Rewriting the Rules of DMSO

In an industry where every molecule matters, gChem is raising the bar on excipient quality, reliability, and regulatory alignment. Formerly known as Gaylord Chemical, the company’s rebrand signals more than a name change—it marks a renewed focus on pharmaceutical innovation, with DMSO at the center of its strategy. In this exclusive Q&A, Rishi Pimentel, Global Business Development Director for Life Sciences at gChem, unpacks the thinking behind the rebrand, the science behind their flagship product Procipient®, and the company’s vision for enabling next-generation drug delivery.

As biologics, ADCs, and cell therapies move from pipeline to patient, the demands on excipients have never been higher. gChem’s Procipient—manufactured under ICH Q7 GMP and backed by global regulatory filings—aims to fill critical gaps in solubility, stability, and auditability. In this conversation, Rishi dives into how high-purity DMSO is shaping advanced formulations, reducing regulatory friction, and accelerating pharma timelines—all while staying true to gChem’s “chemistry with a conscience” mission.

Contract Pharma: Could you introduce gChem—its history, core mission, and why the rebrand from Gaylord Chemical matters today?

Rishi Pimental: gChem is the new face of what was formerly known as Gaylord Chemical Company, which is a brand with over 60 years of excellence in sulfur-based chemistry. The rebrand reflects more than a name change. This is our signal to the pharmaceutical world that we’re doubling down on our commitment to innovation, quality, and sustainability in drug delivery.

At gChem, our mission is to be the champion of DMSO for the benefit of our partners, the industry and the world at large. We support formulation scientists as they tackle the industry’s most complex dosage forms. Our goal is simple: to deliver high-integrity excipients and solvents—backed by the regulatory rigor, quality standards, and supply-chain reliability that today’s drug developers require.

Practically, the rebrand is about clarity for customers: if you work in biologics, cell therapy, ADCs or parenteral manufacturing, you want partners who are focused on those markets. gChem’s evolution reflects that focus.

CP: Procipient is widely cited as the only GMP-manufactured DMSO suitable for parenteral use and other complex modalities—can you explain its key quality and regulatory differentiators?

Rishi: Procipient (Dimethyl Sulfoxide USP, Ph. Eur.) is the only DMSO globally that is manufactured under full ICH Q7 cGMP conditions, which is a major differentiator for pharmaceutical developers.

What makes it stand out is its validated impurity profile. Specifically, we control residual dimethyl sulfide and acid content, along with tight impurity, water and endotoxin specifications and other degradation-related impurities to levels far below pharmacopeial DMSO. Those elements matter because DMSO is not just a solvent in these contexts, it becomes a process input for highly sensitive chemistries and sometimes a component of parenteral processes.

Our quality systems have full batch traceability, QP-reviewed dossiers, and Type II DMFs with the US FDA, a CEP with EDQM and a Type II DMF with Health Canada. All of this means that whether you’re developing, from a 505(b)(2) parenteral product or a novel topical formulation, you’re using a solvent that’s audit-ready and designed for patient-facing products and not just a repurposed industrial chemical. The differentiators are practical and audit-facing: lot-to-lot consistency and endotoxin test data, full Certificates of Analysis, full traceability, and regulatory support documentation that help formulators reference a qualified excipient in IND/BLA/MAA filings.

In short, Procipient shifts DMSO from being “lab reagent” to being a documented, auditable pharmaceutical excipient.

CP: How is Procipient used in antibody-drug conjugation today? Describe typical use cases and how purity and quality play a role?

Rishi: In antibody-drug conjugate (ADC) manufacturing, DMSO’s core role is solubilizing and stabilizing hydrophobic payloads and linker-payload intermediates. Procipient enhances this function by enabling efficient solubilization and providing stability for delicate intermediates, where purity is essential for maintaining consistent DAR and controlling aggregation.

Typical use cases include preparing concentrated payload stocks, dissolving linker-payload constructs for addition to antibody reaction mixtures, carrying payloads through formulation and fill steps, and in some cases as a solvent for analytical method development or shipping small-scale intermediates.

Purity and quality directly affect three measurable outcomes, which include, but are not limited to payload recovery (loss due to degradation or adsorption), drug to antibody ratio (DAR) reproducibility (where these impurities can create side reactions or hydrolysis), and aggregate formation (in which trace contaminants can promote protein unfolding). Using our Procipient, which is low-impurity DMSO, minimizes those failure modes and reduces downstream analytical and regulatory friction.

CP: In ADC manufacturing, how does DMSO function to improve process, delivery, regulatory approvals, and patient compliance? Any safety or formulation considerations?

Rishi: What we are talking about here are process and delivery of the product, regulatory landscape, patient compliance and safety. For process and delivery, I see DMSO enabling high-concentration payloads that allow efficient dosing and accurate stoichiometry during conjugation, improving reaction efficiency and consistency of DAR. It also reduces the need for complex co-solvent systems that can complicate scale-up. Efficiency is the key driver with Procipient.

