The product represents a significant innovation in sustainable packaging as it offers ultra-high barrier properties that were previously only found in non-recyclable multi-layer combinations of aluminum foil and plastic. Omnilock has a paper content ranging from 87–93% and is derived from FSC-certified fibers. The product maintains superior barrier performance while at the same time being environmentally friendly.

In the Packaging Innovation category, Japan-based Mitsubishi Gas Chemical (MGC) won for its new vial, the OXYCAPT Multilayer Plastic Vial, which is designed to store gene therapy products using dry ice and liquid nitrogen. Standard cyclic olefin polymer (COP) vials have a poor gas-barrier (2), making COP vials inadequate for drugs that are sensitive to oxygen (O

), according to the Pharmapack press release (1). The OXYCAPT consists of three layers: the drug contact layer, the outer layer (both made of COP), and the O

barrier layer, which is made an MGC novel polyester. OXYCAPT therefore provides an excellent O

, and ultraviolet (UV) barrier that is 20 times better than standard COP monolayer vials.

The Patient-Centric Design category winner was Belgium-based UCB Pharma’s redesigned BIMZELX 160mg autoinjector packaging, which consists of innovative features and takes a patient-focused approach. The redesigned packaging incorporates 15 new design elements and enhances the patient’s unboxing experience by prioritizing ease of use, sustainability, and functionality. Key design highlights include a “book style” carton construction that displays instructions better, an intuitive reclosing mechanism, a tamper-evident design, and a plastic tray consisting of 50% recycled polyethylene terephthalate material.

The winner in the Start-Up Innovation category was Italy-based Active Label for its non-electronic, environmentally friendly labels designed to monitor both time and temperature. These smart labels are activated with near-monochromatic UV light. They use engineered materials developed through research in collaboration with universities and research centers. Information from these labels is read using a compact reader that utilizes optically stimulated luminescence (OSL) and a proprietary algorithm that converts signals into time and temperature data. These data are stored in the cloud, which makes the data accessible remotely.

Pharmapack’s first inaugural Woman of the Year Award went to Asmita Khanolkar, senior director, Combination Products, Drug Delivery, Sterile Manufacturing, Device/Pharma Strategy and Commercialization, at US-based SMC Ltd. Khanolkar has more than two decades of experience, where she has managed and led various products from concept to commercial launch. Her product portfolio includes single-use, wearable and implantable devices, drug-device, device–biologic combination products for drug delivery, biotech, and biotherapeutics. The application of these products includes various indications such as diabetes, pain management, cell therapy, tissue regeneration, orthopedic, vascular, women’s health, oncology, surgical products, and more. She has made a significant contribution to advancing healthcare, having launched multiple medical devices and commissioning manufacturing lines for novel devices, including for first-in-human, single-use, on-body, and implantable cell therapy delivery devices.

“This year, we’ve seen a record number of award categories, yet the quality and innovation of entries continue to reach new heights. Notably, many submissions demonstrate a strong commitment to advancing sustainability through reduced raw material usage, improved recyclability, and lower carbon footprints, all while enhancing patient and user experiences,” said Tara Dougal, brand and content director—Pharma, at Informa, in the press release. “These efforts reflect the industry's determination to address critical challenges and shape the future of healthcare. We applaud the entire pharma packaging and drug delivery sector for its relentless drive toward innovation and transformative care standards.”

1. Pharmapack Europe. Pharmapack Award Winners 2025 Redefining Pharmaceutical Packaging and Drug Delivery. Press Release. Jan. 22, 2025.
2. Sarmadi, M.; Holmes, S.; Agha, R.; et al. A Comparative Study of Freeze-Drying Heat Transfer in Polymeric Vials and Glass Vials. 

Articles

Winners in this year's Pharmapack Awards include both commercial products and innovations that are shaping the future of pharmaceutical packaging. 

2025 Pharmapack Winners Showcase Innovations in Pharma Packaging and Drug Delivery

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Provepharm announced on Jan. 24, 2025 that it has voluntarily recalled one lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) because a customer found a visible black particulate matter in a single-sealed vial. The recalled product is packaged in 10 mL, single-dose vials with national drug code 81284-213-01, lot number 24020027, and an expiration date of December 2025. It was distributed nationwide in the United States.

