With the rise of targeted therapies, complex biologics, and ultra-potent small molecules, the role of pharmaceutical development has evolved far beyond its traditional scope. Today, it demands greater integration into the drug development pathway, condensed timelines, and technical agility across drug delivery formats and therapeutic modalities.
In this Executive Q&A, Drug Development and Delivery speaks with Anshul Gupte Ph.D. RAC Drugs, Vice President of Pharmaceutical Development at PCI Pharma Services, about phase-appropriate development, technical hurdles in pharmaceutical sciences, building agile teams, and what sponsors should prioritize when planning their strategy for novel therapies.
Tap into expert knowledge: Explore the key questions and in-depth insights from Dr. Anshul Gupte. below.
Pharmaceutical development is not a one-time event. It’s a continuous, evolving function that plays a critical role across the full lifecycle of a drug product, from selecting the appropriate molecule post-discovery through “druggability” studies to extending the life cycle of the drug product through reformulation. The scope of pharmaceutical development begins with defining Target Product Profile (TPP) and ensuring that the Critical Quality Attributes (CQA) e. g. identity, strength, purity and potency are built into the final drug product.
Pharmaceutical development in today’s drug development landscape involves evaluating and establishing a drug product that is stable and manufacturable across multiple drug product presentations throughout the clinical, commercialization life cycle. It’s an iterative process, interacting upstream with drug substance development and downstream with packaging development.
As the product progresses through clinical stages, the formulation evolves. A powder-in-capsule or a liquid in a vial drug product may ultimately become a modified-release tablet or a prefilled syringe product. At each phase—early, mid, and late-stage—our work supports different goals: speed and flexibility in early development, robustness and scalability late stage, and long-term stability and reproducibility by the time we reach commercial.
Today’s development landscape is dominated by targeted therapies, which create a unique set of challenges. These include low bioavailability challenges due to the drug discovery paradigm, content uniformity challenges due the low doses required to achieve the desired pharmacological activity (as these are targeted modalities), and safe handling challenges for highly potent compounds.
Moreover, pharmaceutical development also encompasses packaging—understanding how the drug product interacts with its final container closure system, whether it’s a blister pack, bottle, vial, syringe, or cartridge. So it’s not just about formulation and process—it’s also about ensuring compatibility and stability through to the final packaging configuration.
Scientifically, pharmaceutical development should be conducted following Quality by Design (QbD) principles as it provides a systematic approach to development. QbD works through predefined objectives, emphasizing product and process understanding and control based on sound science and quality risk management.
We always begin with the end in sight, which translates to what’s required in terms of desired final product quality, safety, purity and effectiveness. Defining these through the TPP should always be the first step. But TPP isn’t static—it becomes more focused as the development journey progresses. Initially, it’s broad and flexible, but by the time you're entering mid to late-phase trials, you're working within defined specification limits that reflect real-world use, regulatory expectations, and patient needs.
Strategically, I believe in building a flexible, stepwise, phase-appropriate development plan—thinking several stages ahead, but always focusing on the immediate goals of the current phase, e.g. start with a simple neat API in capsule formulation that has sufficient stability for the duration of a first-in-human study, followed by development of robust formulation for later phase clinical studies.
A phase-appropriate plan should emphasize defining clear inputs and outputs for every stage. What data do we need to generate at this point? What knowledge must we carry forward to the next phase? That operational discipline ensures each phase builds intelligently on the previous.
Operationally, communication is a cornerstone. We work closely with our clients’ clinical and CMC teams to align what they want with what is scientifically and operationally feasible. Our job as a CDMO is to interpret the information provided by the client into a viable formulation that’s scalable and patient-friendly—without locking ourselves into a rigid path that won’t adapt well as requirements evolve.
We think of phase-appropriate development simply in terms of translating the pre-clinical and clinical journey of the drug product (tox batches, Phase I/II/III) to stage gates for our pharmaceutical development process. Phase-appropriate development is about defining your goals and technical rigor based on where you are in the drug development lifecycle.
In early development, the goal is to get to the clinic fast. Flexibility during development to cover a wide dose range and adapt the formulation and process with non-clinical or clinical data is crucial. As we move through the clinical phases, we begin identifying Critical Material Attributes (CMA), CQAs, Critical Process Parameters (CPP) and understanding the interplay between CMAs, CPPs and CQAs. Evaluation of the above elements leads to optimal control strategy and specifications for the DS, ingredients, and the process steps.
Drug substance is often being scaled from lab to pilot to commercial scale concurrently as the drug product is being developed. That means communication between drug product and drug substance teams—or CDMOs—is critical. You can't develop a robust formulation without understanding how the API might change in morphology, particle size, or impurity profile as it scales. For targeted therapies in particular, the margin for error is minimal.
