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This week's headlines saw oncology investment; persistent pressure on supply chain resilience and drug availability; and the importance of operational readiness.

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Behind the Headlines Episode 28

A top view of medicine powders, liquids in containers, and various manufactured medicine on the American flag. An America pharmaceuticals concept. | image Credit: ©Ming -stock.adobe.com

On July 10, 2026, the FDA announced a proposed rule to streamline registration for single distributed manufacturing establishments that operate using a “hub-and-spoke” model.

 The proposed rule would create a streamlined pathway and clarify registration requirements for certain foreign companies that manufacture APIs and drug products that indirectly enter the US drug supply. In addition, it would help reduce registration costs and generate efficiencies, according to the agency.

Currently, distributed manufacturing establishments use a central quality oversight hub with multiple manufacturing units in different locations and must register each of those units with the FDA separately. The new rule would allow the establishment to register as one unit.

Certain foreign drug manufacturing companies, such as those not registered with the FDA that distribute to other foreign establishments, would see registration and drug listing requirements clarified under the rule. “By aligning our regulations to the statutory requirements, this proposed rule would make it clearer that these establishments must register with the FDA and report on the drugs they produce, giving the FDA greater ability to detect and respond to potential safety concerns,” the agency stated in the press release.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works—as one single establishment,” said Michael Davis, MD, PhD, acting director of FDA’s Center for Drug Evaluation and Research, in a press release.

 “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”

Because each unit in a distributed manufacturing network currently has to register separately with the FDA, this complicates administration for those companies that run a central quality hub with multiple production units. This proposed rule would provide a single-registration pathway, and the network could register as one establishment, allowing for a streamlined process for adding, relocating, and removing units. This change would support newer manufacturing models such as modular and continuous manufacturing operations. However, companies would be required to give the FDA advanced notice of any unit relocations.

The rule may close a registration gap for some foreign manufacturers of APIs and other drug components, allowing for broader supply-chain transparency and traceability upstream. Currently foreign facilities that make drug components solely for further distribution to other foreign establishments have been able to avoid registration in the United States, because the product never directly enters the US supply chain at that stage.

“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” said Dr. Davis in the press release.

 “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Because this rule could cut registration overhead once finalized, any company sourcing APIs or intermediates from foreign suppliers that currently sit outside the registration net should expect those suppliers to face new registration/listing obligations, which could affect supply chain audits and sourcing decisions.

The Link Between Ingredient Suppliers and the Supply Chain

If this new rule impacts suppliers, it could impact a supply chain that is already strained, but it could also help protect it. The drug supply chain may be disrupted by a variety of factors, such as geopolitical impacts, manufacturing quality deficiencies, and a breakdown in ingredients supplies. If a drug is in shortage, patients cannot get the treatment they need.

The US Pharmacopeia released their annual drug shortages report in June 2026, which found that while shortages were down, they were lasting longer.

“More than half (64%) of the drugs in shortage have been in shortage for more than 3 years, with 29 (39%) drugs being in shortage for more than 5 years,” the report states.

 “Increased durations of drug shortages are a critical public health risk that can lead to compromised patient care, treatment delays, and unfavorable outcomes. Without intervention, prolonged shortages will continue to directly burden patients and healthcare providers.”

And generic drug manufacturers were specifically impacted.

“Manufacturers of generic drugs and their ingredients operate on thin, sometimes unsustainable margins,” said Matthew Christian, director of Supply Chain Insights at USP, in the press release.

 “This report shows a relationship between prices received by manufacturers and continued production. Product discontinuations add to supply fragility and risk of future shortages if supply cannot meet demand.”

PharmTech spoke with Gabriela Grasa Mannino

, senior director, Advanced Supply Chain Solutions at USP about the current state of the drug supply chain and what actions USP is taking to make supply more secure.

“The nature of supply chain risks has also changed, as they are no longer exclusively episodic. We have moved from disruptions driven by isolated events to a more persistent, systemic level vulnerabilities,” Mannino told 

 “Today, manufacturers operate in a more dynamic and less predictable environment, where disruptions are harder to anticipate and increasingly complex to manage. Looking ahead, these challenges are likely to persist, especially for products that rely on concentrated or highly specialized production. This really reinforces the need to address the underlying system, not just react to the outcomes.”

