Zachary Zubulake

Avi Nandi, SK Pharmteco explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

Avi Nandi on Simplifying Cell & Gene Supply Chains

Access Part 1 of this interview on how CDMOs simplify cell & gene therapy supply chains by managing lead times, consistency, and material expiry.

, Avi Nandi, president of SK Pharmteco Cell & Gene North America, shares his perspective on emerging technologies reshaping how cell and gene therapy manufacturers handle media and buffer production.

Nandi speaks on a product showcase focused on simplifying on-site media and buffer manufacturing, a technology designed to bring supply chain control directly to manufacturers and service providers. He sees clear advantages in this approach.

"Having internal control of the supply chain, the manufacture of media and buffers, is a huge benefit," he notes, pointing to the ability to produce materials based on immediate demand while reducing inventory risk, cash exposure, and the threat of expiry when manufacturing schedules shift.

At the same time, Nandi acknowledges that CDMOs face a higher bar for adopting new technologies given the consistency demands of their broad client base. Any variability in media or buffer quality could have downstream consequences that aren't discovered until late in the manufacturing process.

On the topic of sustainability, Nandi offers a nuanced take. Cell and gene therapy is a heavily single-use industry with high consumable use and significant waste, which means sustainability looks different here than in traditional chemical manufacturing.

"The primary lever I would pull is, how do you leverage technologies to then improve productivity to then improve upon sustainability?" he explains. By maximizing productivity and reducing the number of manufacturing runs Avi Nandi, SK Pharmteco, companies can make meaningful environmental gains.

Videos

Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

Todd Vaughn and Christa Myers, CRB, discuss how Robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

Todd Vaughn and Christa Myers on What Robotics Mean for Pharma Manufacturing

rising automation in aseptic manufacturing and growing regulatory focus on sterility.

, Todd Vaughn and Christa Myers, Fellows of Aseptic and Sterile Products at CRB, speak with 

to discuss their panel discussion on the growing role of robotics and automation within the aseptic core of pharmaceutical manufacturing. Their conversation covers where the industry stands today, the opportunities automation presents, and what challenges lie ahead.

Both speakers highlight environmental monitoring, specifically, the automated handling of plates and monitors. As Myers notes, "Every time you stick your hand in a glove to change a plate, which sometimes happens every hour, sometimes happens every two hours, you have to stop your fill line, which means you have to stop production, which means you have to stop manufacturing." Automating this step, she argues, could significantly restore efficiency to fill lines and should have been done years ago.

Beyond environmental monitoring, both emphasize the value of robotics in equipment setup and component handling, citing improved repeatability and reduced reliance on human consistency. However, they are clear that automation doesn't mean fewer people; it means different people with different skills. Operators will need deeper technical knowledge, including mechanical and electronics training, while upstream areas like component prep and sterilization may actually require more staff.

Regulatory expectations are also shifting. As Todd Vaughn states, "Continuous improvement is what's expected now" and operators must be prepared to track trends and demonstrate risk mitigation when regulators come calling. Looking ahead, Vaughn describes the industry as being "right on the edge of novel use to expected use," anticipating that older lines could soon face scrutiny as fully automated systems become the new standard. Vaughn and Myers stress that the industry must also find ways to bring smaller, less-capitalized companies along for this transition, because their contributions to patients remain just as vital.

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

Richard Sanderson, IPS, discusses pharma capital project cost pressures, bloated deliverable lists, and making the case for EPCM's end-to-end delivery model.

Richard Sanderson on EPCM vs. Construction Firms

Richard Sanderson, vice president in the Project Business Services group, IPS, sat down with 

 on deploying lean, sustainable, and tech-enabled delivery platforms on large engineering, procurement and construction management

EPCM) projects. In this part 1 of a two-part interview, he reflects on the evolving pressures facing pharmaceutical capital project teams and how IPS is responding. 

Sanderson identifies cost reduction as the defining trend shaping the industry. Large branded pharma clients are increasingly looking to CDMO and CMO organizations for inspiration, seeking to adopt their leaner ways of working. Beyond operational changes, procurement groups are playing a more active role, exploring alternative contracting models, including limited agency agreements, and in some cases choosing to hold contracts directly rather than through an EPCM partner to eliminate associated fees.