Phenylephrine hydrochloride Injection is used to treat hypotension resulting from vasodilation in the setting of anesthesia. Injecting product that contains particulates may cause local irritation and swelling.

“If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death,” the company stated in the press release (1).

The company advised wholesalers, distributors, compounders, and hospitals to immediately stop using the product and return it to Provepharm’s recall provider, Sedgwick. While the company states it has not yet received any reports of adverse events associated with the recall, these events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

Packaging problems, such as particulates and defective vials, are a common cause of product recalls. These recalls can be hazardous to the health of patients but can also be expensive for companies to resolve and prevent. In September 2024, Gilead recalled one lot of Veklury (remdesivir) for Injection 100 mg/vial after a customer complaint of a glass particle found in a vial. An investigation performed by the company confirmed the presence of the glass particulate. While at the time of the recall the company had not received reports of any adverse events associated with the recall, if administered, the glass particulate could travel to organs and blood vessels, causing stroke or death.

, Dirk Margosch, vice president visual inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, discussed steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (3). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences, according to Margosch.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

FDA. Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter. Press Release. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp

FDA. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle. Press Release. 

Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. 

https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Provepharm Recalls Phenylephrine Hydrochloride Injection

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Behind the Headlines: Sana's Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 10, we’re joined by Brian Feth, CEO and Founder, Xcell Biosciences; Jonathan Grinstein, PhD, North American Editor, Inside Precision Medicine; Beth Willers, Principal and Founder, White Matter Communications; and Laks Pernenkil, Principal, US Life Sciences Product, Supply and Manufacturing Operations Practice Leader, Deloitte Consulting, who discuss recent headlines from the pharmaceutical industry, including major announcements from the JP Morgan Healthcare Conference as well as changes arising from the change of administration in US government.

The group discussed Sana Biotechnology’s early trial results showing that allogeneic treatment without immunosuppression might be possible in type 1 diabetes. “The clinical data are highly promising for patients and provide the first evidence in humans for overcoming allogeneic and autoimmune rejection with pancreatic islet cell transplantation in type 1 diabetes with no immunosuppression,” said Per-Ola Carlsson, MD, principal investigator and senior physician and professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. (1)

Also discussed was the interconnected topic of proteomics, which appear to be having a moment thanks to the UK Biobank choosing the Olink platform for a major set of initiatives going forward. (2)

In addition, the participants weighed in on the latest round of Medicare price negotiations, with the medications listed encompassing a large percentage of overall drug expenditure, including Ozempic, Rybelsus, Wegovy, Trelegy, Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Austedo XR, Breo, Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, Janumet XR, and Otezla. (3)

Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression. , Press release. Sana Biotechnologies. January 7, 2025. 

https://www.globenewswire.com/news-release/2025/01/07/3005841/0/en/Sana-Biotechnology-Announces-Positive-Clinical-Results-from-Type-1-Diabetes-Study-of-Islet-Cell-Transplantation-Without-Immunosuppression.html

Thermo Fisher Scientific’s Olink Platform Selected for World’s Largest Human Proteome Study. Press release. Thermofisher Scientific. January 9, 2025. 

https://ir.thermofisher.com/investors/news-events/news/news-details/2025/Thermo-Fisher-Scientifics-Olink-Platform-Selected-for-Worlds-Largest-Human-Proteome-Study/default.aspx

HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors. Press release. Centers for Medicare and Medicaid Services. January 17, 2025. 

https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower

Videos

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new Medicare drug price negotiations, and more. 

Behind the Headlines: Sana’s Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More

UK cloud-based, cell and gene therapy (CGT) software platform developer, Autolomous, has partnered with US-based Trenchant BioSystems, a CGT manufacturing platform developer for gene-modified cells, to combine technology platforms. The collaboration, announced on Jan. 20, 2025, will address timelines, costs, and challenges with CGT manufacturing.

Under the partnership, Trenchant will integrate Autolomous’ autoloMATE digital solution into their automated CGT manufacturing platform, which has been designed for distributed manufacturing at appropriate global medical facilities. The collaboration is aimed at delivering the first manufacturing process to the market encompassed in a single compact, fully automated chassis combined with a digital platform that generates automated batch records while capturing manufacturing performance and lot-release data in real time.

