Drug Product Formulation and Manufacturing Services (CDMO)

Altasciences is ready to support your program with manufacturing services and analytical testing across formulation development, GMP manufacturing, analytical testing, release testing, stability storage, packaging, and clinical supply. Our teams work with small molecules, controlled substances, potent compounds, and complex formulation requirements, including solubility, bioavailability, and specialized dosage form challenges.

From early formulation work through clinical supply and commercial-scale manufacturing, we bring formulation, manufacturing, analytical testing, quality, and release planning into one CDMO environment.

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Proven CDMO and Analytical Testing Expertise

Our experts bring decades of CDMO experience to your product formulation and pharmaceutical manufacturing.

Your drug product will be formulated and manufactured in a CDMO infrastructure that includes an FDA-inspected facility, R&D formulation laboratories, analytical laboratories, GMP manufacturing suites, a cGMP warehouse, and specialized areas for potent compounds and controlled substances.

Altasciences is your comprehensive early drug development outsourcing solution. From discovery to preclinical, to clinical proof of concept, and beyond. By having a single partner with one program manager overseeing all of your projects, your CDMO and clinical research teams can work in tandem to accelerate your progress to proof of concept and proactively resolve challenges. The advantage is reduced risk and significant savings in both overall time and financial investment. We offer pharmaceutical contract manufacturing, development, and analytical services, including formulation development, phase one through commercial manufacturing, and ICH stability storage and testing. So we have our our schedules one through five, here at Altasciences, so we're able to handle controlled substances for our clients. That schedules one through five is in analytical and manufacturing. Another unique offering that we offer here is the grade c room. It's a dual purpose room. So first, it is capable of handling potent products for our clients, which is becoming increasingly more and more desirable. And the second one is a higher classification of a room. So products that need to be terminally sterilized for injectables, we're capable of handling those here at Altasciences. We provide analytical method development, qualification, and validation, as well as finished product and release testing. Our experts work with cutting edge and scalable equipment for quicker development time and method validation. Altasciences has tested or manufactured a wide variety of small molecule dosage forms. Our highly skilled team is extremely flexible and focused on releasing quality batches successfully the first time. Quality, has to be number one in any CDMO pharmaceutical company. Quality has to come first. But another thing that we're very good at here is being able to move quickly for our clients, being able to change on a dime, being able to bring in new equipment for our clients, and being able to really help them through their process of getting them to the end product quicker than really anybody else and not sacrificing any quality while we do that. Our integrated adaptive GMP manufacturing experts work closely with our clinical facilities to manufacture and deliver clinical grade material with speed and ease. One of the unique advantages of Altusciences is that there's no handoff between a CDMO organization and a clinical organization. We're integrated. So a drug sponsor has one less vendor to manage by coming to Altasciences. And as such, the CDMO organization is gonna make sure that we're going to meet that clinical timeline. Altasciences has a successful history of working with regulatory agencies. Our facilities and equipment are designed, built, and fully qualified to meet or exceed current regulations worldwide. Through collaboration and tailored solutions, we help you get better drugs to market faster. Here at Altasciences, our clients have always told us that they appreciate the quality of work that we produce and also the integrity of the people that are involved in working on their project. The most important thing that we do wanna drive home with our clients is developing that the trust that goes in with any project. This might be their product, but we work on it as a team, and that's a critical piece to the whole development program. Reliable, responsive, and quality focused, we are Altasciences.

Why do clients choose to partner with Altasciences?

In-house R&D and analytical testing to drive formulation success
Cost-effective, flexible optimization experience from small prototype batches to commercial scale
Segregated Grade C cleanrooms for potent compound handling
Environmental monitoring system
Specialized expertise in liquid-filled capsule manufacturing
Experience with techniques such as nanomilling and spray drying
Formulation, analytical testing, manufacturing, product release testing, ICH stability storage and testing, and packaging, all on one campus
Experience with APIs, highly potent APIs (HPAPIs), and specialized dosage form requirements

100+

YEARS OF COMBINED EXPERIENCE

99%

ON-TIME DELIVERY

DEA

LICENSE FOR SCHEDULE I-V

Explore Altasciences’ CDMO Services

We offer drug product formulation and manufacturing services spanning formulation development, GMP manufacturing, clinical supply, specialized handling, analytical testing, and batch release.