Sanderson highlights the issue of bloated deliverable libraries. "Over a period of time, [pharma clients] have built up a large library of deliverables that they expect during the engineering phase, and quite frankly, the extent of some of these lists of deliverables is really, really large and not fit for purpose," he says, adding that IPS must engage clients early to right-size these expectations and arrive at a leaner, more practical set of requirements.

On the merits of the EPCM model itself, Sanderson is confident in its advantages, particularly the ability to overlap design, construction, and compliance phases to compress timelines. However, he acknowledges a persistent perception problem. "Some clients don't view the EPCM firms like IPS as real builders," he notes, adding that while IPS has strong construction capabilities, the company must work harder at the proposal stage to prove it can deliver the full end-to-end scope as effectively as dedicated construction management firms.

FDA Approves Triple Therapy Inhaler for Asthma

On April 28, 2026, AstraZeneca's fixed-dose triple-combination inhaler Breztri Aerosphere received FDA approval for the maintenance treatment of asthma in adults and pediatric patients aged 12 and older.

 The approval marks the product's second approved indication after its 2020 clearance for chronic obstructive pulmonary disease in adults. The approval makes Breztri the only single-inhaler triple therapy available for asthma in the US.

Breztri combines budesonide, glycopyrrolate, and formoterol fumarate delivered via the Aerosphere pressurized metered-dose inhaler.

 The platform required solving non-trivial particle engineering and suspension stability challenges to co-formulate 3 active substances with distinct physicochemical properties. The COPD formulation, approved at a slightly different dose (320/18/9.6μg), has been prescribed to more than 6.8 million patients globally as of 2025, providing a substantial real-world dataset on the inhaler's performance and patient handling.

What Did the Clinical Program Demonstrate, and Why Does it Matter for Development Teams?

The approval was based on the Phase III KALOS and LOGOS trials, replicate confirmatory, randomized, double-blind studies enrolling approximately 4,300 patients across 24-to-52-week variable-length treatment periods.

 The trials compared Breztri against dual-combination corticosteroid/long-acting beta2-agonist therapy, both a marketed reference product (Symbicort) and a formulation-matched comparator (budesonide/formoterol fumarate in the same Aerosphere device), allowing regulators to isolate the contribution of the added long-acting muscarinic antagonist component.

The primary endpoint in the US regulatory submission was change from baseline in forced expiratory volume in 1 second area under the curve from 0 to 3 hours at week 24, with trough forced expiratory volume at week 24 as the key secondary endpoint.

 Results published in The Lancet Respiratory Medicine in February 2026 showed statistically significant and clinically meaningful improvements in lung function versus the dual-therapy comparators. A secondary finding was a measurable improvement in lung function within five minutes of the first dose. No new safety or tolerability signals were identified relative to the established COPD profile/

Njira Lugogo, MD, clinical professor in the Division of Pulmonary and Critical Care Medicine, the University of Michigan, describes in a press release,

 "Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms. The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner."

What Are the Implications for the Broader Respiratory Pipeline?

Asthma affects an estimated 262 million people worldwide, including 27 million in the US, and approximately half of those patients remain inadequately controlled on dual therapy.

 The unmet need is well characterized, persistent bronchoconstriction, exacerbations, and reduced quality of life, and the regulatory pathway now established for triple therapy in asthma offers a clearer precedent for development teams pursuing similar combinations.

Breztri is currently approved for chronic obstructive pulmonary disease in 90 countries, and regulatory submissions for the asthma indication are under review in the EU, Japan, and China, each of which will require additional technical packages aligned to regional expectations.

Ruud Dobber, executive vice president of the BioPharmaceuticals Business Unit, AstraZeneca, noted in the press release,

 "As the fastest growing fixed-dose triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients. The FDA's approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases."

How Does AstraZeneca's Respiratory Approval Fit its Broader Immunology Pipeline?

The Breztri asthma approval arrives alongside related regulatory activity elsewhere in AstraZeneca's portfolio.

 The FDA approved a subcutaneous self-administration option for Saphnelo (anifrolumab), the company's first-in-class monoclonal antibody for systemic lupus erythematosus, via a once-weekly autoinjector called the Saphnelo Pen. That approval was supported by the Phase III TULIP-SC trial, published in Arthritis & Rheumatology in January 2026, which demonstrated statistically significant reductions in disease activity versus placebo. The back-to-back approvals, one an inhaled fixed-dose combination, the other a subcutaneous autoinjector, illustrate the continued investment in device development by one of Pharma’s largest firms.

