Service Overivew

LakePharma's DNA Studio Group offers essentially all recombinant DNA services. These include gene synthesis, PCR cloning, mutagenesis, plasmid vector design and construction, and DNA sequencing and analysis. Codon optimization and gene synthesis are performed in-house, and customized design software and process automation facilitates throughput. Plasmid purification is offered at multiple scales. The process is highly streamlined with rapid turnaround.

For a faster response from our DNA Studio Group, please email inquiries@lakepharma.com.

Utilizing multiple technology platforms, LakePharma offers a range of services and solutions to identify novel monoclonal antibodies and determine their sequences. 

1. Hybridoma technology: comprehensive, customized hybridoma campaigns for therapeutic antibody discovery.

2. Naïve synthetic, or immune antibody libraries: LakePharma has licensed multiple phage (XOMA, Moradec, etc.) and yeast antibody display libraries, and employs them for unparalleled de novo antibody discovery to be used as therapeutics or diagnostics (reagents). 

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details.

LakePharma offers a broad range of antibody engineering and characterization assays for lead identification and optimization to be used as diagnostic reagents or therapeutics.

We routinely perform antibody humanization, affinity maturation and optimization, creating antibodies for numerous applications, including therapeutics.

Binding confirmation and affinity measurement of the antibodies produced can be performed using an assortment of methods, including the state-of-the-art array-SPR based Carterra LSA, Octet (biolayer interferometry BLI), ELISA and flow cytometry.

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details.

LakePharma provides a variety of protein engineering, production, and purification services using both mammalian and bacterial platforms.

Our protein engineering department not only has extensive technical expertise in structural biology and protein design, but also draws from years of experience solving various protein expression and purification challenges. Tags commonly used include Fc, albumin, poly-histidine (His), and FLAG, and fusion protein construction and production is highly streamlined. Additionally, native untagged proteins can be produced with a variety of classic protein purification techniques.

Click here to learn more about TunaCHO for high yield protein production.

Click here for a brief overview of gene-to-antibody and high-throughput antibody service.

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details.

LakePharma offers custom labeling and conjugation services for proteins and antibodies. The chemical modification services include biotinylation, HRP conjugation, fluorophore conjugation, and conjugation to agarose beads or magnetic beads. Large scale conjugation and custom conjugation is available. 

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details. 

LakePharma provides stable cell line development services for in vitro assays, small-scale bioproduction, and large-scale GMP manufacturing. Developed from the same CHO-K1 parental cell line, LakePharma also offers three CHO expression platforms for the production of proteins and antibodies.

	TunaCHO™ for transient production of proteins. In conjunction with LakePharma's transient expression vectors, expression levels can reach as high as 2 g/L. Ideal for screening of many candidates during the discovery phase or production of a handful of candidates for preliminary testing in anticipation of lead candidate selection.
	CHO-ASAP™ for fast stable pool generation and large-scale production followed by purification. This option is useful for production of antibody surrogates or large amounts of a protein used for R&D.
	CHO-GSN™ is a glutamine synthesis (GS) knockout cell line for the generation of a research cell bank and future use as a manufacturing cell line for commercial products. With multiple RCBs used for programs at the clinical stage, this platform offers clients a cell line with lineage documentation and a commercial use license for commercialization (royalty-free option is also available).

LakePharma provides a wide range of bioassays to support and monitor the activities of proteins and antibodies.

Bioassay services include functional measurement of ADCC and CDC activity and kinetic measurement of the interactions between ligands and receptors, including antigens and antibodies. Other services offered include quantification of contaminants, such as endotoxin and mycoplasma. 

Furthermore, quantification of target proteins and antibodies in plasma samples can be reliably determined using ELISA. When not commercially available, ELISAs can be custom developed. 

Finally, custom reporter gene assays, including luciferase, GFP, and beta-galactosidase, can be established to enable a multitude of applications, including the assessment of signal transduction pathways.

Please contact inquiries@lakepharma.com for more information. 

LakePharma offers a full line of protein analytical services. Latest advances in liquid chromatography and mass spectrometry techniques enable LakePharma to perform high resolution characterization of protein samples at a reasonable cost for all researchers. 

LakePharma's protein analytical services can identify a protein by molecular weight, sequence confirm the primary structure of a protein and detect post translational modifications, characterize a protein by aggregation, thermostability, size, charge, and pI, measure a protein's purity/impurity, determine the amino acid sequences of a purified protein sample or discover the amino acid sequence of an antibody, compare one protein or antibody sample to a second sample or biosimilar molecule, and more.

While the services and details are listed on the left, clients are encouraged to discuss their specific needs with LakePharma. Please contact inquiries@lakepharma.com for more information. 

New - Intact mass spec analysis for all recombinant antibody productions.