FDA proposes rule to modernize drug manufacturing registration. FDA. Press release. July 10, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration

USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. 

https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk

Mannino GG, Haigney S. The role of standards in the drug supply chain. 

https://www.pharmtech.com/view/the-role-of-standards-in-the-drug-supply-chain

Articles

FDA proposed a rule enabling “hub-and-spoke” distributed manufacturing networks to register as a single establishment rather than registering each manufacturing unit separately. The approach aims to reduce administrative burden, better reflect centralized quality oversight, and support modular and continuous manufacturing, while requiring advance notice for unit relocations. The proposal also clarifies registration and drug-listing expectations for certain foreign API and component manufacturers that have historically sat outside FDA registration. Expanded upstream transparency may influence supplier qualification, audits, and sourcing amid prolonged drug shortages and fragile generic economics.

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments. 

The FDA Moves to Modernize Drug Manufacturing Registration

Sarclisa Escena is subcutaneous injection designed for 3 multiple myeloma treatment combinations

On July 9, 2026, the FDA approved Sarclisa Escena (isatuximab-irfc) for subcutaneous injection across three multiple myeloma treatment combinations, adding a delivery option to an anti-CD38 monoclonal antibody that had previously been available only as an intravenous infusion.

 Isatuximab-irfc with pomalidomide and dexamethasone is approved for adult patients who have received at least 1 prior line of therapy that included lenalidomide and a proteasome inhibitor. Isatuximab-irfc with carfilzomib and dexamethasone is approved for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone is approved for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

Efficacy of subcutaneous isatuximab-irfc with pomalidomide and dexamethasone was evaluated in IRAKLIA, an open-label, non-inferiority trial that randomized 531 patients evenly between subcutaneous administration, delivered through an on-body delivery system, and intravenous administration.

 Overall response rate reached 71.1% in the subcutaneous group and 70.5% in the intravenous group, meeting the trial's non-inferiority threshold for that endpoint. A pharmacokinetic comparison also found that subcutaneous dosing produced higher steady-state trough drug concentrations than the intravenous formulation, with a geometric mean ratio of 1.53.

Two additional single-arm studies supported the other indications. In IZALCO, a phase 2 trial of the combination with carfilzomib and dexamethasone in 74 patients with relapsed or refractory disease, overall response rate was 79.7%.

 In IsaSocut, an investigator-sponsored phase 2 study of 74 transplant-ineligible patients with newly diagnosed disease receiving isatuximab-irfc alongside bortezomib, lenalidomide, and dexamethasone, overall response rate reached 97.3%.

The prescribing information carries warnings for hypersensitivity and other administration-related reactions, neutropenia, infection, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.

 The recommended dose is 1400 mg, given subcutaneously either through the on-body delivery system or by syringe with a manual infusion set.

Why Does This Approval Matter Beyond the Clinic?

This approval is another data point in the industry's ongoing shift toward subcutaneous formulations for monoclonal antibodies originally built as intravenous infusions.

 That shift carries real technical demands: high-concentration formulation work needed to fit a therapeutic dose into an injectable volume, device engineering for wearable delivery systems, and analytical characterization of how absorption and exposure differ from the intravenous route.

The change also reshapes site-of-care logistics.

 Administration times measured in minutes rather than hours reduce chair time in infusion centers and open possibilities for at-home or community-based dosing. Warnings for hypersensitivity and other administration reactions still apply to the subcutaneous route, meaning monitoring protocols built around the intravenous formulation need to be reassessed. The FDA's willingness to rely on non-inferiority efficacy data paired with pharmacokinetic bridging data, rather than requiring new large-scale outcome trials, also illustrates how switching studies for reformulated biologics are increasingly being reviewed and accepted.

The application was supported by orphan drug designation and reviewed using the FDA's Assessment Aid, a voluntary submission format intended to streamline oncology review.

What Does the On-Body Injector Add to the Administration Picture?

The subcutaneous approval also introduced device-specific detail relevant to administration burden.

 Sarclisa Escena's on-body injector (OBI), built on Enable Injections' enFuse platform, delivers the drug hands-free through a retractable 30-gauge needle designed for high-volume dosing. In the IRAKLIA trial, systemic administration reactions occurred in 1.5% of subcutaneous patients compared with 25% receiving intravenous dosing, while injection site reactions affected 0.4% of injections, nearly all low grade. As Sikander Ailawadhi, principal investigator of the IRAKLIA study, noted in a press release,

 “The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa's consistent efficacy.”

