"Lubrizol will focus on its commercial manufacturing, as we have the capabilities to take development projects into GMP production."
Can you provide an overview of Lubrizol’s CDMO Division?
Lubrizol is a full-service CDMO that grew out of the drug delivery space, which continues to be our core competence. We offer all supporting services including analytical method development and validation, physicochemical characterization, and manufacturing of drug products for R&D through cGMP. Our versatility allows us to handle highly potent compounds along with DEA controlled drugs from schedules 1 through 5. Lubrizol covers virtually every route of administration with 60% of our programs being parenteral, 25% ophthalmic, and the rest divided between topical, mucosal and oral.
With respect to the types of programs the company works on, Lubrizol is fairly boutique. Around 35% of our programs are new chemical entities under NDAs, 35% 505(b)(2) applications (which makes sense given our expertise in drug delivery), and the rest is split between ANDAs and OTCs. Our clients range from venture-base startups to the largest pharma, generic, biotech companies and everything in between. As a result, we work with a variety of molecules – around 85% being small molecules and the rest biologics.
Which services did you see the most demand for in 2021?
Lubrizol has been working on many ophthalmic projects in both the topical and intravitreal space as well as proprietary PLGA microparticles for intravitreal administration. We have a very robust drug-eluting device group which is designing and manufacturing intraocular implants, something we recently signed a program to do the commercial manufacturing for. We are also seeing a lot of interesting dosage forms, including quite a bit of nasal delivery and nanomilling, which remains a key option for formulating water-insoluble compounds.
Can you elaborate on the benefits of nanomilling and what Lubrizol’s services in this space look like?
The basic idea behind nanomilling is to increase the surface area-to-weight ratio (i.e., specific surface area) of an API by reducing the particle size well below 1,000 nm. This conversion of drug particles into nanocrystals allows for greater interaction with water, thus increasing the dissolution rate. Nanomilling has proven to be a particularly efficient, reproducible, and scalable process. The original intellectual property covered APIs with solubilities up to 10 mg/mL. In practice, the more insoluble the API, the better the process may work; however, this needs to be empirically evaluated. This delivery technology is an appealing first-line approach to solubilization concerns and is suitable for oral, injectable, topical, and inhalable applications.
Lubrizol has a Nanomilling Feasibility Program that allows clients to quickly and inexpensively identify whether the technology would work for their unique molecule and application, taking into consideration potency/dose, concentration, and route of administration.
What facilities does Lubrizol have to support these activities?
Lubrizol has a commercial manufacturing site built for lower volume, higher value products. The facility offers 3,000 sq. ft. of flexible, purpose-built cleanroom suite space and allows for a wide range of capabilities built around complex drug product development and GMP manufacturing. This is supported by in-house analytical services, physicochemical characterization, and ICH-compliant stability programs. Our capabilities also include flexible filling for biologic and small molecule drug products for vials and ophthalmic bottles, and our 120 sq. ft. commercial lyophilizer offers clean-in-place capability allowing for aseptic processing. In our cleanrooms supporting the manufacture of clinical trial materials, we also offer filling of cartridges and syringes.
What are the biggest challenges currently hindering the US life sciences environment?
Supply chain disruptions on manufacturing components have been horrifying. In some cases, the unpredictable availability of single use systems, filters, raw materials, and other products often taken for granted has led to dramatically longer lead times.
Conversely, where are do you see the most growth?
Individualized medicine is a fascinating area for innovation, and we have seen a strong push towards tailoring treatments for specific populations, keeping in mind associated costs. Drug device combination products such as targeted delivery and wearable devices are increasingly popular, and we can expect continued interest here.
What is Lubrizol’s vision for its CDMO division over the next few years?
Lubrizol will focus on its commercial manufacturing, as we have the capabilities to take development projects into GMP production. We believe the demand for sterile and aseptic manufacturing services in particular will continue to increase, given the growth in biologics and their integration into drug/device combination products. Additionally as many nano- and microparticulate-based formulations are not amenable to terminal sterilization, we see aseptic nanomilling as a great option because it supports every sterile route of administration.