“The use of current cell and gene therapy manufacturing practices to deliver therapies to large-scale patient populations in an affordable manner is currently theoretically, but not practically, possible. Without significant changes, manufacturing is too lengthy, labor intensive, and costly to deliver CGTs to patients,” said Jon Ellis, CEO, Trenchant BioSystems, in a company press release (1). “Trenchant has developed a manufacturing platform that can reduce both manufacturing timelines to 2.5 days, and costs by over 80%. This can place CGTs for the first time as first-line therapies. To integrate digitalization into this development is critical, and this is why we have selected Autolomous’ autoloMATE as the most advanced CGT-specific digital platform to enable this transformation for the CGT marketplace.”

Trenchant is currently validating an Alpha Prototype of its platform, which the company said takes a fresh approach to CGT manufacturing. The prototype delivers an accumulated cell processing efficiency across all washing, selection, activation, and transduction steps that results in an eight-fold improvement over current practices. The company’s CGT manufacturing process involves a proprietary cell selection and activation technology, spinoculation, and cell washing technologies that remove the current requirement of 

 expansion of chimeric antigen receptor T (CAR-T) cells, which is a costly and lengthy process to produce clinical doses (2).

Trenchant’s platform was designed with digital integration at its core which is meant to reduce the duration of CAR-T manufacturing and lower the cost of goods and labor, both of which have been barriers to patient access. Autolomous offers its expertise in delivering solutions for the CGT space across an international user base that includes academics, contract development and manufacturing organizations, and biotechs. Trenchant selected Autolomous for this advantage as well as Autolomous’ extensive experience in integrating with systems and devices.

Trenchant expects to release internal performance data on the integrated platforms in the first quarter of 2025, after which data generated by a third party currently manufacturing CAR-T cells for clinical use will be released. Trenchant plans to offer its early access programs by the end of the third quarter of 2026.

“Current costs of CGTs, and CAR-Ts specifically, are way beyond the resources of societies to pay for them. Significant highly qualified labor is required to manufacture, review, and release each CAR-T batch. As a result, digitization is essential for CGTs to realistically realize their dramatic therapeutic potential to provide new solutions for a range of patients with no alternative therapeutic options,” said Alexander Seyf, CEO, Autolomous, in the press release. “Trenchant has now devised a new CAR-T manufacturing modality in its own right that will alter the way CGTs are created. This is why Autolomous has entered a partnership agreement with Trenchant to ensure therapies reach unprecedented patient numbers.”

Trenchant BioSystems and Autolomous Partner to Integrate Automated Cell and Gene Therapy Manufacturing and Digital Solutions

. Press Release. Jan. 20, 2025.
2. Cliff, E. R. S.; Kelkar, A. H.; Russler-Germain, D. A.; et al., High Cost of Chimeric Antigen Receptor T-Cells: Challenges and Solutions. 

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days. 

Trenchant BioSystems Partners with Autolomous to Form Integrated Automated CGT Manufacturing Platform

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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AstraZeneca’s Imfinzi (durvalumab) and Tagrisso (osimertinib) have received positive recommendations from the National Institute for Health and Care Excellence (NICE) for the treatment of lung cancer patients in England and Wales, AstraZeneca announced in a press release on Jan. 22, 2025 (1).

Results from a Phase III trial (CASPIAN) showing that durvalumab, added to standard chemotherapy, provided a clinically significant and sustained overall survival benefit in adults with untreated extensive-stage small cell lung cancer (ES-SCLC) at three years informed NICE’s decision on Imfinzi, according to the release.

“Extensive-stage small cell lung cancer is a devastating diagnosis with a poor prognosis—with fewer than 5% of patients surviving beyond two years,” Meenali Chitnis, MD, consultant thoracic medical oncologist at Oxford University, said in the AstraZeneca press release (1). “Positive data from the CASPIAN Phase III trial marks an important breakthrough, providing clinicians with an effective treatment option of durvalumab with etoposide plus carboplatin or cisplatin.”

Osimertinib was recommended based on data from a separate Phase III trial (ADAURA) that demonstrated statistically significant and clinically meaningful improvement versus placebo. It may be offered as an adjuvant treatment option after complete tumor resection in adults with stage IB to IIIA non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (1).