FDA approves isatuximab-irfc subcutaneous injection for multiple myeloma indications. U.S. Food and Drug Administration. Press Release. July 10, 2026. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. Sanofi. Press Release. July 10, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483

FDA approval expanded isatuximab to a subcutaneous formulation (Sarclisa Escena; isatuximab-irfc) across three myeloma regimens spanning transplant-ineligible newly diagnosed and relapsed/refractory settings. A non-inferiority randomized study supported the pomalidomide/dexamethasone combination, showing comparable ORR to IV dosing and higher steady-state trough exposure with SC delivery. Two single-arm phase 2 studies supported approvals with carfilzomib/dexamethasone and with VRd. The label retains key class warnings and specifies 1400 mg SC via on-body injector or manual set.

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

The Implications of Isatuximab-irfc’s FDA Approval for Multiple Myeloma

PharmTech Weekly — July 10, 2026

This week, regulators, dealmakers, and manufacturers converged on the same demand: greater accountability and resilience across drug development and manufacturing. From phased and accelerated regulatory reviews, to enforcement on artificial intelligence (AI)-assisted documentation, to acquisitions built to close capability gaps, the pressure is on to build systems that are faster, better controlled, and more transparent.

In regulatory news this week, the European Medicines Agency’s (EMA’s) 

 for metastatic pancreatic cancer previews how legislative reform for pharmaceuticals in the European Union may help regulators assess quality and clinical data in stages, compressing timelines without lowering the evidentiary bar.

, the first dual BAFF and APRIL inhibitor for IgA nephropathy, highlights the pairing of self-administered specialty biologics with near-term confirmatory data requirements.

, worth up to $1.5 billion, is the next in a string of deals showing that payload and linker chemistry, not just antibody targeting, are driving competitive differentiation in next-generation ADCs.

And finally, Teva and Polpharma Biologics’ 

 biosimilar expands access to specialized biologics in the multiple sclerosis market.

Industry experts took a look at a variety of topics this week on 

 explained how the FDA’s warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting of good manufacturing practice (GMP) documents still requires quality-unit review, controlled source material, and process validation performed by experts.

 explained that drug shortages often stem from geographic concentration and quality variability, and that standards paired with data-driven risk assessment are key to building supply chain resilience.

 about the role of variability in patient-derived starting material. The experts suggested that variability can’t be standardized away and requires risk-based control strategies and clinically representative data to keep autologous manufacturing robust.

 argued that patient-centered formulation, 3D-printed dosage forms, and AI-driven development are coming together to make personalized, preventive medicine achievable, as long as the underlying data are well managed.

Contract research organizations are being encouraged to replace manual, disconnected workflows with automation and integrated systems, because efficiency and data integrity define competitive advantage, 

, Lonza Capsugel’s Jamie Evans and Joe Cobb emphasized that successful sponsor-to-CDMO technology transfer depends on rigorous gap analysis, quality-by-design planning, and strong governance to avoid regulatory and supply delays.

The message from industry experts and regulators is consistent this week: speed and innovation only hold up when they’re backed by rigorous control, data, and collaboration.

Videos

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

PharmTech Weekly Roundup–July 10, 2026

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

regulatory actions are coming together in an effort to move biologics, the gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, Parexel.

Q. My company manufactures biologics, and we saw some recent actions by FDA, USP, and the EU. ow do these regulatory actions impact us as a biologics manufacturer?

A. The US Pharmacopeia (USP) has released methods for biologics, without specifications, in an effort to help biologic manufacturers, because this is a rapidly growing field. So, this should help people in terms of their chemistry, manufacturing, and controls (CMC) sections, with methods, and then they can set the specifications depending on the product they're developing.

The European Medicines Agency (EMA) announced an agreement for their Critical Medicines Act that came out in 2025. This act addresses controlling drug shortages and eliminating some of those roadblocks like suppliers, because there may be critical elements that a company needs to manufacture a biologic that might be available from only one source; if that supplier has a problem, everybody has a problem.