Our facility in Tredegar, Wales offers the full range of Oral Solid Dose (OSD) and Liquid formulation and analytical development, supported by on-site clinical and commercial manufacturing and packaging. The site specializes in handling High Potent APIs (HPAPIs). We support toxicological batches, First in Human (FIH), early-phase and late-phase clinical development.
The typical OSD processes supported include direct compression, roller compaction, wet granulation, milling, compression, encapsulation, and film coating. We support variety of dosage forms e.g. tablets, capsules, powders, solutions, and suspensions for Immediate Release (IR), Paediatric dosing, Orally Disintegrating Tablets (ODT), modified-release (MR) products, and others.
Our facilities in Bedford, NH and León, Spain offer sterile formulation and analytical development, supported by on-site clinical and commercial Sterile Fill Finish (SFF). Bedford is a recognized leader in lyophilization development, with over 700 lyophilization cycles successfully developed, optimized and transferred in manufacturing. Our León site also has unique capabilities in microparticles, nano-emulsions, and ophthalmic development.
PCI is investing approximately $10M to further expand our development offering. The investment will ensure that, in addition to non-potent compounds, we will be able to handle HPAPIs, small molecules, biologics and a range of conjugates such as ADCs, PROTACs, and others. Our investment is focused on three fundamental pillars: the right facility, appropriate equipment, and technically competent talent. Through these, we will establish Pharmaceutical Development Centres of Excellence (CoE) at our Bedford and León facilities. These CoEs are expected to be operational in early 2026.
Through our development CoEs, we will be able to support a wide range of formulations including liquids, emulsions, lyophilized products, ophthalmics and diagnostic reagents, as well as an extensive variety of drug product presentations – vials, syringes, cartridges, bottles and IV bags. We will also provide technical partnership and solutions for complex modalities and formulations, such as long acting injectables (LAI) and high viscosity injectables for subcutaneous or intramuscular routes.
PCI’s three segments – Development and Manufacturing (D&M), Clinical Trial Services and Commercial Technology Services – provide integrated services to our clients throughout their supply chain.
Each of our three development sites (Tredegar, Wales; Bedford, NH; and Leon, Spain) have co-located formulation and analytical teams to ensure speed, coordination, and agility. We have identified areas that we need to supplement our knowledge and capabilities with agile and competent partners. These partners allow us to offer specialized bioavailability/solubility enhancement solutions or specialized analytical testing, ensuring that every element of development – from development to commercial packaging – is aligned. We work closely with our clinical manufacturing and packaging teams on site and throughout our global network, resulting in industry-leading ur packaging integration. With high-potency and sterile packaging facilities in the UK (Hay, Bridgend) and the US (Philadelphia, Rockford), PCI brings packaging into development discussions early to prevent formulation-packaging incompatibilities.
This is supported by global clinical and commercial distribution capabilities, enabling us to truly offer a "molecule-to-market" solution under one network.
The absence of HPAPI handling capabilities in both oral and sterile development has been a key barrier to offering comprehensive development solutions for targeted modalities such as ADCs, PROTACs, and others.
Today, some of the most significant technical challenges in formulation development include poor solubility and bioavailability, as well as stability concerns for oral solid dose (OSD) formulations. In sterile development, challenges include poor solubility, the need for high-concentration formulations, and stability issues.
We train our scientists to be accountable stewards of the drug product. When a problem arises – say, a formulation or analytical issue or unexpected issue during batch manufacture or release – we expect our teams to study the data and propose suitable hypotheses. We bring those to the client immediately, rather than working in a silo to find the “perfect” answer.
We work collaboratively, engaging clients in the troubleshooting process from the beginning. That’s how we save time and resources—by solving problems as one team, rather than wasting cycles chasing the wrong hypothesis.
We also emphasize managing API with care. Especially during early phase of development, the material is precious. So, we train our teams to plan experiments meticulously, use only what’s necessary, and always get client buy-in for optional studies.
Start early. Engage a drug development partner who offers integrated services, not just formulation and analytical development but also manufacturing, and packaging. Nobody can do everything, but the simpler your supply chain, the fewer risks you face. Vertically integrated drug substance and drug product CDMOs present a great solution, but understanding their capabilities is crucial as they might be fully integrated, but have expertise only in certain aspects of the drug development process.
Make sure your partner is flexible, scientifically robust, and honest about what they can and cannot do. And find someone who’s willing to find the best solution to your molecule rather than pushing their solution to fit your molecule. This could mean engaging with external expertise where needed. We’ve done this ourselves, partnering with best-in-class solubility and specialized testing vendors to supplement our core strengths.
Above all, treat your CDMO as a strategic collaborator. Bring them in early and share your plans. Let them help you build a roadmap for your product. That’s how you accelerate development and avoid costly missteps.