Located in Hopkinton, MA, LakePharma’s microBiomanufacturing center now offers 69,000-square feet of laboratory, manufacturing and office space to serve your product development, testing, and small scale manufacturing needs.

LakePharma has established its operational infrastructure and Quality systems at its new facility to support plasmid DNA production as well as GMP biologics manufacturing for diagnostic reagents and bulk material for Phase 1 clinical trials. The increased capacity at the site also supports growth in LakePharma’s assay development, bioanalytical, process development and QC services. The site currently has approximately 60 employees and plans to add another 40 positions at the Center by 2020.  This provides the ability to offer fully integrated contract development and manufacturing organization (CDMO) capabilities at a close proximity to Cambridge/Boston.

Are you looking to accelerate your program or simply want to learn more about our services? If you would like to speak to a member of our expert team and arrange for a tour of our cGMP facility in Hopkinton, MA, please contact LakePharma at inquiries@lakepharma.com. 

LakePharma offers integrated solutions on the following areas:

Antibody Discovery, development, and GMP manufacturing
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Mammalian Recombinant Protein Engineering to GMP manufacturing
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Comprehensive Viral Vector Production for Cell and Gene Therapy Applications

Additional Services that Support the Biologics Development

Resources

LakePharma has extensive experience with constructing and producing antibodies in our mammalian platforms. Antibody variable region genes (VH and VL) from a given antibody can be reformatted to encode a different constant region and other antibody-like molecules including Fab, scFv, and bispecific molecules. Multiple species and isotypes are available, with the option of synthesizing the constant region of choice.

These expression constructs can be expressed in HEK293 and CHO cells followed by protein purification, and rapidly produced at scales ranging from milligram to gram quantities. We also offer high throughput 96-block antibody productions to fit your antibody screening needs.

Click here to learn more about TunaCHO for high yield antibody production.

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details.

New - Intact Mass Spec Analysis for All Recombinant Antibody Productions

High resolution mass spectrometers have achieved significant resolving power for large molecules. At LakePharma we apply this unparalleled analytical capability to all recombinant antibodies we produce for our clients to enhance the quality standard, for peace of mind.

Antibodies are treated with PNGase F to remove N-glycans and reduced with DTT prior to intact mass analysis. The resulting spectra not only provide the accurate molecular weights of the antibody sample, but can also identify common modifications such as N-terminal pyroglutamate formation or C-terminal cleavage.

The spectra are included in our Certificates of Analysis. This QC step does not apply to non-standard antibodies such as scFv, bispecifics, antibody fusion proteins, antibody-drug conjugates, and antibodies with engineered sequences and PTM sites, etc.

Click here for a brief overview of gene-to-antibody and high-throughput antibody service.

LakePharma offers a full array of custom antibody characterization strategies for lead identification and functional analysis. We provide a wide variety of functional bioassays to determine antibody activities including effector cell mechanisms of action, T-cell stimulation and proliferation, and immune checkpoint pathway analysis. Custom cell-based or reporter gene bioassays can also be designed to characterize candidate antibodies.

LakePharma’s Antibody Center provides end-to-end services in antibody discovery, engineering, and development. We can help functionally characterize your antibodies at every stage of this process. Other characterization services include an assortment of platforms for affinity measurements which include SPR, BLI, ELISA, and flow cytometry. FcRγ and FcRn binding assays and epitope binning services are also offered. 

Please contact LakePharma at inquiries@lakepharma.com for custom quotes and details.

Additional antibody characterization service categories include:

Affinity Measurement (SPR, BLI, ELISA, FACS) 

FcRγ Binding Assays and FcRn Binding Assays 

Epitope Binning and Mapping 

The LakePharma Vector Center provides a comprehensive suite of viral vector services, including vector engineering, preclinical process development and scale-up production, and analytical development. Production systems offered include both baculovirus (AAV) and mammalian (AAV & Lentivirus). 

Available Viral Vector Systems

- Licensed partner for Oxford Expression Systems flashBAC™, Thermo Fisher Bac-to-Bac®, and BD BaculoGold™ - BIIC storage - Suspension culture - Rapid high titer production (2 weeks)		- Third generation - Four-plasmid system - HEK293 production		- Serotype agnostic - Baculovirus and mammalian helper-free systems - Adherent and suspension culture

Comprehensive Viral Vector Services

- Vector design - Gene synthesis - Genetic cloning - Plasmid production		- Baculovirus - Mammalian - Adherent and suspension culture - Wave bioreactors (300 L)		- High-pressure homogenization - AKTA chromatography - Affinity, IEX, SEC, etc. - Diafiltration - Ultracentrifugation		- Capsid Titer (ELISA) - Genome Titer (ddPCR) - Infectious Titer (TCID) - Purity (PAGE) - Full:Empty Capsid (EM) - Bioburden - Mycoplasma (PCR) - Host cell DNA and protein

For more information and custom quote, please email inquiries@lakepharma.com.