When we are looking at regulatory approvals, and the excipient is parenteral-grade and supported by batch documentation, regulatory reviewers have less cause for excipient-related queries, accelerating CMC review and reducing the back-and-forth that stalls filing timelines. Procipient can help to shorten the approval cycles.

Another key driver is patient compliance. With better process control you see improved yields that are more consistent for product quality, enhancing safety and efficacy profiles for end users. DMSO is not inert clinically! Using Procipient first, mitigates many of these formulation risks.

CP: What recent innovations or application trends are you seeing in ADC manufacturing that involve DMSO? Are new modalities emerging?

Rishi: We’re seeing three specific practical trends.

First, more ADC payloads that are extremely hydrophobic or chemically delicate, which increases reliance on high-quality aprotic solvents for dissolution and storage

Second, a move to have earlier adoption of GMP-grade excipients so the same material is used from GLP through commercial scale to avoid requalification

And finally, I believe we are seeing broader cross-application use. For example, teams developing polymer-drug conjugates or certain targeted payload delivery platforms reusing ADC-grade chemistries.

On the modality front, Procipient’s role in cryopreservation and cell therapy logistics continues to draw attention where the need exists to meet parenteral expectations and is attractive where process continuity matters across modalities.

CP: Could you share any recent highlights or news at gChem—such as the rebranding, regulatory filings, or partnerships—that are especially relevant to pharma formulators?

Rishi: The rebranding to gChem is more than cosmetic, it came alongside our launch of new manufacturing capabilities in North America and enhancements to our quality systems. We’ve recently submitted updates to our US and EU Drug Master Files for Procipient, reflecting its broader use in biologics and injectables.

We’ve also increased our engagement with CDMOs and CROs and formulation teams to deliver sample programs, stability data and dossier packs to support filings. For product details and contact points, the product pages and technical resources on our website: www.gchemglobal.com are the best starting place.

CP: How does gChem support pharma partners beyond supplying DMSO—e.g. technical services, formulation support, regulatory documentation or CDMO collaborations?

Rishi: I really like this question. Our highly experienced life science team has deep and well-trenched background in topical, injectable, and solubility-limited formulation. We view ourselves not just as a supplier, but as a formulation partner. We position Procipient as a partnership offering, not a commodity.

This means that we can offer hands-on technical engagement for solubility and compatibility testing; supply of sample material with CoAs and stability data; preparation of regulatory support packs to help customers reference the excipient in IND/BLA/MAA submissions; and active collaboration with CDMOs and CROs to support tech transfer and scale-up. That’s a big value-add we offer, and it saves partners months in the process.

These services reduce the integration burden on a developer’s CMC team and expedite qualification.

CP: In today’s pharma ecosystem, what gaps or challenges does Procipient help to address, particularly in complex dosage forms and ADC manufacturing?

Rishi: One of the biggest gaps is the lack of excipients that are both high-performing and regulatory-friendly. Solvents like NMP, DMF, or even ethanol often come with toxicity or stability tradeoffs.

Procipient is unique because it combines powerful solubilization and penetration enhancement with a clean safety and compliance profile. These are critical capabilities that Procipient can impart in a world shifting toward patient-centric and combination therapies. Procipient addresses three persistent gaps:

• Excipient auditability where many small molecules still rely on lab-grade DMSO and must requalify materials at scale;
• Process variability that is impurity-driven variability in DAR and aggregates; and
• Regulatory friction where too much time is spent justifying excipient choice instead of focusing on API and clinical endpoints.

By providing a documented GMP-manufactured DMSO like Procipient, we are supporting our partners in reducing their failures and free up resources across process, quality and regulatory teams.

CP: How does gChem’s sustainability and quality philosophy, “chemistry with a conscience”, influence how you manufacture and deliver Procipient?

Rishi: Sustainability and safety go hand in hand for us. Our DMSO is manufactured in North America using a closed-loop sulfur recovery process that minimizes waste and environmental exposure. Every batch is tested not just for what’s in it but for what’s not in it. We believe quality doesn’t stop at compliance. Controlling impurities and designing efficient processes reduces waste, rework, and the carbon footprint of any pharmaceutical program.

CP: Looking ahead, what role does gChem see for itself in the evolution of drug delivery—especially as new excipients, polymers, or delivery platforms emerge?

Rishi: At gChem, we see ourselves as platform enablers. Enabling innovation. Enabling more efficient manufacturing processes. Enabling greener chemistries. Enabling better patient outcomes. The list goes on, especially when we are talking about Procipient.

What I mean by this is that that we see how our Procipient can impact solubility-challenged or permeability-limited drugs. Whether in nano-emulsions or in-situ forming implants, microneedle delivery, or even cell and gene therapies, the need for safe and effective solvents will only grow. As new biologics and hybrid modalities come to market, developers need excipients (and not expensive processing or IP heavy technologies) that are not just GRAS, but performance validated and regulator ready. That’s the niche Procipient fills, and we plan to expand our portfolio in line with that mission.

We’re not just making DMSO. We are reimagining what DMSO can do. Our Procipient is “Built for Pharma. Backed by Science. Proven in Practice.”

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