The other recent action is from the FDA. The agency put out a draft guidance about leveraging prior knowledge in the development of human gene therapy products incorporating genome editing. The guidance says that, instead of establishing your own holistic platform, you can reference studies and information that have been published to enhance your CMC section or your filing.

These regulatory documents are open for public comment, and companies should consider submitting their comments and/or concerns, including the USP standards.

Let’s discuss the potential intentions of the regulators in taking these actions. These products are typically life-saving products, when we look at biologics. These are products that not only the patients want to see urgently, but also the regulators are supporting the industry in getting them to market.

But not only that, there is a supply chain behind it because you cannot make everything in-house. You need suppliers. And it may be for some of these raw materials and excipients, they may be very difficult to get hold of. And some may be very difficult to transport. So, there are many different aspects to this. And some of the technical ideas are to perhaps manufacture close to where your patients are.

Because the knowledge of these products may be limited to a few people or a few firms, the FDA draft guidance is trying to expand that knowledge by allowing companies to use information that's previously been published for their product, to be able to expedite approval of these lifesaving methods.

And coming back perhaps also to the manufacturing; you could, for example, traditionally file for a product in the United States, and then you file in Europe and maybe other jurisdictions. And you may typically have a product that you start making in the US, and then you ship it over to other markets. That's not always an option with biologics, especially because cell and gene therapy products may not be conducive to such shipments.

And something that all the regulators like to see now is to have manufacture much more within the market where they are regulating, which may mean, with this distributed manufacturing, that we are probably getting away more and more from the centralized large production facilities to more smaller, closer to the patient facilities where we have shorter supply chains.

But how do we get all our suppliers to supply us to these locations rather than to just one? So, there are many aspects that need to be considered. It's important that companies provide their input to the regulators because they want to hear what is feasible and what is practical.

USP publishes product-specific emerging biologics standards for public comment. USP. Press release. June 1, 2026. Accessed July 9, 2026. 

https://www.usp.org/news/usp-publishes-product-specific-emerging-biologics-standards-for-public-comment

EMA welcomes political agreement on the Critical Medicines Act

. EMA. News release. ec.europa.eu. May 12, 2026. Accessed July 9, 2026. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1017

FDA issues draft guidance to help accelerate cell and gene therapies for patients. FDA. Press release. June 2, 2026. Accessed July 9, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-help-accelerate-cell-and-gene-therapies-patients

USP has issued product-specific analytical methods for emerging biologics without predefined specifications, enabling sponsors to tailor acceptance criteria while strengthening CMC packages. In Europe, the EMA-backed Critical Medicines Act targets shortage prevention and supply-chain resilience, particularly where single-source inputs create systemic vulnerability. FDA’s draft guidance on genome-edited gene therapies encourages leveraging published prior knowledge to expedite CMC development and regulatory review. Collectively, these actions support faster patient access and push manufacturing toward more distributed, in-market models. Public comment is actively solicited.

Three regulatory actions are coming together in an effort to move biologics, the gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, Parexel.

Regulatory Actions Impacting Biologics

Teva Pharmaceutical Industries and Polpharma Biologics Collab on Ocrevus (ocrelizumab)

On July 9, 2026, Teva Pharmaceutical Industries and Polpharma Biologics International have entered a global licensing agreement covering a proposed biosimilar to Ocrevus (ocrelizumab), a biologic used to treat multiple sclerosis.

 The agreement grants Teva exclusive rights to commercialize both the intravenous and subcutaneous formulations of the biosimilar candidate, contingent on regulatory approval in each market where it is introduced.

Ocrelizumab is a humanized monoclonal antibody designed to target immune cells believed to play a role in the autoimmune activity associated with multiple sclerosis.

 The reference product, Ocrevus, is approved for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. In the United States, the intravenous version is sold as Ocrevus, while the subcutaneous version is marketed separately as Ocrevus Zunovo. In the European Union, both formulations carry the Ocrevus name.

Under the terms of the agreement, Polpharma Biologics retains full responsibility for developing and manufacturing the biosimilar candidate, working with outside development and manufacturing partners.

 Teva will handle regulatory submissions and, if the product is approved, its commercialization in the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey.

Why Does This Deal Matter for Biosimilar Development?

Multiple sclerosis is a chronic, progressive disease of the central nervous system in which the loss of myelin disrupts the transmission of nerve signals, producing symptoms such as fatigue, walking difficulty, spasticity, dizziness, and vision problems.