AstraZeneca said in the press release that the United Kingdom has one of the worst five-year survival rates for lung cancer in Europe, with 70% of cases diagnosed at either stage III or IV, which results in “significantly” poorer outcomes (1).

“This is fantastic news for lung cancer patients,” Tom Keith-Roach, president, AstraZeneca UK, said in the release. “We are proud that these decisions by NICE mean we've had 28 positive recommendations by NICE and the SMC since 2021 across multiple cancer types and stages. This represents another step towards our bold ambition to one day eliminate cancer as a cause of death.”

To that end, Imfinzi was approved by FDA in August 2024, in combination with chemotherapy, for treating adult patients with resectable early-stage (IIA-IIB) NSCLC, just weeks after it and AstraZeneca’s Lynparza (olaparib) were approved throughout the European Union for the treatment of certain patients with primary advanced or recurrent endometrial cancer (2).

Osimertinib (under the Tagrisso brand name), meanwhile, was approved by China’s National Medical Products Administration in June 2024, in combination with pemetrexed and platinum-based chemotherapy, for first-line treatment of adult patients whose tumors have the same deletions or mutations as those mentioned above (3).

1. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.
2. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
3. AstraZeneca. Tagrisso with the Addition of Chemotherapy Approved in China as 1st-Line Treatment for Patients with EGFR-Mutated Advanced Lung Cancer. Press Release. June 26, 2024.

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

Two AstraZeneca Treatments Recommended for Lung Cancer Patients in England and Wales

FDA has issued a warning letter to Sanofi summarizing “significant deviations” from current good manufacturing practice (CGMP) for APIs based on inspections conducted from June 12 to July 9, 2024, at Genzyme Corporation, a subsidiary of Sanofi which acts as a company drug manufacturing facility, in Framingham, Mass. (1). The letter, sent Jan. 15, 2025, amends and replaces one sent Dec. 16, 2024.

In a separate action announced Jan. 21, 2025, FDA placed a clinical hold on active investigational new drug (IND) applications by Thousand Oaks, Calif.-based Atara Biotherapeutics (2). The affected INDs include Ebvallo (tabelecleucel), a monotherapy for adults and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease, and ATA3219, an allogenic CD19-targeted chimeric antigen receptor (CAR)-T-cell therapy for treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.

In Sanofi’s case, FDA said failure to address the deviations—which it said have the end result of adulterating APIs under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act—could result in “regulatory or legal action without further notice,” or for FDA to withhold issuance of Export Certificates, or approval of new applications or supplements. A previous response, delivered on July 29, 2024, was considered to be inadequate, for numerous reasons expanded upon by FDA in its letter.

Chiefly, FDA estimated that 20% of bioreactor runs attempted at the Genzyme facility from January 2022 to July 2024 were rejected for quality failures, including contamination (1).

With regard to Atara, a company press release said the clinical hold for Ebvallo was directly connected to GMP compliance issues previously identified in a third-party manufacturing facility pre-license inspection, which were inadequately addressed (2). Starting materials used in the production of ATA3219 are affected by these issues, even though that drug product is manufactured elsewhere.

“We intend to work closely with [FDA] to address these issues as expeditiously as possible,” said Cokey Nguyen, PhD, Atara president and chief executive officer, in the press release. “We are encouraged with ongoing correspondence with the agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs.”

Sanofi’s partnership with Scribe Therapeutics, which combines Scribe’s proprietary clustered regularly interspaced short palindromic repeats editing technologies with Sanofi’s targeted, non-viral delivery technologies, was reported on Jan. 13, 2025 to have reached a success milestone amid a deal that makes Scribe eligible for payments of more than $1.2 billion total for achieving certain benchmarks (2).

Atara—Ebvallo specifically—was given clearance by the European Medicines Agency to be quality control tested at a Thousand Oaks cell therapy manufacturing facility operated by FUJIFILM, the completion of an expansion of which was announced in November 2024 (4). The FDA action does not affect the FUJIFILM facility (2).

, amended (CDER, January 2025).
2. Atara Biotherapeutics. Atara Biotherapeutics Provides Update on Clinical Programs Related to Ebvallo (tabelecleucel) and ATA3219. Press Release. Jan. 21, 2025.
3. Scribe Therapeutics. Scribe Therapeutics Achieves Milestone for 

 Program in Collaboration with Sanofi. Press Release. Jan. 13, 2025.
4. FUJIFILM. FUJIFILM Diosynth Biotechnologies Celebrates the Expansion Completion at its California Cell Therapy Facility. Press Release. Nov. 20, 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

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

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection. A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.