Formulation decisions influence your program’s solubility, bioavailability, process design, analytical method requirements, stability strategy, packaging, and the ability to manufacture clinical supplies on schedule. This is why we develop formulations with the broader development path in mind.

Our teams evaluate molecule characteristics, intended route of administration, study requirements, manufacturability, and testing needs before moving into production. This helps create a formulation strategy that can move beyond the bench and into GMP manufacturing.

Whether you require a single CDMO service or a fully integrated development and manufacturing program, our team provides flexible solutions tailored to your needs.

For additional information on our drug development and manufacturing services, consult the following resources:

Fact Sheet: Pharmaceutical Contract Manufacturing Fact Sheet
Webinar: Overcoming The Challenges of Manufacturing and Clinical Trials

Analytical Testing and Quality Assurance

Our analytical services move in tandem with formulation and manufacturing, from method development and validation to product release and stability testing. With advanced analytical procedures, we ensure the quality of your products and validation of your analytical methods, meeting not only your requirements, but also those of regulatory agencies worldwide.

Method Development, Qualification, and Validation

Method Development, Qualification, and Validation

We develop, qualify, and validate analytical methods designed around your product’s unique characteristics, dosage form, impurities, degradation pathways, and intended use. Our expertise supports product quality assessment, manufacturing consistency, and regulatory readiness through robust analytical data.

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Pharmaceutical Product Release Testing

Pharmaceutical Product Release Testing

We perform release testing to confirm your drug product’s quality, consistency, and readiness for clinical or commercial use.

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Excipients and Active Pharmaceutical Ingredients (APIs)

Excipients and Active Pharmaceutical Ingredients (APIs)

We provide all necessary United States Pharmacopeia/National Formulary (USP/NF) and European Pharmacopeia (EP) testing for materials received, with a rapid release from our analytical department.

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ICH Stability Storage and Testing

ICH Stability Storage and Testing

In an ICH-aligned environment, we conduct stability and storage testing to help determine how your drug product performs over time under ideal and defined storage conditions.

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Additional Drug Product Manufacturing and Packaging Capabilities

In addition to our formulation, manufacturing, and analytical capabilities, our solutions also include:

Receipt, storage, release, and distribution support
Phase I, II, and III clinical supply
Large/commercial-scale pharmaceutical supply
Primary and secondary packaging
Bottle and blister packaging
Clinical packaging
Packaging design

We can also support your unique project demands by reserving dedicated space and equipment.

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Integrated CRO and CDMO Services for Faster Drug Development

With fully integrated CRO and CDMO services—all centralized and managed right here at Altasciences—we can significantly accelerate your drug development timeline and seamlessly transition your program from one drug development phase to the next.

Formulation, Nonclinical, and Clinical Development in Tandem

Once we have formulated your drug product, our in-house nonclinical team will evaluate its safety profile. Concurrently with these safety assessments, we develop a reproducible and scalable manufacturing process, detailing the appropriate equipment and establishing relevant parameters.

Once safety testing is completed and before clinical trials begin, our regulatory team will compile your nonclinical data, clinical trial protocols, and information about the manufacturing process to be included in your Investigational New Drug (IND) application.

With the IND approved, we can begin your clinical trials. If the clinical results are positive, our experts will scale up and optimize the manufacturing process to prepare your drug product for commercialization.

Because we have a holistic view of your program, we can anticipate and resolve any situation that might impact your project, thus reducing complexities, mitigating risks, condensing timelines, and enabling cost savings.

Related Services and Development Capabilities

In addition to CDMO services, we offer complementary scientific, clinical, laboratory, regulatory, and operational capabilities, giving you the flexibility to partner with us for focused manufacturing or analytical services, or connecting them with a broader early-phase development program when needed.