 Biologic therapies like ocrelizumab have become central to managing the disease, but their cost and manufacturing complexity keep barriers to access high. A biosimilar that reaches the market could ease some of that pressure once patent and regulatory exclusivities allow entry.

The arrangement also illustrates how biosimilar programs come together: one company focuses on cell line development, process design, and quality assurance, while a partner contributes regulatory expertise and commercial infrastructure.

 This division lets a specialized biologics developer concentrate on matching a reference product's structure and function, while a larger pharmaceutical company applies its established relationships with regulators and health systems across regions. The subcutaneous formulation adds further complexity, because it typically requires reformulation and device development beyond what an intravenous product demands.

How Does This Fit into Teva's Broader Strategy?

Teva has described the agreement as part of its Pivot to Growth strategy, under which the company is expanding its biosimilars portfolio through partnerships rather than relying solely on in-house development.

 “This agreement is aligned with Teva's Pivot to Growth strategy and our focus on expanding our biosimilars pipeline. With our global commercial footprint and deep expertise in complex medicines, we are well positioned to help bring this biosimilar candidate to patients,” said Yolanda Tibbe, vice president and Global Head of Biosimilars, Teva, in a press release.

No financial terms of the agreement were disclosed, and no timeline for regulatory review or potential launch was provided.

 As with other biosimilars in development, the candidate's path to market will depend on generating analytical and clinical data that demonstrate it matches the reference product in structure, function, safety, and effectiveness, the standard regulators require before granting approval.

How Does This Deal Fit into the Broader Biosimilar Landscape?

The Ocrevus biosimilar candidate joins a crowded field; industry trackers now count more than 60 companies and 75 drugs across the multiple sclerosis competitive landscape, spanning marketed therapies, pipeline programs, and inactive projects.

 Polpharma Biologics brings prior experience to this space: the company also developed Tyruko, a biosimilar to natalizumab that became the first biosimilar approved in the US for relapsing forms of multiple sclerosis, commercialized through a separate partnership with Sandoz, a division of Novartis. That precedent suggests a similar regulatory and commercial path may be possible for the ocrelizumab candidate, though clinical review will ultimately decide the outcome.

Teva and Polpharma Biologics announce global licensing agreement for a biosimilar candidate to Ocrevus® (ocrelizumab) for multiple sclerosis. Press Release. July 9, 2026. 

https://www.tevapharm.com/news-and-media/latest-news/teva-and-polpharma-biologics-announce-global-licensing-agreement-for-a-biosimilar-candidate-to-ocrevus-/

Multiple sclerosis competitive landscape. Research and Markets. January, 2026. 

https://www.researchandmarkets.com/reports/6219907/multiple-sclerosis-competitive-landscape

Teva and Polpharma Biologics established a global licensing agreement for a proposed ocrelizumab biosimilar spanning both IV and SC formulations, contingent on regulatory approvals. Polpharma will lead development and manufacturing with external partners, while Teva manages regulatory filings and commercialization across major markets including the US and EU. The program underscores access pressures driven by high-cost, complex MS biologics and highlights typical biosimilar partnering models that pair technical CMC capabilities with global regulatory and commercial scale.

Ocrelizumab biosimilar for multiple sclerosis: Teva and Polpharma Biologics sign global deal covering intravenous and subcutaneous forms.

What the Ocrelizumab Deal Does for the Multiple Sclerosis Biosimilar Pipeline

Jamie Evans is manager of analytical method development and validation at Lonza Capsugel.

Joe Cobb, CPIP is manager of formulations at Lonza Capsugel.

Online documentation database; document management system DMS concept. FTP (File Transfer Protocol), Secure FTP. Internet cloud technology, exchange information and data storage concept. | Image Credit: ©Irene -stock.adobe.com

Technology transfer is a crucial component for sponsors and contract development and manufacturing organizations (CDMOs) alike when collaborating on the development and/or manufacture of pharmaceuticals. To ensure that a tech transfer follows good manufacturing practice guidelines and is successful, a risk assessment and gap analysis should be performed to identify missing data and characterize process parameters, according to Joe Cobb, CPIP, manager of formulations at Lonza Capsugel. Jamie Evans, manager of analytical method development and validation at Lonza Capsugel, describes how alignment with regulatory expectations can be achieved by analytical method transfer, pre-validation evaluations, and optimization.