Click the video above to watch Dr. Margosch answer the following question:

“My company recently had critical incidental findings in several vials during secondary packaging. What can be done to minimize the risk of future market batches containing defective units?”

Dr. Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging, Vetter Pharma-Fertigung GmbH & Co KG

Dr. Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter, a global CDMO specializing in aseptic filling and packaging of injection systems. Margosch holds a degree in food science. He joined Vetter more than 15 year ago and has held various positions in the field of visual inspection and packaging.

Dr. Margosch joined the pharmaceutical service provider Vetter Pharma-Fertigung GmbH & Co KG in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Pharmapack Europe 2025: Packaging Trends

As a preview of what’s to come at this year’s Pharmapack Europe event, being held on January 22–23 in Paris, France, 

 sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the different packaging solutions the company has to offer. The company will be jointly exhibiting with the newly acquired Bormioli Pharma.

 its primary packaging solutions and delivery systems for sensitive biologics, such as its EZ-fill Smart packaging platform for ready-to-fill (RTF) vials and cartridges. Gerresheimer’s Gx Elite syringes, cartridges, and vials offer protection for injectable drugs, especially novel biologics, says the company (1).

Verheyden sees a trend toward at-home therapy and personalized medicine, and Gerresheimer offers autoinjectors and other drug delivery devices to accommodate this trend.

“[Our] devices actually enable a very simple, patient-friendly application with high precision dosing of the respective medication, which I think is very important. And then on top of that, [our] on-body drug delivery device can actually be digitally monitored, which I think for healthcare professionals is also very interesting, because they can pretty easily monitor the patient and how he's actually been fulfilling his treatment,” says Verheyden.

“[Gerresheimer is] becoming an organization that focuses on solutions in specific domains. Yeah, what we want to make sure … we understand what the market needs, and that we anticipate those needs. And therefore, we think it is very important that we understand very well what happens in specific … disease areas, [for example], chronic disease, … repetitive treatments, oncology, all the diseases where we think a more customized product offering could be of an added value,” Verheyden says.

Gerresheimer and Bormioli Pharma can be found at booth F55 at Pharmapack in Paris Expo, Porte de Versailles from Jan. 22–23, 2025.

Click the above video to watch the full interview.

1. Gerresheimer. Two Stories–One Future. Gerresheimer and Bormioli Pharma at Pharmapack 2025. Press Release. Jan. 20, 2025.

Pharmaceutical Technology® sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the primary and secondary packaging solutions Gerresheimer and Bormioli Pharma will be showcasing at Pharmapack Europe 2025 in Paris, France from January 22–23.

The contract development and manufacturing organization Navin Molecular announced on Jan. 15, 2025 that it was making a Rs 10 Crore (approximately US$1.2 million) investment for the purpose of building a 1200-square-meter research and development facility in India, the company’s home country (1). The proposed area to be constructed for the new building equates to almost 13,000 square feet.

In a press release, Navin said the goal of the facility, which will be at its Dewas, India site, is to increase capacity for laboratory and kilo-scale process development and enhance analytical development and testing capabilities, all in the interest of better scale-up of customer products (1).

“Robust and thorough process development is crucial to ensure the chance of successful scale up, and customers are looking for partners that are flexible and have the capacity to take on projects with the minimum of delay to meet their demanding timelines,” said Jordi Robinson, Navin Molecular chief commercial officer, in the release (1). “This expansion will ensure that we can match these expectations, as well as increasing our technology offering through flow chemistry and ozonolysis, ensuring that we can continue to provide the highest quality, cost-effective manufacturing solutions for our customers.”

 video series, discussing the outsourcing landscape in the aftermath of the COVID-19 pandemic (2). In the episode, Robinson and Eric S. Langer of BioPlan Associates discussed changes in the demand for outsourced bioprocessing services, driven by a burgeoning pipeline of clinical-phase therapeutic candidates and the practical need for more advanced analytics.