Explore our integrated services:

The Altasciences Acceleration Platform

Formulation and manufacturing services for small molecule programs are available on its own or as part of the Acceleration Platform―Altasciences' integrated framework for compressing nonclinical-to-clinical development timelines through parallel execution, with the potential to reduce overall timelines by up to 40% and reach clinical proof-of-concept in as little as 18 months.

See how the Acceleration Platform works

Related Resources

Frequently Asked Questions About CDMO Services

When should I involve a CDMO in early development?

Sponsors should involve a CDMO before formulation, analytical methods development, manufacturing processes, and clinical supply timelines begin moving separately. Early CDMO input can help identify solubility, stability, manufacturability, product release testing, packaging, and storage requirements before they create problems later in development.

This is especially important when a program involves poor solubility, controlled substances, highly potent compounds, specialized dosage forms, or compressed clinical supply timelines.

How does formulation development affect clinical supply readiness?

Formulation development influences whether a drug product can be manufactured consistently, tested appropriately, packaged correctly, and released on time for clinical use. A formulation that works at the bench may still require process refinement, analytical method alignment, stability planning, and packaging evaluation before it can move into GMP manufacturing.

Connecting formulation development with manufacturing and analytical testing early helps sponsors avoid late-stage adjustments that can affect clinical supply timelines.

Can Altasciences help with poorly soluble compounds?

Yes. Altasciences offers formulation approaches for compounds with solubility or bioavailability challenges, including wet nanomilling, spray-dried dispersions, liquid-filled capsules, and other dosage form strategies.

The right approach depends on molecule characteristics, intended route of administration, target product profile, manufacturing requirements, and clinical study needs.

Can Altasciences handle controlled substances or HPAPIs?

Yes. Altasciences has capabilities for controlled substances and potent compounds, including DEA licensing for Schedule I-V controlled substances and dedicated handling capabilities for potent compounds and HPAPIs.

Programs involving these materials require additional planning around security, containment, documentation, cleaning, storage, personnel protection, and regulatory expectations. These requirements should be built into the CDMO strategy early.

How do analytical methods affect manufacturing and release timelines?

Analytical methods determine how product quality, potency, purity, impurities, dissolution, degradation, and stability will be evaluated. If methods are not ready when manufacturing is complete, release testing and clinical supply availability can be delayed.

For this reason, method development, qualification, validation, manufacturing, and stability planning should move together rather than being treated as separate workstreams.

What should I consider when moving from development batches to GMP manufacturing?

Sponsors should consider whether the formulation, process, equipment, batch size, analytical methods, packaging, and stability plan can carry forward into a GMP environment. Small development batches may answer early feasibility questions, but clinical supply requires controlled manufacturing workflows, documentation, quality review, and release testing.

A strong CDMO partner should help identify which development decisions need to be refined before GMP manufacturing begins.

Can Altasciences manufacture blinded or over-encapsulated clinical trial materials?

Yes. Altasciences provides over-encapsulation and blinded study material capabilities for clinical trial programs that require masking, comparator preparation, or specialized clinical supply presentation.

These projects often require careful planning around capsule size, product appearance, packaging, labeling, release testing, and clinical trial design requirements.

How does stability testing fit into CDMO planning?

Stability testing helps determine how a drug product performs under defined storage conditions over time. Stability data can influence formulation decisions, packaging selection, shelf life, storage conditions, clinical supply planning, and regulatory documentation.

Building stability planning into the CDMO strategy early lets sponsors understand product behavior before later development decisions depend on it.

Can Altasciences support both clinical supply and commercial-scale manufacturing?

Yes. Altasciences provides CDMO services for development, clinical supply, and commercial-scale manufacturing needs. The appropriate manufacturing strategy depends on batch size, dosage form, product requirements, quality expectations, and development stage.

For many sponsors, the key is ensuring that early formulation and process decisions can reasonably carry forward as the program advances.

How can CDMO services connect with clinical development?

CDMO work affects clinical development through drug product availability, release testing timelines, packaging, labeling, stability data, storage conditions, and shipment planning. If these activities are not aligned with study timelines, clinical start-up can be affected.

Altasciences can connect CDMO activities with clinical, regulatory, bioanalytical, and program planning so manufacturing and testing decisions reflect the needs of the study.