Fostering productive sponsor-CDMO relationships is important, and this can be done through project managers, escalation policies, joint steering committees, and the coordination of regulatory and operations teams, according to Cobb and Evans. 

 spoke with Cobb and Evans to find out more about how tech transfer can be optimized.

PharmTech: How does a sponsor organization structure the technology transfer package when handing off a manufacturing process to a CDMO. What documents do you consider non-negotiable, and how do you ensure the receiving site can independently reproduce the process?

The CDMO and outsourcing market continues to grow at about 8-10% annually from 2024-2029 as pharmaceutical companies look for additional infrastructure and specialized manufacturing expertise. While outsourcing can help companies mitigate risk and accelerate timelines, technology transfer remains a critical phase that can introduce several challenges.

When working with new customers, the tech transfer package typically includes a bundle of critical documents and manufacturing records needed to advance the drug product into the next phase of development. We review the full package, including the supporting literature and data provided, and conduct an internal risk assessment. The risk assessment leads to a gap analysis that helps us identify any missing information in the customer’s technology package early in the project, as key details are often incomplete or unavailable at the outset.

Through this analysis, we identify the critical quality attributes and apply a quality-by-design (QbD) approach that supports regulatory readiness and development through commercialization. This creates a strong foundation for the project by establishing a quality target product profile that can guide the drug product as it progresses into later stages of development.

How does one handle gaps in process understanding discovered during transfer (e.g., a critical process parameter that wasn't adequately characterized at the sending site)?

Conducting a gap analysis is essential to uncover any missing details and can be managed through risk assessment, process control strategies, and strict change control management.

New technologies, such as compaction simulation, have been more recently introduced to mimic full-scale conditions and allow formulation scientists to explore feasibility earlier in the process. Compaction simulation is designed to evaluate formulations in small quantities to predict compression performance in both dry granulation by roller compaction or in tablet presses. This approach allows for minimal material consumption, guidance in excipient selection, and data-driven decisions for scale-up activities. This technology, combined with the appropriate control strategies, helps provide more accurate assessments to inform formulation and process selection in later stages of development.

Analytical method transfers are often a significant source of delay and failure in tech transfer programs. What is a good approach for qualifying analytical methods at a receiving contract laboratory. How do you define equivalence, and what do you do when method performance doesn't meet acceptance criteria at the new site?

Analytical method transfers require careful planning to ensure consistent performance across sites, which is why a structured method gap assessment is so important. We use that assessment to identify potential issues early, beginning with a detailed review of the method and any associated validation reports provided by the sending unit.

During this review, we look for differences between the sending and receiving sites, including instrumentation, materials, operating conditions, and laboratory practices. Identifying those differences up front allows us to define mitigation steps before they affect the transfer.

Before initiating the formal transfer, we also conduct pre-validation or pre-transfer evaluations of the method to confirm that performance at the receiving site aligns with what the client has reported. These evaluations help determine whether the method can meet the proposed acceptance criteria under receiving-site conditions.

If the method performs as expected, we can move forward with greater confidence. If it does not, we can recommend optimization before initiating the formal transfer protocol, reducing the likelihood of downstream delays or transfer failures.

Have you ever had a situation where the method itself needed to be revised during a transfer rather than just the site qualification? How did you manage that from a regulatory perspective?

At Lonza Capsugel, we evaluate whether a method is not only phase appropriate, but also suitable for quality control and long-term product lifecycle monitoring. In many cases, we receive a method, conduct a detailed assessment, and define an optimization plan before moving forward with transfer activities.

If the method does not yet meet the requirements for routine quality control, we pause transfer activities until it reaches an acceptable state. This helps ensure the method can support reliable monitoring across the lifecycle of the program. From a regulatory perspective, our approach is aligned with FDA expectations and global International Council for Harmonisation (ICH) guidance, which are reflected in our internal procedures. Our regulatory team also actively monitors updates to guidance, so our processes remain current.

How can sponsor companies maintain meaningful technical oversight without creating an adversarial dynamic or micromanaging the CMO's operations? What governance mechanisms, such as joint review boards, data sharing cadences, or escalation paths, work well?