AstraZeneca. BREZTRI approved in the US for asthma. Published April 28, 2026. Accessed April 28, 2026. 

https://www.astrazeneca.com/media-centre/press-releases/2026/breztri-approved-in-the-us-for-asthma.html

AstraZeneca. SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. Published April 27, 2026. Accessed April 28, 2026. 

https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-approved-in-the-US.html

Articles

FDA approval extends Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) to maintenance asthma therapy for adults and adolescents ≥12 years, making it the only US single-inhaler triple therapy for asthma. Replicate Phase III KALOS/LOGOS trials (~4,300 patients) demonstrated statistically significant, clinically meaningful FEV₁ improvements versus ICS/LABA comparators, including rapid onset within minutes, without new safety signals versus the established COPD profile. The milestone establishes a clearer regulatory precedent for triple-combination asthma development amid persistent dual-therapy inadequacy.

FDA approves AstraZeneca's Breztri as the first single-inhaler triple therapy for asthma in patients 12+, a new precedent for respiratory drug developers.

FDA Approves Breztri as First Triple Therapy Inhaler for Asthma

Leslie Weaver and George Hunt, IPS, discuss early sustainability and lean alignment in pharma construction that reduce costs, absorb disruptions, and keep projects on schedule.

Leslie Weaver and George Hunt On Lean and Sustainability in Pharma Construction

George Hunt, corporate lean director at IPS, and Leslie Weaver, sustainability project manager at IPS, discuss the importance of early planning, strategic alignment, and lean methodology in Part 1 of a two-part interview with 

Both Hunt and Weaver emphasize that sustainability considerations must be introduced at the very start of a project. As Weaver explains, "The later you wait to bring sustainability into the mix, the more your window of opportunity closes." Early decisions, such as site location, building orientation, and long-lead equipment selection, are critical moments that, if missed, can lead to costly redesigns and delayed procurement down the line.

From a lean perspective, Hunt argues that early alignment goes beyond sustainability alone. It encompasses business goals, budget, schedule, and how the project team will function together. "Having that early alignment really does a great job and sets the groundwork to be able to operate efficiently together," Hunt notes. In lean terminology, these shared objectives are called conditions to satisfaction, serving as a North Star that keeps all stakeholders moving in the same direction throughout the project lifecycle.

The pair also address the unique challenges of working within pharmaceutical environments, where regulatory requirements can complicate sustainability goals. Their approach is to first understand the constraints and the reasoning behind them, then find solutions that honor both compliance and environmental objectives.

Hunt closes with a concrete example of a schedule-driven pharmaceutical project where lean principles were applied from design through commissioning and validation. While an equipment issue outside the team's control prevented an early finish, the lean approach allowed the team to absorb that disruption without pushing the overall schedule. As Hunt explains, "Lean helps us take a look at that, operate differently, and be able to absorb it."

Leslie Weaver and George Hunt on Lean and Sustainability in Pharma Construction

Ryan Kelly, Rx360, explains how third-party audits and integrated quality-supply chain strategies protect pharma supply chains and patient safety.

Ryan Kelly on Smarter Pharma Supply Chain Audits

Ryan Kelly, interim CEO and senior director of supply chain security and brand protection at Rx360, discusses how the pharmaceutical industry is rethinking the relationship between quality and supply chain management in Part 1 of a two-part interview with 

A key part Rx360’s work involves third-party auditing, which Kelly argues offers a distinct advantage over internal audits. As he explains, "Sometimes if it's your own internal organization, it may be a little challenging to call a baby ugly." By coming in as an outside party, Rx360 can surface issues that might otherwise go unaddressed, remediate them through CAPA, and ultimately reduce how often audits need to happen. 

Kelly also spoke to a broader cultural shift underway in the industry. Traditionally, quality and supply chain have operated as separate functions, with quality focused on manufacturing and batch release and supply chain focused on logistics and execution. Rx360 is working to break down that divide. As Kelly states, "The way that I move product through the supply chain, maintaining temperature, maintaining visibility, maintaining control of that product all through the supply chain, that's gonna impact quality."

On the audit side, Kelly flagged a common blind spot: companies that believe they have supplier redundancy but actually don't. If a primary and secondary supplier are drawing from the same source, a single disruption can expose the entire supply chain. His advice is to map your supply chain thoroughly, understand every tier of your supplier base, and assess geographic, regional, financial, and logistical risks. Quality, he emphasizes, can't be added after the fact, it has to be designed in from the start.