Formulation and process. For injectable therapeutics.
Supporting liquid & lyophilizate presentations from preclinical through commercial and lifecycle management.
Formulation and process development, 16 years in numbers
- Since 2010
- 8+ years average scientist tenure
- Martinsried, Munich
- 2 to 4 weeks from scope to project start
- 9/10 average satisfaction rating
formulation, process, and CMC projects completed
formulations advanced to GMP manufacturing
short- and long-term stability runs completed
lyophilization development programs
The situations you face today
You come to us with a challenge, not a service name. Here are six of the most common.
Formulation and process development, manufacturability first.
We develop formulations and processes that stay stable and transfer to your manufacturer. Each new development stage asks something new of both.
Manufacturable.
We mock up your manufacturer’s process at pilot scale, so the formulation transfers with its critical process parameters and ranges defined.
Fast and flexible.
Results are reported within 5 days, so each experiment can shape the next one in your plan.
Scientists first.
You talk directly to the scientists who run your experiments, with one project manager and one lead scientist for each program.
Which molecule are you formulating?
We formulate antibodies, ADCs, peptides, small molecules, viral vectors, and liposomes for injection, from candidate selection to transfer.
Three parts, one stable product.
Antibody, linker, and payload each degrade differently. We formulate the conjugate and its intermediates, including lyophilization of linker-payloads from organic solvents.
Liquid or lyophilized, at high concentration.
We formulate monoclonal and bispecific antibodies as liquids or lyophilizates, including high-concentration formulations for subcutaneous delivery.
From bench to pilot batch.
We offer formulation, compounding process development, and aseptic, non-GMP toxicology batches for cytotoxic and highly potent compounds, under containment up to OEB5.
Keep your peptide in solution.
Peptides can aggregate, form fibrils, or adsorb to glass. We develop the formulation that keeps your peptide in solution and stable.
Two proteins, one formulation.
Fc-fusion proteins carry the stability risks of both parts. We develop the formulation that suits the whole molecule.
Keep the capsid intact.
Freeze-thaw, shear, and surface adsorption all stress viral vectors. We formulate adenovirus, AAV, lentivirus, and virus-like particles in a dedicated BSL-2 laboratory.
Stable vesicles, stable payload.
Size, lamellarity, and encapsulation have to hold through storage and lyophilization. We develop the formulation and the freeze-drying cycle that keep them.
How do we develop your
formulation and process?
Six service areas, each run as fixed-price work packages with defined go/no-go points, reports, and hand-offs.
Liquid, frozen, and lyophilized formulations, developed with design of experiments under a quality-by-design approach.
Freeze-drying cycles designed, optimized, and troubleshot, with pilot runs set to the limits of your manufacturer’s freeze-dryer.
General process development
Scale-up, manufacturability assessment, and process mock-ups, completed before transfer to your manufacturer.
Chromatography, mass spectrometry, light scattering, and particle analysis, with methods set up alongside your formulation.
Accelerated, real-time, forced degradation, and in-use studies, following ICH stability guidelines.
Aseptic, non-GMP preclinical batches for toxicology and stability studies, including ADCs and cytotoxics.
PJP’s flexibility, agility and speed are more valuable than integrated capabilities.
Top 5 Pharma · on ADCs and large molecules
Questions we know you have, and actually helpful answers
How quickly can you start a project?
Usually 2 to 4 weeks after we agree on the scope. Once your material arrives, the scientists who planned the work start in the laboratory.
Do you manufacture GMP clinical supply?
We make aseptic, non-GMP preclinical batches, then transfer the formulation, process, and critical process parameters to the GMP manufacturer you choose.
Which development stages can you support for our molecule?
From candidate selection to late-phase and lifecycle work. Of 178 formulations advanced to GMP manufacturing, 98 are in clinical trials and 80 have reached market approval.
Which containment and biosafety levels do your laboratories offer?
Cytotoxic containment up to OEB5 (SafeBridge category 4), BSL-1 and BSL-2 laboratories, and physically separated laboratories for biologics, cytotoxics, and live viral vaccines.
Where are your laboratories and team located?
In Martinsried, Munich’s biotech cluster, with about 850 m² of development laboratory space at Fraunhoferstrasse 22. Business development also works from Boston, Massachusetts.
Didn’t find your question? Conversations and quotes are always free.
Let's talk about your program.
Our calls get technical quickly. If another partner fits better, we’ll tell you.