Successful technology transfer depends on treating the sponsor-CDMO relationship as a true partnership rather than a transactional service. From the start of a partnership with a drug sponsor, we establish processes that move the relationship beyond a transactional service model and toward true collaboration. This helps create open communication channels, shared understanding and clear expectations as the drug product progresses through development.

 To support that collaboration and governance structure, our project managers serve as the primary point of contact for customers, ensuring information flows through a clear and consistent channel. We also maintain an escalation policy that iscloselyconnected to our project management structure.In addition, a joint steering committee brings together members of our site leadership team and the sponsor’s team to support alignment, decision-making, and issue resolution throughout the project.

Technology transfer to a new contract site often triggers regulatory submissions (e.g., site changes, comparability protocols, or new marketing authorization applications). How do you align your transfer execution timeline with regulatory strategy to avoid commercial supply gaps? How do you coordinate between your chemistry, manufacturing, and controls (CMC) regulatory team and the operations team at the contract organization?

Avoiding regulatory delays begins long before a submission is prepared. Aligning technology transfer with regulatory strategy starts with a QbD mindset. From the outset, we focus on risk assessment and the quality target product profile because those elements define what matters most to product performance, patient safety, and regulatory readiness.

We establish that foundation by reviewing the available reports and data within the technology transfer package or by conducting a gap assessment when key information is missing. This helps identify the critical components needed to support a robust QbD framework and ensures the transfer strategy is aligned with ICH guidelines and future regulatory submissions.

Strong coordination between CMC regulatory and operations teams is also essential. Internally, it ensures that technical decisions are made with regulatory commitments in mind. Externally, clear communication with the sponsor helps align on clinical milestones, submission timelines, supply needs, and the overall transfer objective.

At Lonza Capsugel, our regulatory team is integrated into the process, so all details are captured early, and the execution plan supports both technical transfer and regulatory strategy. Ultimately, avoiding gaps in regulatory submissions and commercial supply depends on strong communication between sponsors and CDMOs where there is a common understanding of the goals, timing, risks, and decision points before transfer execution begins.

Jamie Evans is a manager of analytical method development and validation at Lonza Capsugel. He brings more than 20 years of experience in the pharmaceutical industry, including more than 15 years in the CDMO space, with expertise in analytical validation for oral solid dosage forms and inhalation products. In his role, he supports customers throughout the tech transfer process at every stage of the product lifecycle.

Joe Cobb, CPIP, is a manager of formulations at Lonza Capsugel. He brings more than 30 years of experience in the pharmaceutical industry, including more than 25 years in the CDMO space. His expertise is in drug product design and development. At Lonza Capsugel, he specializes in formulation development, helping customers scaleup and navigate tech transfer at any stage of the product lifecycle.

Successful sponsor–CDMO technology transfer hinges on early risk assessment and gap analysis to surface missing data, define CQAs/CPPs, and implement QbD control strategies anchored by a quality target product profile. Process-knowledge gaps can be managed with change control and tools such as compaction simulation to predict compression performance using limited material. Analytical method transfer benefits from structured method gap assessments, pre-transfer evaluations, and optimization before formal protocols. Governance via project managers, escalation paths, and joint steering committees aligns CMC regulatory and operations plans to prevent submission delays and supply gaps.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.

Structuring Tech Transfer for Optimized Collaboration

Tim Stroud is Solutions Consultant Team Leader at Cenevo. He is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo, he worked as a scientist and lab automation specialist in the pharmaceutical industry at Pfizer and AstraZeneca. He leads Cenevo's team of solutions consultants, who deliver expert support to the sales teams in providing laboratory automation and software solutions to our clients in the academic, biotech, pharma, hospital, and agriscience sectors. www.cenevo.com

Pharmaceutical research team collaborating on drug development project. Experts in safety gear combining chemical testing with digital analysis in science lab. | Image Credit: ©ultramansk -stock.adobe.com

While scientific excellence within contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) is crucial, it’s now a commodity.

Competition is now operational. Margins are increasingly tied to efficiency; manual steps and disconnected systems directly impact cost and delivery.

CROs must deliver results faster at the highest levels of quality, accuracy, and repeatability at the lowest possible operating costs, all while elevating the client experience. CROs need fully predictable processes, moving samples through the lab efficiently and delivering data quickly. The CROs that can scale volume while simultaneously increasing speed without compromising quality are the ones that stand out.