Navin’s new kilo-scale lab, according to the company, is expected to offer cylindrical vessels of up to 100 liters in volume, mimicking conditions at the company’s production plant (1). An additional, analytical laboratory will also be built. Among some of the other specific equipment that is planned are 48 fume hoods for chemical process development and specialized technology for performing flow reactions and ozonolysis.

In January 2025, among a list of key trends identified for the pharmaceutical industry for 2025, PharmaPack Europe and CPHI said the wait for the BIOSECURE ACT in the United States to be either passed or rejected in some form may result in some discovery chemistry services being switched from the US to contract research organizations throughout Europe as well as in India (3).

The investment announced by Navin, the benefits of which already began in December 2024 with work on the new facility in Dewas, is expected to create up to 65 new jobs—doubling the size of Navin’s R&D team (1). Work is expected to be completed by May 2025.

1. Navin Molecular. Navin Molecular to Expand Process Research and Development Capacity, Adding New Flow Synthesis and Ozonolysis Technologies. Press Release. Jan. 15, 2025.
2. Mirasol, F. 

Drug Digest: Changes and Trends in the Outsourcing Landscape.

, June 7, 2024.
3. Pharmapack Europe. Pharmapack Predictions 2025: the Good the Bad and…. the Donald 2.0. Press Release. Jan. 13, 2025.

The 1200-square-meter facility that is planned will enhance analytical development and testing capabilities to support scale-up of products for customers.

Navin Molecular Expands Process R&D Capacity with New Facility in India

Cytiva and Cellular Origins, a TTP company based in the UK that specializes in advancing scalable and cost-effective cell and gene therapy (CGT) manufacturing, have partnered to combine technology platforms that will offer automated, robotic manufacturing of CGTs, Cytiva announced on Jan. 16, 2025. Under the agreement, Cytiva will combine its automated Sefia platform with Cellular Origin’s Constellation, an automated robotic platform. The integration of these two technologies aims to enable scale-up of CGT manufacturing to industrial levels without changing the initial manufacturing process used during discovery phases or clinical trials, according to a company press release (1).

The two systems are expected to have a seamless interface, which will provide complete digital interconnection. This interconnection will encompass quality control systems, fully remote digital controls, and analytics. The integration will remove the need for manual intervention between and within CGT manufacturing steps. The companies expect that the combined technologies will help drive new standards of automation and manufacturing productivities.

“The manufacturing of cell and gene therapies must evolve from personalized and small batch medicine to industrialization if these therapies are to reach their potential for patients. At Cellular Origins, we are working to make this a reality. By collaborating with Cytiva … we are building a unified automation platform that can meet the sector's large-scale industrial needs,” said Edwin Stone, CEO, Cellular Origins, in the press release (1).

Work is already underway to integrate the platform technologies, and the first systems are set for process and biological testing in early 2025. Good manufacturing practice systems are expected to be available by the end of 2025 for clinical use.

The companies estimate that 47% of referred patients currently get access to chimeric antigen receptor T cell (CAR-T) therapies (2). Current manufacturing practices for CAR-T therapies heavily rely on manual labor, which adds to the complexity and variability of its production process. Meanwhile, limited manufacturing capacity, significant risk of batch failures, and the expected increase of regulatory approvals for wider indications are expected to present more challenges for drug developers to satisfy the growing patient demand.

“Countless patients have benefited from Cytiva's cell processing systems, and we remain enthusiastic about the therapeutic potential of CAR-T. We firmly believe that automating these processes will unlock wider access to these life-changing therapies. The open nature of Cellular Origins’ design fits seamlessly with Cytiva's Sefia platform and potentially benefits a wide array of therapeutic developers. We are excited to see what the combined potential of our collaboration brings to the future of medicine,” said Emmanuel Abate, president Genomic Medicine, Cytiva, in the release.

The companies realize that a modular robotic approach will help manufacturers scale up from thousands to hundreds of thousands of CGT doses per year, according to the press release. With the integration of the two technology platforms into existing customer workflows, those workflows will be enabled to manufacture commercially approved and late-stage CGT products around the clock without the need to change systems or redesign approved processes.

Cellular Origins and Cytiva are Collaborating to Deliver Automated Robotic Manufacturing Capabilities for Cell and Gene Therapies

. Press Release. Jan. 16, 2025.
2. IQVIA. 

Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

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