Clients want to be secure in the knowledge that timelines will be met, with consistent outcomes, and full transparency and reporting. Clients want to understand what's happening with their samples and studies without having to chase the CRO for updates.

Long-term CRO success requires a focus on strengthening the following three operational aspects and building an organization that is fast, reliable, and trusted:

Efficiency and automation, which encompasses speed and scale. It’s about how quickly the CRO can move samples, execute workflows, and deliver results without increasing risk. Manual steps, disparate spreadsheets, and workarounds work at low volumes, but they quickly become bottlenecks as demand grows.

Data integrity and compliance must be a given. Clients and regulators primarily care about whether data are complete, accurate, traceable, and trustworthy, with integrity and authenticity.

This translates into standardized workflows, structured data captured at the source, and built-in readiness for audits and inspections.

Client experience has become a key differentiator. Clients are demanding more real-time visibility into what is happening. The CRO needs to proactively communicate with the client, keeping them abreast of all activities. It should not fall to the client to request status updates.

The catalyst driving lab digitization is simple: the CRO has outgrown spreadsheets and homegrown systems, and execution is difficult to manage. Furthermore, the dependency on manual operations has increased risks in compliance, auditability, traceability, and repeatability of experimentation.

The larger the CRO, the more manual processes and workflows cause significant bottlenecks and errors. Every time a sample comes in, is stored, moved, or processed, it needs to be tracked. The process needs to work just as well for 10,000 samples as for 10.

The key is going from survival mode operations to operations built to scale. In survival mode, samples are tracked by hand, inventory systems work fine until volume increases, and information is passed around in different files and emails. The result is reactive work.

Automation reduces the effort per sample. An organization operating at scale has standardized, automated workflows with no compromise in data quality, so the system can handle volume spikes. Their technologies are designed for growth; systems are connected end-to-end; and teams have real-time visibility into what is happening.

Strengthening Data Integrity and Compliance

As a CRO grows, data becomes more complex, with ever-increasing volumes. More studies are done; results need to be communicated to more clients; and all activities must comply with the latest regulatory requirements.

The adoption and application of FAIR principles: findable, accessible, interoperable, and reusable, can add value to CROs in the management of their clients’ data.

 If data are not structured properly from the beginning, management is a major challenge, especially if it’s siloed among hardware and software. With the volume of data generated by individual AI tools, data management becomes an even greater bottleneck. Properly managed data integrity results in standardized experimental design and protocols with structured, machine-readable results.

Once data management is out of the way, end-to-end sample traceability must be addressed. CROs need to know exactly where every sample has been, what has been done to it, and by whom. Barcoded samples combined with a comprehensive sample management system can be used to ensure this happens.

Everything needs to support built-in regulatory readiness. Instead of scrambling for audits or inspections, compliance is a natural outcome of well-designed workflows and connected systems.

Driving the Client Experience Toward Excellence

A strong client experience is a competitive advantage. When the CRO delivers clients visibility, transparency, and predictable delivery, client confidence increases significantly. Creating the infrastructure to be able to fulfill those requirements takes a measured approach.

In many CROs, this is how it works today: requests come in by email, phone, or chat. They ask:

Clients don't just want results; they want confidence in how those results were generated, stored, and reused. If systems don't talk to each other, information is scattered. No single place connects customers and the lab through the entire process. Every step becomes a bottleneck in the communications process. Clients must constantly ask for updates as each team is handling a different aspect of the project, and no one can give them the big picture. All this creates extra work that adds no scientific value but does significantly add time and expense.

The goal is to create a seamless, transparent partnership with clients. Instead of tens of messages back and forth and the time spent tracking everything from both sides, the ideal is a single two-way communications channel, with secure, segregated access providing real-time visibility into sample status, inventory availability, and more.

Scientific capability is no longer differentiating for CROs/CDMOs; operational excellence is. Competitive advantage now depends on digitized, connected workflows that increase throughput, reduce manual handoffs, and maintain quality while lowering cost. Scalable automation enables predictable sample movement and faster data delivery. Data integrity requires structured capture at source, FAIR-aligned management, end-to-end traceability (e.g., barcoding), and audit-ready compliance with 21 CFR Part 11 and EU Annex 11. Connectivity across automation, orchestration, data, and AI unlocks scale.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.